icodextrina 4% - abstract book

Adept® & AdhesionsKey Abstracts

Adept® - Clinical Abstracts

Ease of use of icodextrin 4% solution in the reduction of adhesions following 7

gynaecological surgery in Belgium

Foidart JM, Nisolle M.

Presented as a poster at: International Society of Gynaecological Endoscopy 14th

Annual Congress, London, P6.10, 3-5 April 2005

Clinical experiences with icodextrin 4% solution in open and laparoscopic 8

general surgery in the multicentre ARIEL registry

Ommer A, Walz MK on behalf of the ARIEL registry group.

Presented at: European Association of Coloproctology 5th Scientific and Annual

General Meeting European Association of Coloproctology European Council of

Coloproctology First Annual Meeting Geneva, O34, 16-18 September 2004

Ease of use and safety of icodextrin 4% solution in the prevention of 9

adhesions after general surgery: experience from the multicentre ARIEL registry

Menzies D, Hidalgo M, Walz M K, Duron JJ, Tonelli F.



Coloproctology First Annual Meeting Geneva, P31, 16-18 September 2004

A pilot study of adjuvant intraperitoneal 5-fluorouracil using 4% 10

icodextrin as a novel carrier solution

Hosie KB, Kerr DA, Gilbert JA, Downes M, Lakin G, Pemberton G et al.

Published in: European Journal of Surgical Oncology 2003;29:254-260

Use of anti-adhesion agents in colorectal surgery – focus on infection 11

and anastomosis

Parker M on behalf of the ARIEL Registry contributors.

Presented at: European Association of Coloproctology 4th Annual Meeting, Barcelona

18–20 September 2003. Late Breaking Abstracts 1

Colorectal cancer – adhesions and chemotherapy 13

Wilson M.


18–20 September 2003: Late Breaking Abstracts 3

1

Page

European experience with icodextrin 4% solution in routine 15

surgical practice

Sutton C, Menzies DM, Pouly JL, Duron JJ, Korell M, Walz MK, Minelli L, Tonelli F,

Prieto C, Pascual H.

Presented at: 1st European Endoscopic Surgery Week, Glasgow 15-18 June 2003.

Published in: Reviews In Gynaecological Practice June ; 3 (1): O03


surgical practice

Menzies D, Parker MC, Sutton C, Duron JJ, Walz MK, Tonelli F, Pascual H, Pouly

JL, Korell M, Minelli L, Prieto C.

Presented at: European Council Of Coloproctology, 9th Biennial Congress, Athens,

May 31-June 4 2003

Abdominal drains do not affect antiadherential efficacy of 4% 18

icodextrin:Experimental Study

Infantino A, Bruno C, Roberto G.

Presented at: European Council of Coloproctology 9th Biennial Congress,

Athens, May 31-June 4 2003


surgical practice

Menzies DM, Sutton C, Pouly JL, Duron JJ, Korell M, Walz MK, Minelli L,

Tonelli F, Prieto C, Pascqal H.

Presented at: PAX VIth International Symposium on Peritoneum, Amsterdam 10-12

April 2003. Published in: Adhesions News and Views Abstract Supplement: Symposium

III Abstract III(9)

Demonstrating the clinical and cost effectiveness of adhesion reduction 22

strategies

Wilson MS, Menzies D, Knight AD, Crowe AM.

Published in: Colorectal Disease 2002; 4: 355-360

2

Adept® - Preclinical Abstracts

Effects of intraperitoneal 4% icodextrin solution on the healing of bowel 24

anastomosis and laparotomy incisions in rabbits

Rodgers KE, Verco SJS, diZerega GS.

Published in: Colorectal Disease 2003; 5: (4): 324-330

Prevention of chemotherapy-induced intraperitoneal adhesion 26

formation in rats by icodextrin at a range of concentrations

Conroy SE, Baines L, Rodgers K, Deviren F, Verco SJS.

Published in: Gynecologic Oncology 2003; 88: 304-308

Adhesions – The SCAR Studies(the burden and risk of adhesions)

The SCAR-3 study: 5-year adhesion-related readmission risk following 28

lower abdominal surgical procedures

Parker MC, Wilson MS, Menzies D, Sunderland G, Clark DN, Knight AD

and Crowe AM on behalf of the Surgical and Clinical Adhesions

Research (SCAR) Group.

Published online in: Colorectal Disease 2005; doi: 10.1111/j.1463-1318.2005.00857.x

SCAR-3: what factors affect adhesion-related readmission risk following 29

gynaecological surgery?

Lower AM, Hawthorn R.



The risks of post-operative adhesions in colorectal surgery

Wilson MS on behalf of the Surgical and Clinical Adhesions 30

Research (SCAR) group.




The risk to the patient of an adhesion-related readmission 31

Lower AM.

Presented at 30th British Congress of Obstetrics and Gynaecology, Glasgow,

7-9 July 2004

3

Page

SCAR-3: Comparative risks of colorectal procedures 33

Wilson MS on behalf of the SCAR group.

Presented at: 14th Annual Meeting of The Association of Coloproctology of Great

Britain and Ireland, Birmingham, 28 June – 1 July 2004. Late Breaking Abstract

SCAR 2 - The risk of adhesions following colorectal surgery 35

Sunderland G on behalf of the SCAR panel.


18–20 September 2003. Published in: Late Breaking Abstracts 2

Adhesion-related readmissions following gynaecological laparoscopy or 37

gynaecological laparotomy in Scotland. An epidemiological study of 24,046

patients

Lower AM, Hawthorn RJS, Clark D, Knight AD, Crowe AM on behalf of the

SCAR panel.

Presented at: 19th European Society of Human Reproduction and Embryology Annual

Meeting: xviii53 O-156 29th June - 2nd July 2003. Published in: Human Reprod 2003;

18 (suppl 1): 53

Adhesion-related readmissions following gynaecological laparoscopy 39

in Scotland. An epidemiological study of 24,046 patients

Hawthorn RJS, Lower A, Clark D, Knight AD, Crowe AM, on behalf of the

SCAR panel.


Published in: Reviews in Gynaecological Practice, June 2003; 3 (1): 01

Adhesion related readmissions following colorectal surgery in Scotland. 41

An epidemiological study of 4,912 patients

Parker MC, Wilson MS, Menzies D, Clark D, Knight AD, Crowe AM.

Presented at: European Council Of Coloproctology 9th Biennial Congress, Athens, May

31-June 4 2003

Adhesion-related readmission rates in Scotland between 1996 and 2000 43

Wilson M, Parker M, Menzies D, Lower A, Hawthorn R, Thompson J et al.


April 2003. Published in: Adhesions News and Views Abstract Supplement: Symposium

VII Abstract VII(6)

4

The burden of adhesions - evaluating the clinical impact and the value of 45

adhesion reduction strategies


Presented at: European Association of Coloproctology 3rd Scientific and Annual

General Meeting, Erlangen, September 2002. Abstract Workbook 3-6

The impact of adhesions following colorectal surgery today - 46

evaluating the potential impact tomorrow

Parker MC, Wilson MS, Menzies D, Clark D, Ford I, Knight AD.

Presented at : European Association of Coloproctology 3rd Scientific and Annual


Adhesion related outcomes in 9,599 patients undergoing colon surgery 47

between 1996-98


Presented at: The Association of Coloproctology of Great Britain and Ireland Annual

Meeting, Manchester, June 2002

Adhesions – Medicolegal Considerations

Adhesion-reduction in high-risk surgery – is there a need for consensus? 50

Parker MC.




Towards a UK consensus on adhesion reduction 51

Trew G.

Presented at 30th British Congress of Obstetrics and Gynaecology, Glasgow,

7-9 July 2004

What will we tell our patients and what will we do? 53

Parker MC.



5

Adept® - Clinical Abstracts

6



Ease of use of icodextrin 4% solution in thereduction of adhesions following gynaecologicalsurgery in Belgium

Foidart JM, Nisolle M.

OBJECTIVE: To monitor ease of use and patient acceptability of icodextrin 4%

solution (Adept®) in routine gynecological surgery in Belgium.

DESIGN AND METHODS: With the introduction of 4% icodextrin solution, the Belgium

Adept® Registry (BAR) was established. Gynaecologists from 22 centres evaluated its

ease of use and patient acceptability in routine gynaecological surgery associated with

a risk of adhesions. Anonymised data collection forms were submitted to the BAR

central database.

RESULTS: Routine use of icodextrin 4% solution was assessed in 199 patients (n=148

laparoscopies, n=51 laparotomies). The median volume of icodextrin 4% solution used

for irrigation and instillation was 500 mL and 1000 mL respectively for both

laparoscopies and laparotomies. Most surgeons rated the ease of use (viewing of

surgical field, handling of tissues) of icodextrin 4% solution as ‘excellent’ or ‘good’ and

fluid leakage from surgical sites as ‘normal’ (63% of laparoscopies and 65% of

laparotomies) or ‘less than normal’ (19% of laparoscopies, 14% of laparotomies).

Abdominal discomfort was rated as ‘expected’ in 63% of laparoscopies and 73% of

laparotomies, and ‘less than expected’ in 29% of laparoscopies and 20% of

laparotomies. Abdominal distension figures were comparable.

CONCLUSIONS: Feedback from BAR indicates that icodextrin 4% solution used as an

irrigant and post-operative instillate was very well tolerated by patients and

contributing gynaecologists found it easy to use in surgery for the reduction of

adhesions. Although side effects have not been systematically recorded in BAR, Adept®

overall tolerance was judged to be excellent as was substantiated by the larger pan

European ARIEL registry which assessed safety in 4620 patients.

7




Clinical experiences with icodextrin 4% solution inopen and laparoscopic general surgery in themulticentre ARIEL registry

Ommer A, Walz MK on behalf of the ARIEL registry group.

INTRODUCTION: Major abdominopelvic surgery is associated with a substantial risk

and burden of adhesions. The Adept® Registry for Clinical Evaluation (ARIEL) was

established to evaluate the acceptability of icodextrin 4% solution (Adept®) – an intra-

operative device approved in Europe to reduce post-surgical adhesion formation – in

routine surgery.

PATIENTS AND METHODS: Participating surgeons assessed 1738 patients

undergoing open (1469) or laparoscopic (269) general surgery (45.8% included

adhesiolysis) in 103 surgical centres in 5 European countries. Ease of use, acceptability

and safety of icodextrin were evaluated.

RESULTS: Mean volumes of icodextrin used in open surgery were 871 ml (irrigant) and

999 ml (instillate), in line with the manufacturers’ recommendations (irrigant, 100ml

every 30 minutes; instillate 1L). Ease of use was described as ‘okay’, ‘good’ or

‘excellent’ in most cases (96%). Abdominal discomfort/distension were reported to be

‘less than or as expected’ in most patients (discomfort, 91%; distension, 90%). Drains

were used in 698 patients (47.5%; France 42%, Germany 75%, Italy, 96%, Spain 57%,

UK 37%) and most surgeons (63%) reported drain loss to be 'as expected' (mean ±

SD; 279 ± 312 ml). Peritonitis or intra-abdominal infections/abscess occurred in 0.27%

of patients. The incidence of anastomotic leakage, in 983 open anastomotic

procedures, was 2.7%. In the largest group (colorectal procedures, 761) incidences of

anastomotic leakage were: right colon, 4.5%; rectum, 4.3%; unspecified 3.3%; left

colon, 0%.

CONCLUSION: Icodextrin 4% solution is easy to use and can be used with drains.

In ARIEL, post-operative complication rates were minimal and were in line with rates

published in the general surgery literature.

8



Coloproctology First Annual Meeting Geneva, P31, 16-18 September 2004

Ease of use and safety of icodextrin 4% solution inthe prevention of adhesions after general surgery:experience from the multicentre ARIEL registry

Menzies D, Hidalgo M, Walz M K, Duron JJ, Tonelli F.

AIM: The likelihood of developing adhesions following abdominolpelvic surgery is

substantial. The Adept® Registry for Clinical Evaluation (ARIEL) investigated the

acceptability of icodextrin 4% solution (Adept®) – an intra-operative device approved in

Europe to reduce post-surgical adhesion formation

METHOD: Surgeons from 103 European centres evaluated icodextrin for ease of use,

acceptability and adverse events in 1738 patients (UK 902, Spain 440, Germany 167,

France 141, Italy 88) undergoing open (1469) or laparoscopic (269) general surgery

(45.8% included adhesiolysis).

RESULTS: For open surgery, mean volumes of icodextrin used were 871 ml for

irrigation and 999 ml for instillation. Ease of use was described as ‘okay’, ‘good’ or

‘excellent’ in 96% of cases. In procedures using drains (47.5%), most surgeons (63%)

reported drain loss to be ‘as expected’ (mean ± SD; 279 ± 312 ml). Incidence of

peritonitis or intra-abdominal infections/abscess in open surgery was 0.27%, post-

operative ileus 3.6% and healing or infection of wound sites, 3.8%. In 983 open

anastomotic procedures, 27 leaks (2.7%) were reported. Laparoscopic data will also

be presented.

CONCLUSION: Icodextrin 4% solution was easy to use and can be used with drains.

Post-operative complication rates were in line with published literature on

complications in general surgery.

9

Published in: European Journal of Surgical Oncology 2003;29:254-260

A pilot study of adjuvant intraperitoneal 5-flouracilusing 4% icodextrin as a novel carrier solution

Hosie KB, Kerr DA, Gilbert JA, Downes M, Lakin G, Pemberton G et al.

AIM: This pilot study utilised the sustained intraperitoneal (i.p.) dwell properties of an

iso-osmotic solution of 4% icodextrin to investigate the tolerability, toxicity and

feasibility of home-based i.p. 5FU adjuvant chemotherapy following resective surgery

for colorectal cancer.

METHODS: Twenty eligible patients (Dukes' stage B and C with potentially curative

resection) underwent perioperative Tenckhoff catheter placement. Ten (6 male, 4

female, aged 46-85; mean 67.5 years) received 5FU chemotherapy. After initial flushing

and gradual increase in volumes of 4% icodextrin alone, patients received home-based

i.p. 5FU (150-300 mg/m(2)/day given as equal doses at 12-hourly intervals) for 14 days,

with a 14-day recovery period, for a maximum of 6 courses. Two incurable patients,

treated on compassionate grounds, provided further safety data.

RESULTS: Nine of the 10 patients became proficient in self-treatment with 5FU and

two completed 6 courses. Frequent abdominal pain was the main dose-limiting toxicity

of 5FU, causing withdrawal of three patients after a high (300 mg/m(2)/day) first course

and one following a third course at lower doses. I.p. 5FU concentrations (mean>30000

ngml(-1)) were 1000 fold higher than systemic venous levels. Bacterial peritonitis led to

two withdrawals but was not a frequent event (microbiologically confirmed incidence of

1 per 27 catheter-months).

CONCLUSIONS: Home-based i.p. adjuvant chemotherapy is a feasible treatment

option in patients with surgically resected colorectal carcinoma.

10

Presented at: European Association of Coloproctology 4th Annual Meeting,

Barcelona 18–20 September 2003. Late Breaking Abstracts 1

Use of anti-adhesion agents in colorectal surgery –focus on infection and anastomosis

Parker M on behalf of the ARIEL Registry contributors.

BACKGROUND: Adhesions are an almost inevitable consequence after major

abdominal surgery. The SCAR study demonstrated the particularly high risk of

adhesion-related disease after colorectal surgery1. The rate of re-operative surgery after

initial colorectal surgery is high with associated complications such as inadvertent

enterotomy2,3. There is thus a clear need for the use of an effective anti-adhesion agent

to reduce the formation of adhesions in colorectal surgery.

For any agent to be adopted for use it should reduce adhesions and related

complications but be easy to use, inexpensive and have a good safety profile.

Colorectal surgeons live in fear of anastomotic leaks and while the adage that there are

‘good’ adhesions (those that form around the anastomosis) and ‘bad’ adhesions (those

adhesions that form everywhere else) is a misnomer – a key factor for any colorectal

surgeon is to know that use of an anti-adhesion agent is not going to pose more

problems than it could potentially prevent.

With the introduction of 4% icodextrin solution (Adept®), alongside an ongoing and

rigorous clinical research programme, the opportunity for systematic tracking of early

usage was proposed by a number of adhesion specialists. It was important in an area

where many agents have fallen out of use because of handling difficulties, safety,

patient acceptability problems and high costs.

ARIEL (Adept® Registry for Clinical Evaluation) is a European registry designed to

provide systematic tracking and feedback on the use of 4% icodextrin solution (Adept®)

as an adhesion-reduction agent.

RESULTS: As of July 2003, 640 patients undergoing general surgery have been

included in the database. This number is increasing steadily and provides important

feedback on the acceptability and safety of using Adept® in routine surgery. Most

surgeons scored their overall satisfaction, viewing and handling of Adept® as ‘good’

(74%, 70%, 71% laparotomy; 87%, 91%, 83% laparoscopy). Patient abdominal

discomfort was reported ‘as less than normal’ or ‘as normal’ in 89% of laparotomies

and laparoscopies. Preclinical work with 4% icodextrin solution has established that

there is no difference in anastomotic leak rate compared with either lactated Ringers

Continued on following page...11

solution or surgery alone4. Initial analysis of ARIEL Registry feedback on patients

undergoing open surgery where an anastomosis was

formed, indicates a leak rate of 2.9% which is close to the 4–6% rates most frequently

reported in a recent systematic review of anastomotic leaks after gastrointestinal

surgery5. This and other safety aspects of the use of Adept® are being rigorously

monitored. Reported adverse incidents from ARIEL Registry contributors (solicited

reports) and spontaneous reporting are reassuringly low and consistent with those

expected for a peritoneal instillate.

References:

1. Parker MC, Ellis H, Moran BJ et al. Postoperative adhesions: Ten-year follow-up of 12,584

patients undergoing lower abdominal surgery. Dis Colon Rectum 2001; 44: 822–30.

2. Coleman MG, McLain AD, Moran BJ. Impact of previous surgery on time taken for incision and

division of adhesions during laparotomy. Dis Colon Rectum 2000; 43: 1297–9.

3. Van der Krabben AA, Dijkstra FR, Nieuwenhuijzen M et al. Morbidity and mortality of inadvertent

enterotomy during adhesiotomy. Br J Surg 2000; 87: 467–71.

4. Rodgers KE, Verco SJS, diZerega GS. Effects of intraperitoneal 4% icodextrin solution on the

healing of bowel anastomoses and laparotomy incisions in rabbits. Colorectal Dis 2003; 5:

324–30.

5. Bruce J, Krokowski ZH, Al-Khairy G et al. Systematic review of the definition and measurement

of anastamotic leak after gastrointestinal surgery. Br J Surg 2001; 88: 1157–68.

12


Barcelona 18–20 September 2003: Late Breaking Abstracts 3

Colorectal cancer – adhesions and chemotherapy

Wilson M.

DISCUSSION: In spite of the improvements in the treatment of colorectal cancer over

the past few years, there continues however, to be a significant number of individuals

who suffer from tumours that recur within the peritoneal cavity who are not suitable for

further therapy. These patients suffer from a very poor quality of life and will often die

as a result of malignant bowel obstruction.

The use of intraperitoneal chemotherapy has been investigated in the management of

ovarian cancers and there is evidence that this leads to better cytotoxicity.

Intraperitoneal instillation of agents such as cisplatin and paclitaxel has been shown

to increase the local availability of these agents by up to 1000 times compared with

systemic delivery. Phase II studies have reported complete responses in patients

who had previously relapsed after first line systemic chemotherapy. There are now

some early indications that intraperitoneal hyperthermic chemotherapy after complete

surgical cytoreduction can lead to significant improvements in quality of life as well

as long term survival in patients with bulky peritoneal carcinomatosis of

gastrointestinal origin.

In addition to improving the control of peritoneal disease, there is evidence that the

absorption of the chemotherapeutic agent into the portal blood reduces the formation

of hepatic micrometastases.

Preclinical data show that much of the capillary system associated with the first

microscopic cancerous deposits comes from the portal vein. As drug uptake from the

peritoneal cavity largely occurs through the portal system, intraperitoneal

chemotherapy may be an effective adjunct in those gastrointestinal cancers associated

with a high risk of hepatic spread.

Central to this form of therapy is the mode of drug delivery to the peritoneum. There is

a need to use an agent which is non-toxic and non-irritating to the peritoneum, that

can be used in patients with cancer and one that is slowly absorbed in order to allow

the active drug to be exposed to the peritoneum for as long as possible. It needs to be

stable when heated and in order for the drug to circulate freely post-operatively it

would be of great advantage if the formation of adhesions were limited. 4% icodextrin

solution is a good candidate for this type of therapy as it fulfils all of the above criteria

and has a very good safety profile of use within the abdominal cavity.Continued on following page...

13

The challenge is first to confirm that this type of therapy is feasible and then to go on

to perform prospective randomised studies to see if this approach is the next weapon

to use in the battle against colorectal cancer.

14


Published in: Reviews In Gynaecological Practice June ; 3 (1): O03

European experience with icodextrin 4% solution inroutine surgical practice

Sutton C, Menzies DM, Pouly JL, Duron JJ, Korell M, Walz MK, Minelli L, Tonelli F,

Prieto C, Pascual H.

AIM: When introducing a new procedure or agent into routine surgery it is clinically

responsible to monitor use and not simply rely on clinical trial experience. Icodextrin

4% solution (Adept®) has Europe-wide approval as an adhesion-reduction solution and

is in routine use in many European centres. Alongside an ongoing and rigorous clinical

research programme, the opportunity for systematic tracking of early usage was

proposed by leading adhesion specialists as important in an area where many agents

have fallen out of use because of handling difficulties, patient acceptability problems

and high costs.

METHODS: Following an initial pilot in the UK a European Registry (ARIEL) was

established to allow for systematic tracking and feedback of Adept® use in routine

laparoscopic and open gynaecological and general surgery as an irrigant and/or

postoperative instillate for the reduction of adhesions. A wide array of information is

recorded including: surgery undertaken; Adept® use; surgeon and patient experiences,

and adverse events. Anonymised data submitted centrally allows for close monitoring

of early use as well as inter-centre and inter-country comparisons.

RESULTS: The initial pilot identified the need for a 1.5 L presentation of Adept®

particularly in laparoscopic surgery. Over 270 centres have been recruited to ARIEL to

provide potential feedback on over 7,000 patients (~4,000 Gynaecological and ~3,000

General Surgery). Data on the first 491 laparoscopy patients indicate that 87.4% felt

the use of Adept® was good to excellent in terms of ‘overall satisfaction’ (ease of use,

viewing operative site and handling).

In relation to patient abdominal discomfort associated with a post operative instillate

this was scored as what would be normally expected or less than expected by 89.1%.

ARIEL data is received regularly and updated monthly, latest data will be presented.

CONCLUSIONS: The ARIEL Registry will provide the largest body of experience of an

adhesion reduction agent in routine surgery, providing vital information on the

acceptability of 4% icodextrin solution to surgeons and patients. It also provides an

optimal pharmacovigilance tool to monitor potential complications. Initial data suggests

Adept® is very well received by surgeons and patients as part of routine surgery.

15

Presented at: European Council Of Coloproctology, 9th Biennial Congress,

Athens, May 31-June 4 2003


Menzies D, Parker MC, Sutton C, Duron JJ, Walz MK, Tonelli F, Pascual H, Pouly

JL, Korell M, Minelli L, Prieto C.

AIM: When introducing a new procedure or agent into routine surgery it is clinically

responsible to monitor use and not simply rely on clinical trial experience. Icodextrin

4% solution (Adept®) has Europe-wide approval as an adhesion-reduction solution and

is in routine use in many European centres. Alongside an ongoing and rigorous clinical

research programme, the opportunity for systematic tracking of early usage was

proposed by leading adhesion specialists as important in an area where many agents

have fallen out of use because of handling difficulties, safety, patient acceptability

problems and high costs.

METHODS: Following an initial pilot in the UK a European Registry (ARIEL – Adept®

Registry for Clinical Evaluation) was established to allow for systematic tracking and

feedback of Adept® use in routine open and laparoscopic general and gynaecological

surgery as an irrigant and/or postoperative instillate for the reduction of adhesions.

A wide array of information is recorded including: surgery undertaken; Adept® use;

surgeon and patient experiences, use of drains and adverse events. Anonymised data

submitted centrally allows for close monitoring of early use as well as inter-centre and

inter-country comparisons.

RESULTS: The initial pilot provided useful information on use of Adept® in patients with

drains. 26% of surgeons reported drain loss as ‘greater than expected’ while 64%

reported it ‘as expected’. The median reported loss was 300ml which happened in the

first 60 minutes after drain insertion – 30% of the one litre postoperative instillate. With

around 600ml remaining this pilot information suggests Adept® can be used with drains

– supporting anecdotal experience. Further information will be obtained from the

expanded Registry alongside formalised research. The pilot also identified the need for

a 1.5 L presentation of Adept® particularly in laparoscopic surgery.

Over 270 centres have now been recruited to ARIEL to provide potential feedback on

over 7,000 patients (3,000 General Surgery). Data on the first 263 General Surgery

patients indicated that in terms of ‘overall satisfaction’ (ease of use, viewing operative

site and handling) none of the contributing surgeons was dissatisfied with Adept® use

and 94.3% were satisfied/very satisfied (5.73% not recorded). In relation to patient


abdominal discomfort associated with a post operative instillate this was scored as

what would be normally expected or less than expected by 84.4% - only 1.9%

reported some clinical concern. ARIEL data is received regularly and updated monthly,

latest data will be presented.


adhesion reduction agent in routine surgery, providing vital information on the

acceptability of 4% icodextrin solution to surgeons and patients. It also provides an

optimal Pharmacovigilance tool to monitor potential complications. Initial data suggests

Adept® is very well received by surgeons and patients as part of routine surgery.

17

Presented at: European Council of Coloproctology 9th Biennial Congress, Athens,

May 31-June 4 2003

Abdominal drains do not affect antiadherentialefficacy of 4% icodextrin: Experimental Study

Infantino A, Bruno C, Roberto G.

BACKGROUND: Peritoneal adhesions represent a problem of clinical relevance and

economic impact. About two thirds of intestinal occlusions and sub-occlusions after

abdominal and pelvic surgery are caused by adhesions. A non-viscous anti-adhesion

solution of 4% icodextrin (Adept®, Shire, UK), based on the principle of hydroflotation,

has been developed. A randomised, multicentric study showed that 4% icodextrin is

well tolerated and reduces adhesions formation; the recent literature confirms that also

its chronic use and at a higher concentration (7.5%) is very well tolerated. A database

on the use of 4% icodextrin showed that 26.2% of surgeons refer a loss of liquid

through the drains higher than expected, roughly equal to 30% of the used amount.

To better evaluate whether a decrease of icodextrin efficacy could be related to its loss

through the drains, a preclinical pilot study was conducted on rabbits.

METHODS: Twenty male rabbits, divided into 4 groups (5 rabbits per group),

underwent, in general anaesthesia, median laparotomy with subsequent ileal resection

and termino-terminal anastomosis; the peritoneum of a portion of ascending colon and

ileum around the anastomosis was then removed.

Group 1: Icodextrin 4% (50 ml) was introduced in the peritoneal cavity and 2 clamped

drains, open every 24 hours for 3 hours during the first 3 days following surgery, were

positioned; the leaked liquid was collected. Drains were removed after 3 days.

Group 2: instillation of icodextrin (50 ml) and positioning of drains always

maintained open.

Group 3: instillation of icodextrin (50 ml), but no drains were used.

Group 4: no icodextrin was instilled and no drains were used.

A laparotomy was performed 15 days after surgery. The presence of adhesions was

evaluated by the following “score”: 0= no adhesions; 1= 1 adhesion; 2= 2 adhesions;

3= 2-5 adhesions; 4= extended adhesions or death from mechanical causes due to

adhesions.


RESULTS: Total score per group was: 5 for Group 1; 7 for Group 2; 2 for Group 3

and 13 for Group 4. Loss of liquid through the drains was 19.2% of instilled icodextrin

in Group 1, and 15% in Group 2. Our pilot study shows that icodextrin, 15 days

after surgery, is efficacious in preventing peritoneal adhesions and reducing

adhesions severity.

Even though a reduced number of adhesions was observed in those animals with no

drains (Group 3) compared to animals with drains (Group 1 and 2), the occurrence of

adhesions seems little related to the mild liquid loss, considering the volume (50 ml)

introduced during surgery.

CONCLUSIONS: We conclude that 4% icodextrin is able to prevent adhesions, even

when used in the presence of drains, perhaps with an effect proportional to time of

contact with the peritoneum.

19

Presented at: PAX VIth International Symposium on Peritoneum, Amsterdam 10-

12 April 2003. Published in: Adhesions News and Views Abstract Supplement:

Symposium III Abstract III(9)


Menzies DM, Sutton C, Pouly JL, Duron JJ, Korell M, Walz MK, Minelli L, Tonelli F,

Prieto C, Pascqal H.

BACKGROUND: When introducing a new procedure or agent into routine surgery it is

clinically responsible to monitor use and not simply rely on experiences from clinical

trials. Icodextrin 4% solution (Adept®) has Europe-wide approval as an adhesion

reduction solution and is now available across Europe and is in routine use in many

centres. Alongside an ongoing and rigorous clinical research programme in Europe and

North America, the opportunity to allow for systematic tracking and feedback of early

usage was proposed by a number of leading adhesion specialists.

METHODS: Following an initial pilot in the UK a European Registry (ARIEL) has been

established to allow for systematic tracking and feedback of Adept® use in routine

open or laparoscopic general or gynaecological surgery as an irrigant and/or

postoperative instillate for the reduction of adhesions. A wide array of information is

recorded including: surgery undertaken; Adept® use; surgeon and patient experiences;

use with drains and adverse events. Anonymised data submitted to a central database

allowing for close monitoring of early use across Europe as well as inter-centre and

inter-country comparisons. ARIEL allows for ad hoc follow-up where patients undergo

subsequent surgery.

RESULTS: The initial pilot clearly identified the need for a 1.5 L presentation of Adept®

particularly in laparoscopic surgery. Over 250 centres are now contributing to ARIEL to

provide potential feedback on over 6,000 patients (~3,500 Gynaecological and 2,500

General Surgery). ARIEL data are received regularly and updated monthly. Initial data

on the first 600 patients are illustrated, latest data will be presented.



adhesion-reduction agent in routine surgery, providing vital information on the

acceptability of 4% icodextrin solution to surgeons and to patients. It also provides an

optimal pharmacovigilance tool to monitor potential complications.

Type of surgery

Open Gynae

LaparoscopicGynae

All GeneralSurgery

53.2% 32.6% 10.9% 2.2% 0.0% 0.0% 19.6% 75.0% 0.0% 1.1%

50.0% 36.3% 7.4% 0.0% 0.0% 6.3% 16.6% 73.2% 5.6% 0.7%

4.8% 61.3% 27.4% 0.0% 0.0% 6.5% 11.3% 69.9% 5.9% 2.7%

Surgeon’s overall satisfactionPatient abdominal

discomfort

Exce

llent

Good OK Poor

Bad

Notr

ecor

ded

<No

rmal

Norm

al

<No

rmal

Exce

ssiv

e

21

Published in: Colorectal Disease 2002;4:355-360

Demonstrating the clinical and cost effectiveness ofadhesion reduction strategies


OBJECTIVE: To examine the feasibility of conducting Randomised Controlled Trials

(RCT) in lower abdominal surgery to demonstrate a reduction in adhesion-related

admissions following use of an adhesion reduction product, and to model the cost

effectiveness of such products.

METHODS: The number of patients in each limb of a RCT comparing an adhesion

reduction product to a control has been estimated based on 25% and 50% reductions

in adhesion-related readmissions one year after surgery, for P = 0.05 at a power of

80% and P = 0.01 at a power of 90%. A cost effectiveness model based on the

Surgical and Clinical Adhesions Research Group (SCAR) database has been developed

which calculates the percentage reduction in readmissions required of an adhesion

reduction product to return the cost of investment. It also estimates the cumulative

costs of adhesion-related readmissions for lower abdominal surgery and the cost

savings associated with an adhesion reduction policy using a low or high cost product.

RESULTS: 7.2% of patients undergoing lower abdominal surgery will readmit due to

adhesions in the first year after surgery. To demonstrate a 25% reduction in

readmissions one year after surgery, it is calculated that a RCT would require between

5686 (P = 0.05, power = 80%) and 7766 (P = 0.01, power = 90%) lower abdominal

surgery patients followed-up for one year. A cost effectiveness analysis demonstrates

that routine use of adhesion reduction products costing £50 per patient will payback

the cost of such investment if they reduce adhesion-related readmissions by 16% after

3 years. A product costing £200 will need to offer a 64.1% reduction in readmissions

after 3 years. For the estimated 158,000 lower abdominal surgery operations

conducted in the UK each year, the cumulative costs of adhesion-related readmissions

over 10 years are estimated at £569 Million.

CONCLUSION: Demonstrating the clinical effectiveness of adhesion reduction

products in the RCT setting is unlikely to be feasible due to the large number of

patients required. Products costing £200 or more are unlikely to payback their

direct costs.

22

Adept® - Preclinical Abstracts

23

Published in: Colorectal Disease 2003; 5 (4): 324-330

Effects of intraperitoneal 4% icodextrin solution onthe healing of bowel anastomosis and laparotomyincisions in rabbits

Rodgers KE, Verco SJS, diZerega GS.

OBJECTIVE: Peri-operative lavage and postoperative instillation of a 4% icodextrin

solution reduces de novo formation and reformation of peritoneal adhesions following

abdominal surgery. This experimental study evaluated the effects of 4% icodextrin

treatment on the healing of bowel anastomoses and laparotomy incisions.

MATERIALS AND METHODS: Female New Zealand White rabbits (weight 2.21-2.77

kg) were randomised by ascending weight to one of 3 surgical treatments, each with 2

termination points (6 groups of 8 animals). The treatments were anastomotic bowel

surgery alone or with lavage and postoperative instillation of either 4% icodextrin

solution or Lactated Ringer's Solution (LRS). The solutions were coded A and B by the

supplier, so that the study personnel were blinded to their identity. After the abdomen

was opened, 30 ml of solution A or B was instilled and removed by aspiration prior to

surgery. The ascending colon was then transected 5 cm aboral to the ileocaecal

junction and the ends anastomosed. During surgery, 5 ml of the solution was applied 4

times at the surgical site, and a further 30 ml was administered and aspirated as a

postoperative lavage. Just prior to closure of the abdominal wall, 50 ml of the solution

was administered as a postoperative instillate. Duplicate treatment groups were

terminated 7 and 21 days after surgery and the anastomotic sites inspected for

adhesion and/or abscess formation. In 6 animals per group, an 8-12 cm length of colon

including the anastomotic site was removed for measurement of bursting pressure, and

a section of the abdominal wall including the incision line was tested for breaking

strength. The other 2 animals per group provided tissue for histological analysis of

wound healing at the bowel and incision sites.

RESULTS: There was no significant difference between the 3 treatment groups for any

parameter (P > 0.05). Compared with the surgical control at either day 7 or 21 after

surgery, the administration of solutions A or B did not affect the formation of abscesses

or adhesions, the bursting strength of the bowel, or the tear strength of the abdominal

wall incision. Histological assessment of the quality of wound healing showed no

differences between treatment groups in inflammatory cell infiltration, fibroblast density,

blood vessel formation or collagen maturity.


CONCLUSIONS: The use of a 4% icodextrin solution for peri-operative lavage and

postoperative instillation in a rabbit model of bowel anastomotic healing did not result

in any difference from either LRS treated or untreated surgical controls.

25

Published in: Gynecologic Oncology 2003;88:304-308

Prevention of chemotherapy-induced intraperitonealadhesion formation in rats by icodextrin at a rangeof concentrations

Conroy SE, Baines L, Rodgers K, Deviren F, Verco SJS.

OBJECTIVE: Two controlled in vivo studies in rats have investigated the effect of

icodextrin solution on intraperitoneal chemotherapy-induced adhesion formation. The

first study evaluated the effect of three concentrations of icodextrin (4, 15, 20% w/v) in

comparison to a phosphate-buffered saline (PBS) control in response to intraperitoneal

doxorubicin (n = 40). The second study compared the effect of 4% icodextrin to

Ringers' lactate solution (RLS) control in response to intraperitoneal bleomycin (n = 30).

METHODS: Doxorubicin and bleomycin were administered via a continuous pump and

as a single bolus (bleomycin only). Doxorubicin 2 ml (23.2 g/ml) was delivered via pump

in conjunction with 20 ml of 4, 15, or 20% icodextrin or PBS (n = 10 per group). In the

bleomycin experiments rats received either 2 ml (0.77 U/ml) bleomycin delivered via

pump in conjunction with 15 ml 4% icodextrin or RLS, or 0.77 or 0.077 U bleomycin

delivered in 15 ml 4% icodextrin or RLS administered as a bolus injection (n = 5 per

group). Seven days after the initiation of doxorubicin treatment and 9 days after

initiation of bleomycin treatment, the rats were euthanized by CO2 and the extent of

peritoneal adhesion formation was evaluated using an 8-point scoring system.

RESULTS: When icodextrin was administered in conjunction with doxorubicin there

was a reduction in the formation of adhesions compared to PBS. Efficacy increased

with the concentration of icodextrin used. The lowest dose of bleomycin (0.077 U)

caused very few adhesions. Results with bleomycin 0.77 U/ml (pump) and 0.77 U

(bolus) showed that 4% icodextrin was significantly more effective than RLS at

preventing adhesion formation, irrespective of the dosing regimen.

CONCLUSIONS: These studies suggest that 4% icodextrin may reduce adhesion

formation caused by intraperitoneal chemotherapy.

26

Adhesions – The SCAR Studies (the burden and risk of adhesions)

27

Published online in: Colorectal Disease 2005; doi:10.1111/j.1463-1318.2005.00857.x

The SCAR-3 study: 5-year adhesion-relatedreadmission risk following lower abdominal surgicalprocedures

Parker MC, Wilson MS, Menzies D, Sunderland G, Clark DN, Knight AD and Crowe

AM on behalf of the Surgical and Clinical Adhesions Research (SCAR) Group.

OBJECTIVE: The Surgical and Clinical Adhesions Research (SCAR) and SCAR-2

studies demonstrated that the burden of adhesions following lower abdominal surgery

is considerable and appears to remain unchanged despite advances in strategies to

prevent adhesions. In this study, we assessed the adhesion-related readmission risk

directly associated with common lower abdominal surgical procedures, taking into

account the effect of previous surgery, demography and concomitant disease.

METHODS: Data from the Scottish National Health Service medical record linkage

database were used to assess the risk of an adhesion-related readmission following

open lower abdominal surgery during April 1996-March 1997.

RESULTS: Patients undergoing lower abdominal surgery (excluding appendicectomy)

had a 5% risk of readmission directly related to adhesions in the 5 years following

surgery. Appendicectomy was associated with a lower rate of readmission (0.9%), but

contributed over 7% of the total lower abdominal surgery patient readmission burden.

Panproctocolectomy (15.4%), total colectomy (8.8%) and ileostomy surgery (10.6%)

were associated with the highest risk of an adhesion-related readmission. Overall, the

risk of readmission was doubled in patients who had undergone abdominal or pelvic

surgery within 5 years of the incident operation. A higher risk of readmission was also

recorded in patients aged < 60 years compared with those aged >60 years. The

effect of gender was assessed. However, as the surgical codes used were found to be

skewed towards women, these data have not been reported. Readmission risk was

slightly higher in patients with concomitant peritonitis compared with patients without

peritonitis. In contrast, Crohn's disease had no effect on risk. Patients with colorectal

cancer had a lower risk of adhesion formation. However, this may have been due to the

type of surgery performed in this patient group.

CONCLUSION: The identification of high-risk patient subgroups may assist in

effectively targeting adhesion-prevention strategies and the proffering of preoperative

advice on adhesion risk.

28



SCAR-3: what factors affect adhesion-relatedreadmission risk following gynaecological surgery?

Lower AM, Hawthorn R.

OBJECTIVES: To determine adhesion-related readmission risk during 5 years following

laparoscopic gynaecological surgery and to assess the influence of previous

abdominopelvic surgery, surgery type, and concomitant disease, on risk.

DESIGN AND METHODS: This epidemiological study used data from the Scottish

National Health Service medical record linkage database to determine an incident

cohort of patients undergoing laparoscopic surgery during 1996-1997. These patients

were followed up for adhesion related readmissions over a 5-year period.

Readmissions were identified using surgical codes selected from the Office of

Population Censuses and Surveys, Fourth Edition (OPSC4) and diagnostic codes from

the International Code of Diseases, Tenth Edition (ICD10).

RESULTS: A total of 6,276 laparoscopic procedures (excluding sterilisations) were

conducted in Scotland during 1996-1997 and 33% of patients had undergone surgery

within the previous 5 years. Diagnoses at the time of surgery included endometriosis

(18%), inflammatory disease of the female genitalia (12%) and pain (33%). The overall

risk of a direct adhesion-related readmission within 5 years was 2.5%. This increased

to 3.5% in patients that had previously undergone abdominopelvic surgery.

Concomitant endometriosis and inflammatory disease did not increase readmission

risk. However, ahesiolysis, which occurred in 4% of procedures, was associated with

the highest risk of readmission; patients who had previously undergone surgery and

subsequently underwent adhesiolysis had a risk of readmission of 6.8%.

CONCLUSIONS: This study indicates that adhesiolysis procedures and previous

abdominopelvic surgery are associated with an increased risk of adhesions following

laparoscopic gynaecological surgery.

29




The risks of post-operative adhesions in colorectalsurgery

Wilson MS on behalf of the Surgical and Clinical Adhesions Research (SCAR)

group.

INTRODUCTION: The burden of adhesion-related readmissions following lower

abdominal surgery remains unchanged1. This study identifies the surgical procedures

associated with the greatest risk of adhesion-related readmission, and assesses the

effects of previous surgery, age and concomitant disease (cancer, peritonitis) on

readmission risk.

PATIENTS AND METHODS: Patients undergoing open lower abdominal surgery in

1996/1997 were followed up for 5 years using the Scottish Patient Record Linkage

Database. Data were analysed on a patient readmission basis.

RESULTS: 12,756 patients who underwent lower abdominal surgery were identified.

Within 5 years, 3.8% were readmitted with problems directly related to adhesions.

Surgery within the previous 5 years increased the risk of readmission (5.8% vs. 2.5%);

the risk further increased in patients aged < 60 years old (8.5%), or those < 60 years

old and female (9.4%). Excision of the colo-rectum led to a risk of readmission directly

related to adhesions of 11.7% which in combination with peritonitis increased to 14.3%

over 5 years.

CONCLUSIONS: Adhesion-related readmissions following lower abdominal surgery

may be more common in a number of patient sub-groups. Patients who have

undergone previous abdominal surgery, those aged < 60 years, and those undergoing

colorectal surgery all appear to have a greater risk; in addition, females may be at

higher risk than males. Identification of these sub-groups may enable adhesion-

reduction strategies to be targeted more effectively and may help to improve

awareness of which patients are most likely to be affected by adhesions.

References:1. Sunderland G. SCAR2 – The risk of Adhesions Following Colorectal Surgery. Colorectal Dis

2003; 5: 598. LBA2 (Abstr.).

30

Presented at 30th British Congress of Obstetrics and Gynaecology, Glasgow, 7-9

July 2004

The risk to the patient of an adhesion-relatedreadmission

Lower AM.

All surgical procedures place a patient at risk and in our increasingly litigious society,

informing the patient of the benefits versus the risks is an essential part of the consent

process, yet defining what is a serious or a frequently occurring risk, versus what is

not, can be a difficult line to tread. Evidence-based approaches are recognised as

definitive methods for defining and ordering risk, but provision of this information

needs to be tailored to the individual condition and values of each patient, as well as

the skills of the surgical team. These caveats can explain hospital variations in the

provision of risk information, but are there certain types of serious or frequently

occurring risks which we are all duty-bound to inform?

The Surgical and Clinical Research (SCAR) group have undertaken key research into

the epidemiology of adhesions and the risk of adhesion-related readmissions. Our

initial research1 established that up to 1 in 3 patients in Scotland undergoing open

gynaecological surgery in 1986 were readmitted on average 1.9 times over a 10 year

period, for a problem potentially related to adhesions, or for further intra-abdominal

surgery that could be complicated by adhesions from previous surgery. More recently

we have examined the adhesion-related readmission risk of therapeutic and diagnostic

gynaecological laparoscopy procedures2. For medium or high risk procedures

conducted in 1996, the risk of an adhesion-related readmission one-year after surgery

was between 1 in 70 and 1 in 80. This risk assessment was similar to the risk of a

readmission for open gynaecological procedures conducted in 1996, which ranged

from 1 in 50 for procedures on the ovary , to 1 in 170 for open uterine surgery. The risk

of adhesion-related readmission due to laparoscopic sterilisations was comparably low

at 1 in 500. These estimates excluded the risk of readmission for procedures possibly

related to or complicated by adhesions and should be regarded as underestimates of

the likely risks of adhesion complications faced by the patient.

The finding that certain types of laparoscopic surgery conferred a similar risk of

adhesion-related readmissions to open surgery, has led us to further investigate those

patients at highest risk. The effects of variables and co-variables including previous

surgery, age and concomitant diseases have been assessed and support the view that

certain patients have an even greater risk of a direct adhesion-related readmission than

already reported.


A review of key consent risk information provided for gynaecological procedures

revealed the following; a less than 1 in 1003 risk of a serious complication due to

general anaesthesia and an estimated 1 in 1000 risk of pain, bleeding, infection or

damage to the bowel or bladder in sterilisation procedures. These risks are all lower

than the reported risk of readmission for conditions directly related to adhesions in the

year following surgery. Our research indicates that few consent forms mention

adhesion complications and none include an estimate of the associated risk.

Adhesion-related readmissions are a serious complication of gynaecological surgery

which can lead to infertility and in the most serious cases small bowel obstruction and

death. Informing patients of these risks would seem appropriate based on

comparisons to other surgical risk data currently provided.

References:1. Lower AM, Hawthorn RJS, Ellis H et al. The impact of adhesions on hospital readmissions over

ten years after 8489 open gynaecological operations: an assessment from the Surgical and

Clinical Adhesions Research Study. Br J Obstet Gynaecol 2000; 107: 855-862.

2. Lower AM, Hawthorn RJS, Clark D et al. Adhesion-related readmissions following

gynaecological laparoscopy or laparotomy in Scotland. An epidemiological study of 24,046

patients. Human Reprod 2004; 19(8): 1877-85.

3. Addenbrooke’s NHS Trust, Gynaecological Services. Patient agreement to investigation of

treatment: Laparoscopic sterilisation.

32



SCAR-3: Comparative risks of colorectal procedures

Wilson MS on behalf of the SCAR group.

INTRODUCTION: We recently reported that the burden of adhesion-related

readmissions in Scotland following lower abdominal surgery in the 1990s remains

unchanged.1 The objective of this study was to determine which patient subgroups and

which procedures are associated with the greatest risk of an adhesion-related

readmission. This may allow adhesion-reduction strategies to be targeted and patients

to be better informed of these risks.

METHODS: A cohort of patients undergoing lower abdominal laparotomies in 1996 /

1997 was followed up for 5 years using the Scottish Patient Record Linkage database.

Adhesion-related readmissions were classified by surgical members of the SCAR

(Surgical and Clinical Adhesions Research) panel as directly related or possibly related

to adhesions or as procedures that could be complicated by adhesions, based on

OPCS4* surgical codes and ICD10† diagnostic codes. The cohort was analysed on a

patient readmission basis for the overall data, for those who had or had not undergone

previous surgery, by surgical sub-category and according to the presence or absence

of concomitant conditions.

RESULTS: In Scotland between April 1996 and March 1997, 12,756 patients

underwent open lower abdominal surgical procedures (excluding gynaecological

interventions) that could result in adhesion formation. The percentages of patients who

were readmitted to hospital within 5 years after surgery are shown in the table overleaf.

CONCLUSIONS: These data suggest that one in 20 patients will be readmitted to

hospital as a direct consequence of adhesions within 5 years of colorectal surgery. This

risk doubles in patients undergoing total colectomies with or without ileostomies.

Previous abdominal surgery and peritonitis at the time of surgery may increase the risk

still further. Our findings show that the risks of a directly adhesion-related patient

readmission are high.We have been able to define certain patient groups for whom the

risk is greatest and who should be considered for anti-adhesion therapies.

*OPCS4, Office of Population Censuses and Surveys, Fourth Edition.†ICD10, International Classification of Diseases,Tenth Edition.


Surgical category Adhesion-related readmissions within 5 years of surgery (%)

Directly Possibly Complicatedrelated related by adhesions

All patients (n=12756) 3.8 11.6 6.1

Colon (n=3176) 5.0 13.6 8.4

Total colectomies/ileostomies 11.7 20.5 15.9- with peritonitis 14.3 14.3 7.1- with colorectal cancer 4.0 10.0 12.0

Right hemicolectomies (ALL) 3.8 14.3 4.5- with peritonitis 2.9 11.4 2.9- with colorectal cancer 2.9 13.9 4.9

Left hemicolectomies (ALL) 4.9 11.8 8.8- with peritonitis 10.5 21.1 13.2- with colorectal cancer 5.0 11.4 5.2

Rectum (n=1690) 5.2 12.2 15.7

Excision of rectum 5.6 12.5 15.7- with peritonitis 6.4 10.4 27.2- with colorectal cancer 5.2 13.5 13.3

Reference:1. Sunderland G. SCAR2 – The risk of Adhesions Following Colorectal Surgery. Colorectal Dis

2003; 5: 598. LBA2 (Abstr.).

34


Barcelona 18–20 September 2003. Published in: Late Breaking Abstracts 2

SCAR 2 - The risk of adhesions following colorectalsurgery

G Sunderland on behalf of the SCAR Panel.

BACKGROUND: Adhesions occur in 95% of patients following lower abdominal

surgery. In most cases their consequences are silent, but epidemiological research by

the SCAR group1 suggest that up to 7% of patients undergoing lower abdominal

surgery will be readmitted directly due to adhesions in the 10-year period following

surgery. Furthermore, a substantially larger number of other readmissions will be

related to adhesions e.g. pain or small bowel obstruction. The SCAR group have

considered the problems of designing adhesion-related outcome trials and

demonstrated that a randomised controlled trial with over 5000 lower abdominal

surgery patients completing a one year follow-up would be required to demonstrate a

25% reduction in readmissions2. To establish the feasibility of undertaking such a study,

updated epidemiological research using the Scottish morbidity record system has been

conducted. We report on a colorectal sub-section of this research and the wider

consequences of these and other data on the implications for a trial examining the

effect of 4% icodextrin solution (Adept®) on the rate of adhesion-related readmissions.

RESULTS: A cohort of 4912 patients undergoing colorectal surgery in 1996/1997 was

identified and all subsequent adhesion-related readmissions followed. The cumulative

number of adhesion-related readmissions in the 4 years following surgery are shown in

Table 1. In the first year following colorectal surgery these readmissions were directly

related in 103 patients (2.1%) and directly/possibly related in 418 patients (8.5%). This

demonstrates that up to 45% of patients will be readmitted more than once in the first

year due to adhesion-related problems.

Readmission rates 1 year following surgery were very similar for the consecutive cohort

years 97/98 and 98/99. This research confirms the earlier SCAR study findings and

suggests that adhesion-related readmissions following colorectal surgery remain a

consistent problem in Scotland over the last 10 years, a fact also reflected in

readmission data for all lower abdominal surgery. These findings also suggest that the

Scottish Medical Record Linkage System can be utilised to follow-up a large cohort of

patients as part of a clinical trial or an adhesion-reduction initiative. We are actively

working to establish a clinical outcomes study with Adept®. This would be one of the

largest surgical studies ever and one that could be undertaken uniquely in Scotland.

Further details will be presented.


Table 1. Cumulative number of adhesion-related readmissions in the 4 years

following surgery.

References:1. Parker MC, Ellis H, Moran BJ et al. Postoperative adhesions: Ten year follow-up of 12,584

patients undergoing lower abdominal surgery. Dis Colon Rectum 2001; 44: 822–30.

2. Wilson MS, Menzies D, Knight AD, Crowe AM. Demonstrating the clinical and cost effectiveness

of adhesion reduction strategies. Colorectal Dis 2002; 4: 355–60.

Surgery typeNo. ofinitial

patients

Colorectal surgery1) Directly2) Directly/Possibly

4,912

Cumulative no. and % of adhesion-related readmissions in years following surgery

Year 1 Year 2 Year 3 Year 4

136 2.8%608 12.4%

212 4.3%959 19.5%

287 5.8%1262 25.7%

325 6.6%1459 29.7%

36

Presented at: 19th European Society of Human Reproduction and Embryology

Annual Meeting: xviii53 O-156 29th June - 2nd July 2003. Published in: Human

Reprod 2003;18 (suppl 1): 53

Adhesion-related readmissions followinggynaecological laparoscopy or gynaecologicallaparotomy in Scotland. An epidemiological study of24,046 patients

Lower AM, Hawthorn RJS, Clark D, Knight AD, Crowe AM on behalf of the SCAR

panel.

INTRODUCTION: Adhesions are a significant cause of female infertility. Our previous

research examined the burden of adhesion-related readmissions following

gynaecological laparotomies conducted in Scotland in 1986. Laparoscopic surgery was

in its relative infancy at the time and adhesion-related admission data were not readily

identifiable. The objective of this study was to determine and compare the

epidemiology of adhesion-related readmissions for gynaecological laparoscopy and

laparotomy undertaken in the same year.

MATERIALS AND METHODS: The Scottish morbidity record system was used to

identify all gynaecological laparoscopic and laparotomy procedures (excluding

caesarians) conducted in the financial year March 1996 to April 1997 and then track all

adhesion-related readmissions. Laparoscopic procedures were subdivided into high

risk (adhesiolysis procedures), low risk (fallopian tube sterilisation procedures), medium

risk (all other procedures). Laparotomy procedures were subdivided by operation site.

Adhesion-related readmissions in the subsequent four years following the initial

operations were identified using OPCS4 surgical and ICD10 disease codes and

categorised as either directly related, possibly related or operations not caused by

adhesions but potentially complicated by them.

RESULTS: A cohort of 15,197 patients undergoing laparoscopic procedures and 8,849

patients undergoing laparotomy procedures were identified. The cumulative number of

readmissions either directly or possibly related to adhesions in the one to four year

period following surgery are detailed below and also presented as a percentage of the

initial number of surgical procedures.


The number and percentage of patients readmitting one year following laparoscopic

surgery were 792 (5.2%) and 433 (4.9%) following laparotomies.

CONCLUSIONS: It is widely assumed that laparoscopic procedures result in fewer

adhesions than laparotomies. These data support this view for laparoscopic

sterilisation procedures, which form the majority of laparoscopic procedures in

Scotland. Other laparoscopic procedures do however have a rate of adhesion-related

readmission which is at least comparable to that for laparotomy procedures. Thus for

women wishing to conceive and particularly when performing surgery of the tubes and

ovaries, routine surgical practice should adopt appropriate adhesion reduction

strategies. Not only may this improve pregnancy rates - but it will also reduce the wider

burden of adhesion-related readmissions including pain and small bowel obstruction.

Reoperative complications associated with adhesions are a rising cause of medico-

legal litigation and may also be reduced.

Surgery type

Laparoscopy

- High risk

- Medium risk

- Low risk

- OVERALL

Laparotomy

- Fallopian tube

- Ovary

- Uterus

- Vagina

- OVERALL

705

5571

8921

15197

466

328

8024

31

8849

110 15.6% 160 22.7% 203 28.8% 254 36.0%

586 10.5% 922 16.6% 1203 21.6% 1491 26.8%

267 3.0% 526 5.9% 743 8.3% 930 10.4%

963 6.3% 1608 10.6% 2149 14.1% 2675 17.6%

72 15.5% 118 25.3% 155 33.3% 178 38.2%

59 18.0% 94 28.7% 133 40.5% 166 50.6%

442 5.5% 716 8.9% 928 11.6% 1115 13.9%

0 0.0% 0 0% 3 9.7% 3 9.7%

573 6.5% 928 10.5% 1219 13.8% 1462 16.5%

No. ofinitial

Patients

Cumulative no. and % of direct or possible adhesion related readmissions in years following surgery

Year 1 Year 2 Year 3 Year 4

38


Published in: Reviews in Gynaecological Practice, June 2003; 3 (1): 01

Adhesion-related readmissions followinggynaecological laparoscopy in Scotland.An epidemiological study of 24,046 patients

Hawthorn RJS, Lower A, Clark D, Knight AD, Crowe AM, on behalf of the SCAR

panel.

AIM: Our previous research examined the burden of adhesions following

gynaecological laparotomies undertaken in Scotland in 1986 when laparoscopic

surgery was in its relative infancy. The objective of this study was to determine and

compare the current epidemiology of adhesion-related readmissions for gynaecological

laparoscopy and laparotomy.

METHODS: From the Scottish morbidity record system we identified all gynaecological

surgery (excluding caesareans) conducted in the financial year March 1996 to April

1997 and tracked subsequent adhesion-related readmissions until 2001. Laparoscopies

were subdivided into high risk (adhesiolysis), low risk (tubal sterilisation), medium risk

(all other procedures). Laparotomies were subdivided by operative site. Adhesion-

related readmissions were identified and categorised as either directly or possibly

related, or operations not adhesion related but potentially complicated by them.

RESULTS: A cohort of 15,197 patients undergoing laparoscopies and 8,849 patients

undergoing laparotomies were identified. The cumulative number of readmissions and

percentage of the initial surgical procedures directly/possibly related to adhesions in

the four year period following surgery were identified. For the 705 high risk

laparoscopies undertaken in 1996/97 there were 254 (36%) adhesion-related

readmissions in the subsequent four years. For medium risk (5571) and low risk (8921)

laparoscopy there were 1492 (26.8%) and 930 (10.4%) readmissions – 2675 (17.6%)

overall. For laparotomy patients, of the fallopian tube cohort (466) there were 178

(38.2%) readmissions compared to ovary (328) 166 (50.6%); uterus (8024) 1115

(13.9%) and vagina (31) 2 (9.7%) – 1462 (16.5%) overall.

CONCLUSIONS: It is widely assumed that laparoscopic procedures result in fewer

adhesions than laparotomies. While these data support this view for laparoscopic

sterilisations, which form the majority of laparoscopies in Scotland, other laparoscopic

procedures do however have a rate of adhesion-related readmission at least

comparable to that for laparotomies. Thus for women wishing to conceive, and

particularly for surgery of the tubes and ovaries, surgical practice should adopt routine


adhesion reduction strategies. Not only may this improve pregnancy rates - but will

also reduce the wider burden of adhesions including pain and small bowel obstruction.

Reoperative complications associated with adhesions and laparoscopic surgery are a

rising cause of medico-legal litigation which may also be reduced.

40

Presented at: European Council Of Coloproctology 9th Biennial Congress, Athens,

May 31-June 4 2003

Adhesion related readmissions following colorectalsurgery in Scotland. An epidemiological study of4,912 patients


INTRODUCTION: Postoperative adhesions affect the health and fertility of patients,

make reoperative surgery problematic and pose a significant impact on health

resources. Our previous research (SCAR) demonstrated that the burden of adhesion-

related readmissions following colorectal surgery in 1986 was high. Since 1986 there

have been advances in surgical techniques and anti-adhesion agents. The objective of

this study was to assess the epidemiology of adhesions following colorectal surgery 10

years on.

MATERIALS AND METHODS: The Scottish morbidity record system tracks all hospital

readmissions on an individual patient basis. This was used to identify all patients

undergoing colorectal surgery in the financial year April 1996 to March 1997 and all

subsequent adhesion-related readmissions were then tracked over the following four

years - categorised as either directly-related, possibly-related or operations not caused

by adhesions but potentially complicated by them.

RESULTS: A cohort of 4,912 colorectal patients was identified. The cumulative number

of adhesion-related readmissions following surgery are presented as a percentage of

the initial number of procedures in the table below.

Year 1

Surgery typeNo. ofinitial

Patients

Colorectal surgery 4,912

Cumulative No. and % of adhesion-related readmissions in years following surgery

Year 2 Year 3 Year 4

1) Directly 136 2.8% 212 4.3% 287 5.8% 325 6.6%

2) Directly/Possibly 608 12.4% 959 19.5% 1262 25.7% 1459 29.7%

3) Directly/Possibly/Complicated

1155 22.7% 1674 34.1% 2088 42.5% 2354 47.9%


The year one adhesion-related readmission data for a cohort of patients undergoing

colorectal surgery in 1997/98 (N=4,906) and in 1998/99 (N=4,909) demonstrated very

similar rates of readmission within each readmission category. The number and

percentage of patients readmitting one year following colorectal surgery were 103

(2.1%) directly related, 418 (8.5%) direct/possibly related and 853 (17.3%) for all three

categories, demonstrating that for patients readmitting, up to 31% readmit more than

once in the first-year following surgery due to adhesion-related problems.

CONCLUSIONS: Adhesion-related readmissions following colorectal surgery in the late

1990’s remains high and although the majority of readmissions occur in the first year

following surgery, readmissions in subsequent years remain a significant burden. This

confirms the earlier SCAR study findings and shows that despite advances in

colorectal surgery since 1986 this has had little impact on the burden of adhesions.

Action on adhesions has received low priority despite the potential improvements in

patient outcomes, reduced healthcare costs and theatre time. Surgeons have been

awaiting RCT evidence of the impact of new anti-adhesion agents on clinical outcomes

before using them but our assessment of patient numbers required in such a trial

(>6,000) suggests this is impractical.

Pending resolution of this problem with alternate strategies, it may be appropriate to

accept the use of improvements in surrogate markers of adhesion reduction as

demonstration of efficacy of the simpler less expensive anti-adhesion agents.

42


April 2003. Published in: Adhesions News and Views Abstract Supplement:

Symposium VII Abstract VII(6)

Adhesion-related readmission rates in Scotlandbetween 1996 and 2000

Wilson M, Parker M, Menzies D, Lower A, Hawthorn R, Thompson J et al.

BACKGROUND: Adhesion-related readmissions represent a significant burden on

healthcare. Despite the increasing availability of adhesion-reduction products to

potentially reduce this burden their prophylactic use is limited. Recent research by the

SCAR Panel suggests that robust randomised controlled trial outcome data is unlikely

ever to be available. An alternative considered by the SCAR Panel is to undertake a

study within a readily-available patient tracking database such as the Scottish patient

record linkage database used in the original SCAR epidemiological study. This has the

potential to allow for reliable and automated follow-up which could be used to

determine the clinical effect of routine use of 4% icodextrin solution (Adept®) on

adhesion-related outcomes, if there are no significant differences in readmissions

between years and the variance in readmissions rates between hospitals is not large.

This analysis sought to establish this for the period 1996 to 2000.

METHODS: Using OPCS 4 codes incident cohorts of patients undergoing lower

abdominal surgery, gynaecological surgery, gynaecological laparoscopic surgery (high

or low adhesion risk) were identified in 1996, 1997 and 1998. For each cohort time to

first adhesion-related readmission identified by OPCS 4 or ICD10 codes were

established over a 2 year period. For each hospital, and cohort year undergoing lower

abdominal surgery the variance in the percentage of patients readmitting due to

adhesions within the first year following surgery was also established.

RESULTS: The incident cohorts for each year and corresponding percentage directly or

possibly related readmissions were tabulated.


The variance in percentage readmissions between hospitals was lowest in lower

abdominal surgery.

CONCLUSIONS: Initial readmission rates due to adhesions following lower abdominal

surgery or gynaecological surgery appear to be similar between years and reflect no

reduction in the burden of adhesion readmissions since the original SCAR study. High-

risk laparoscopic gynaecological procedures including drainage of ovarian cysts,

division of adhesions and complicated reversals of sterilisations have a higher risk but

with a tendency for improvement over time.

Surgery type Incident cohort numbers% adhesion-related

readmissions at one year

1996

Lower abdominal surgery 13054

Gynaecological surgery 8849

Gynaecological laparoscopyhigh-risk

705

Gynaecological laparoscopy low-risk

8921

1997

13265

8723

852

7843

1998

12796

8683

879

7455

1996

7.75%

4.89%

11.77%

2.5%

1997

7.86%

4.46%

10.92%

2.36%

1998

7.62%

4.66%

8.76%

2.37%

44

Presented at: European Association of Coloproctology 3rd Scientific and Annual


The burden of adhesions - evaluating the clinicalimpact and the value of adhesion reductionstrategies


NB French and Spanish translations available from Shire France and Shire Iberica

INTRODUCTION: To evaluate the clinical impact and value of using an adhesion

reduction strategy we examined the feasibility of conducting Randomised Controlled

Trials (RCT) in lower abdominal surgery to demonstrate a reduction in adhesion-related

admissions following use of an adhesion reduction product. The cost effectiveness of

such products was also modeled.

METHODS: The number of patients required in a RCT comparing an adhesion

reduction product to a control has been estimated based on 25% and 50% reductions

in adhesion-related readmissions one year after surgery. A cost effectiveness model

based on the Surgical and Clinical Adhesions Research Group (SCAR) database has

been developed to assess the level of reduction in adhesion-related readmissions

required to return the cost of investment in an adhesion reduction strategy. The

cumulative costs of adhesion-related readmissions for lower abdominal surgery and the

cost savings associated with an adhesion reduction policy using a low or high cost

product are also assessed.

RESULTS: To demonstrate a 25% reduction in the 7.2% readmissions one year after

surgery (from SCAR data), it is estimated that a RCT would require between 5,686

(P=0.05, power=80%) and 7,766 (P=0.01, power=90%) lower abdominal surgery

patients followed-up for one year. A cost effectiveness analysis demonstrates that

routine use of adhesion reduction products costing £50 per patient will payback the

cost of such investment if they reduce adhesion-related readmissions by 16% after 3

years. A product costing £200 will need to offer a 64.1% reduction in readmissions

after 3 years. For the estimated 158,000 lower abdominal surgery operations

conducted in the UK each year, the cumulative costs of adhesion-related readmissions

over 10 years are estimated at ~€886 Million.

DISCUSSION: Demonstrating the clinical effectiveness of adhesion reduction products

in the RCT setting is unlikely to be feasible due to the large number of patients

required. High priced adhesion reduction agents are unlikely to payback their

direct costs.

45

Presented at : European Association of Coloproctology 3rd Scientific and Annual


The impact of adhesions following colorectal surgerytoday - evaluating the potential impact tomorrow

Parker MC, Wilson MS, Menzies D, Clark D, Ford I, Knight AD.

NB French and Spanish translations available from Shire France and Shire Iberica

INTRODUCTION: The SCAR study showed the significant burden of adhesion-related

disease. While there are a number of anti-adhesion agents available, evidence that

routine use will reduce the burden of disease and be cost effective is required.

Modeling work has shown that randomised controlled outcome studies require large

numbers of patients. A practical approach to overcoming this is to progress a study in

a surgery population with an existing, reliable follow-up mechanism. To establish the

feasibility of this type of study it is necessary to identify a study population and

establish the variance in adhesion-related outcomes.

METHODS: Using the Scottish Record Linkage database, individual patient adhesion-

related outcomes for all patients undergoing colorectal surgery (open and laparoscopic)

at 6, 12, 18 and 24 months in 1996, 1997 and 1998 have been assessed. These data

has been used to identify the number of hospitals required in a cluster randomisation

population study to demonstrate a reduction in adhesion-related outcomes.

RESULTS: The percentage of adhesion-related readmissions classified as directly or

possibly related one year after open colon surgery in Scotland in 1996 (n=3199), 1997

(n=3198) and 1998 (n=3223), are as follows; 8.5% (2.9% directly, 5.6% possibly), 9.0%

(3.1%, 5.9%), 9.2% (2.7%, 6.5%). The most common directly-related reoperation was

freeing of adhesions. Kaplan-Meier plots of time to first adhesion-related readmissions

for these colon surgery populations will be compared by cohort year and also to larger

lower abdominal surgery populations.

DISCUSSION: This work provides important insight to the impact that colorectal

surgery today has on adhesion-related outcomes and builds on the original work

undertaken in the SCAR study. The variance of adhesion-related readmission rates at a

hospital level has been used to estimate the number of patients and hospital cluster

sites required to progress an outcomes study. It will allow us to confirm the viability of

a population based clinical outcome study.

46

Presented at: The Association of Coloproctology of Great Britain and Ireland

Annual Meeting, Manchester, June 2002

Adhesion related outcomes in 9,599 patientsundergoing colon surgery between 1996-98


INTRODUCTION: The SCAR study showed the significant burden of adhesion-related

disease. While there are a number of anti-adhesion agents available, evidence that

routine use will reduce the burden of disease and be cost effective is required.

Modeling work has shown that randomised controlled outcome studies are impractical

because of the number of patients and length of follow-up required. A possible

alternative is to progress a population based clinical outcome study. However it is

necessary to identify a study population representative of the general surgical

population. In undertaking this feasibility analysis important information on ongoing

individual patient outcomes will be presented.

METHODS: Using the Scottish Record Linkage database individual patient adhesion-

related outcomes for all patients undergoing colorectal surgery (open and laparoscopic)

at 6, 12, 18 and 24 months in 1996, 1997 and 1998 have been assessed. These data

has been used to identify the number of hospitals required in a cluster randomisation

population study to demonstrate a reduction in adhesion-related outcomes.

RESULTS: The percentage of adhesion-related readmissions classified as directly-

related for patients undergoing open colon surgery in Scotland in 1996 (n=3192), 1997

(n=3189) and 1998 (n=3214), are as follows;

Approximately 3 out of every 4 directly-related readmissions required reoperation within

12 months. The most common directly-related reoperation was freeing of adhesions.

Details on hospital stays, morbidity and mortality will be presented. The adhesion-

related outcomes following open and laparoscopic surgery will be compared.

Cohort Year% directly adhesion-related readmissions since surgery

6 months 12 months 18 months 24 months

1.21998 2.3 2.7 3.1

1.21997 2.3 2.5 3.1

1.21996 2.1 2.9 3.3


DISCUSSION: This work provides important insight to the impact that colorectal

surgery today has on adhesion-related outcomes and builds on the original work

undertaken in the SCAR study. The variance of adhesion-related readmission rates at a

hospital level has been used to estimate the number of patients and hospital cluster

sites required to progress an outcomes study. It will allow us to confirm the viability of

a population based clinical outcome study.

48

Adhesions – Medicolegal Considerations

49




Adhesion-reduction in high-risk surgery – is there aneed for consensus?

Parker MC.

Adhesions are a major consequence of abdominopelvic surgery that occur in more

than 90% of patients1 and are associated with a high risk of complications, such as

small bowel obstruction and chronic pelvic pain. Surgeons have a duty of care to

educate their patients concerning the risks of post-surgical adhesions to enable them

to make informed decisions regarding treatment.

However, a survey of UK surgical trainees in 2002 showed that only 14% routinely warn

laparotomy patients of the risks of post-surgical adhesions2. Failure to provide such

information can result in claims of negligence.

Since 1995, the UK National Health Services Litigation Authority (NHSLA) has received

57 claims concerning intra-abdominal adhesions, of which half involved urological or

general surgeons. Although an increase in claims has been acknowledged, a survey by

the International Adhesions Society found that adhesions were mentioned during the

consent process in only 10.4% of cases.

A recent consensus in gynaecological surgery recommends that surgeons educate

their patients during the consent process and consider the use of anti-adhesion agents

in high-risk procedures to complement good surgical technique; these strategies were

also recommended in a 1997 general surgery consensus.

The introduction of new and more effective anti-adhesion agents since that date,

together with evidence highlighting the considerable burden of adhesions, suggests

that a new consensus would be of value in general surgery.

References:1. Menzies D, Ellis H. Intestinal obstruction from adhesions-how big is the problem? Ann R Coll

Surg Engl 1990; 72 :60–3.

2. Nash G, Pullen A. Are current surgical trainees preventing future adhesions complications?

Adhesions News & Views 2002; 2: 12.

50

Presented at 30th British Congress of Obstetrics and Gynaecology, Glasgow, 7-9

July 2004

Towards a UK consensus on adhesion reduction

Trew G.

Adhesions are an almost inevitable occurrence following abdominal and pelvic surgery,

whether open or laparoscopic. The impact on daily living for many patients is serious

and can result in small bowel obstruction, infertility, chronic pain and dyspareunia. The

workload and costs to health systems, such as the UK National Health Service, is high.

The most frequently adopted treatment currently is adhesiolysis. An important paradox

is that adhesiolysis is complicated by further traumatic disruption and a high rate of

adhesion reformation (85%) – regardless of the method of adhesiolysis or the type

of adhesion.1

Patients who have had previous surgery have a higher risk of adhesion-related

complications and thus as part of a quality and risk management strategy, patients

should be informed of the risk of adhesions as part of the consent process. However in

a recent international survey adhesions were mentioned in only 10.4% of cases in the

consent process. 54% of patients undergoing an adhesiolysis procedure were given

some information, but only 46% were given specific information about how the

adhesions were to be prevented from re-forming.2 In a recent UK survey of surgical

trainees only, 14% routinely warned patients of the risk of adhesions.3

There is a rise in negligence cases relating to adhesions being reported both to the

Medical Defence Union and the NHS Litigation Authority – where gynaecologists

represented 53% of cases.4 Case law has changed and judges are moving away from

accepting what reasonable doctors might have done, to what reasonable patients

might expect. There is therefore a duty of care to warn patients of all material risks

(generally accepted as >1%) inherent in a proposed procedure.

It is essential to enhance good, safe, medical practice and to reduce the risk of

adverse effects. The use of safe and effective anti-adhesion agents should be

considered in addition to good surgical practice (gentle tissue handling, avoidance of

desiccation, avoidance of intestinal contents and foreign bodies, meticulous

haemostasis and limited use of diathermy or suturing). There are a number of

promising new anti-adhesion agents available and in development with comprehensive

clinical programmes to confirm efficacy.


In the knowledge of the inevitability of postoperative adhesions and their serious

consequences, it is time to ensure patients are advised and steps taken to protect

them, including use of anti-adhesion agents, particularly in surgery known to be at high

risk of adhesion formation, including:

- ovarian surgery

- endometriosis surgery

- tubal surgery

- myomectomy

- adhesiolysis

As surgeons we should be aware that in our increasingly litigious culture that the

consequences of adhesions not only affect patients but could damage our reputation

and career.

Recommendations for management of adhesions recently published should now be

adopted as a national policy and implemented locally to protect patients and surgeons.5

References:1. Diamond MP, Freeman ML. Clinical implications of postsurgical adhesions. Hum Reprod Update

2001; 7: 567–76.

2. Wiseman D. Obtaining informed consent: patient awareness of adhesions. Adhesions News &

Views 2003; 3:10-12.


Adhesions News & Views 2002; 2:12.

4. Ellis H. Medicolegal consequences of adhesions. Hospital Medicine 2004; 65: 348-350.

5. Trew G, Lower A. Consensus in adhesion reduction management. The Obstetrician and

Gynaecologist 2004; 6: S1-16.

52



What will we tell our patients and what will we do?

Parker MC.

Adhesions are an almost inevitable consequence of major abdominopelvic surgery

developing in more than 90% of patients1 and associated with a high risk of post-

surgical complications, such as small bowel obstruction and chronic pelvic pain.

Despite these dangers, a 2002 survey showed that only 14% of UK surgical trainees

routinely warn laparotomy patients of the risks of post-surgical adhesions.2

Surgeons have a duty of care to educate patients concerning the risks of surgery to

enable them to make rational, informed decisions on whether to accept or refuse

treatment. Failure to provide such information can result in claims of negligence

alleging a breach of duty of care resulting in injury. Since 1995, the UK National Health

Services Litigation Authority (NHSLA) has received 57 claims concerning intra-

abdominal adhesions – amounting to £3,790,577 – of which almost half involved

urological or general surgeons.3

Although the increasing incidence of UK negligence claims has been acknowledged,

a survey conducted by the International Adhesions Society found that adhesions were

mentioned as part of the informed consent process in only 10.4% of cases.

Furthermore, only 54% of adhesiolysis patients were given some information prior to

treatment despite the high risks associated with this procedure.4

A consensus recently developed in gynaecological surgery recommends that surgeons

should educate their patients as part of the consent process and should consider the

use of antiadhesion agents to complement good surgical technique, particularly in

high-risk procedures such as adhesiolysis.5 A 1997 general surgery consensus

recognised the need for good surgical practice, and recommended the use of anti-

adhesion adjuvants.6 The introduction of new and more effective anti-adhesion agents

since that date, together with the increasing body of evidence highlighting the

considerable and ongoing burden of adhesions, suggest that a new consensus would

be of great value in general surgery.

There has been no reduction in the incidence of adhesionrelated problems in the last

decade.7 Knowing the high risk of adhesion-related complications following general

surgery, surgeons have a responsibility to advise their patients accordingly. With the

advent of new adhesion-prevention products, surgeons should be encouraged not only

to educate their patients appropriately, but also to consider the use of such agents in


order to stem the increasing incidence of adhesionrelated problems and ensuing

medicolegal claims.

References:1. Menzies D, Ellis H. Intestinal obstruction from adhesions-how big is the problem? Ann R Coll

Surg Engl 1990; 72: 60–3.


Adhesions News & Views 2002; 2: 12.

3. Ellis H. Medicolegal c onsequences of adhesions. Hospital Medicine 2004; 65: 6:1–3.

4. Wiseman D. Obtaining informing consent: patient awareness of Adhesions. Adhesions News &

Views 2003; 4: 10-12.

5. Trew G. Consensus in adhesion reduction management. Obstetrician & Gynaecologist (Lower A,

ed) 2004; 6: 11.

6. Holmdahl L, Risberg B, Beck DE et al. Adhesions: pathogenesis and prevention-panel

discussion and summary. Eur J Surg 1997; 163 (Suppl. 577): 56–62.

7. Sunderland G. SCAR2 – The risk of Adhesions Following Colorectal Surgery. Colorectal Dis

2003; 5: 598. LBA2 (Abstr.).

54

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