research article ligation versus clipping of the ...€¦ · laparoscopic appendectomy is now the...

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Annals of Emergency Surgery Cite this article: Abou-Sheishaa MS, Negm A, Abdelhalim M, Abbas A, Ibrahim M, et al. (2018) Ligation versus Clipping of the Appendicular Stump in Laparo- scopic Appendectomy: A Randomized Controlled Trial. Ann Emerg Surg 3(1): 1029. Central Bringing Excellence in Open Access *Corresponding author Mohamed Samir Abou-Sheishaa, Department of Surgery, Mansoura University, Egypt, Tel: 00201019623935; Email: Submitted: 31 July 2018 Accepted: 16 August 2018 Published: 20 August 2018 Copyright © 2018 Abou-Sheishaa et al. ISSN: 2573-1017 OPEN ACCESS Keywords Laparoscopic; Appendectomy; Clip; Intra-corporeal; Ligature Research Article Ligation versus Clipping of the Appendicular Stump in Laparoscopic Appendectomy: A Randomized Controlled Trial Mohamed Samir Abou-Sheishaa*, Ahmed Negm, Mohamed Abdelhalim, Ashraf Abbas, Mohamed Ibrahim, Hosam Elghadban, and Mohamed Elmetwally Department of Surgery, Mansoura University, Egypt Abstract Background: Laparoscopic appendectomy is now the standard of care for cases of acute appendicitis. It has all the benefits of minimal access surgery like rapid recovery, shorter hospital stay and better cosmetic result. There are many methods for securing the base of the appendix, some of which are expensive; others are not available or technically demanding. In our study we compared between intra-corporeal ligation and metallic clip application for securing the appendicular stump. Aim of the work: Aim of the work was to compare between intra-corporeal ligation and metallic clip application as methods of securing the appendicular stump regarding their safety, simplicity, competence and complications. Patients and methods: We conducted the study in the period between December 2015 and May 2017 in Mansura university hospitals on 80 patients. 40 patients were randomized to metallic clip application (group A) and the other 40 patients to intra-corporeal ligation (group B). Inability to do one technique is considered failure and an indication to do the other. Results: There was failure of the technique in 4 cases of the clip group (group A) 36/40 that were managed by intra-corporeal ligature (group B) 40/40 with p value of 0.12. The mean operative time in group A was 44.8 minutes and 54.6 minutes for group B, P value < 0.05. The mean hospital stay in group A and B was 1.8and1.9 days respectively, P value > 0. 05. No intra- operative complications in both groups. Conclusion: Both techniques of metallic clip application and Intra-corporeal ligation are cost effective in securing the appendicular stump in laparoscopic appendectomy. The only limitation of the clip application is the large diameter of the appendicular stump and in these cases Intra-corporeal ligation can be done. INTRODUCTION The commonest cause of acute abdomen that requires surgical intervention is acute appendicitis. The classical incision used for appendectomy was Grid iron incision which was pioneered by McBurny in the 19th century [1,2]. In the era of minimal access surgery, laparoscopy invades most of the fields of surgery including emergency surgery. Semm, a German surgeon was the first one to do laparoscopic appendectomy in 1983 [3]. In the past, laparoscopic appendectomy didn’t gain the popularity as laparoscopic cholecystectomy because of the higher possibility of postoperative intra-abdominal collection. Also, the methods used for securing appendicular stump were expensive, unavailable or technically demanding. Reports [3,4] have confirmed the safety and feasibility of laparoscopic appendectomy and recommended it as the gold standard for the management of acute appendicitis. All the benefits of minimal access surgery like (less post- operative pain, shorter hospital stay, better cosmetic result and rapid recovery) are strongly present in laparoscopic appendectomy. Another major advantage is the diagnostic laparoscopy, done initially in any case of acute abdomen and is very helpful in doubtful cases especially in females. Various techniques have been used for securing the appendicular stump, some of which is expensive as endoscopic linear cutting stapler (Endo-GIA) [5,6]; others are not available in some hospitals as preformed suture loops (endoloops). Base control also has been tried by metallic clips but not on a

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Page 1: Research Article Ligation versus Clipping of the ...€¦ · Laparoscopic appendectomy is now the standard of care for cases of acute appendicitis. It has all the benefits of minimal

Annals of Emergency Surgery

Cite this article: Abou-Sheishaa MS, Negm A, Abdelhalim M, Abbas A, Ibrahim M, et al. (2018) Ligation versus Clipping of the Appendicular Stump in Laparo-scopic Appendectomy: A Randomized Controlled Trial. Ann Emerg Surg 3(1): 1029.

CentralBringing Excellence in Open Access

*Corresponding authorMohamed Samir Abou-Sheishaa, Department of Surgery, Mansoura University, Egypt, Tel: 00201019623935; Email:

Submitted: 31 July 2018

Accepted: 16 August 2018

Published: 20 August 2018

Copyright© 2018 Abou-Sheishaa et al.

ISSN: 2573-1017

OPEN ACCESS

Keywords•Laparoscopic; Appendectomy; Clip; Intra-corporeal;

Ligature

Research Article

Ligation versus Clipping of the Appendicular Stump in Laparoscopic Appendectomy: A Randomized Controlled TrialMohamed Samir Abou-Sheishaa*, Ahmed Negm, Mohamed Abdelhalim, Ashraf Abbas, Mohamed Ibrahim, Hosam Elghadban, and Mohamed Elmetwally Department of Surgery, Mansoura University, Egypt

Abstract

Background: Laparoscopic appendectomy is now the standard of care for cases of acute appendicitis. It has all the benefits of minimal access surgery like rapid recovery, shorter hospital stay and better cosmetic result. There are many methods for securing the base of the appendix, some of which are expensive; others are not available or technically demanding. In our study we compared between intra-corporeal ligation and metallic clip application for securing the appendicular stump.

Aim of the work: Aim of the work was to compare between intra-corporeal ligation and metallic clip application as methods of securing the appendicular stump regarding their safety, simplicity, competence and complications.

Patients and methods: We conducted the study in the period between December 2015 and May 2017 in Mansura university hospitals on 80 patients.

40 patients were randomized to metallic clip application (group A) and the other 40 patients to intra-corporeal ligation (group B). Inability to do one technique is considered failure and an indication to do the other.

Results: There was failure of the technique in 4 cases of the clip group (group A) 36/40 that were managed by intra-corporeal ligature (group B) 40/40 with p value of 0.12.

The mean operative time in group A was 44.8 minutes and 54.6 minutes for group B, P value < 0.05.

The mean hospital stay in group A and B was 1.8and1.9 days respectively, P value > 0. 05. No intra- operative complications in both groups.

Conclusion: Both techniques of metallic clip application and Intra-corporeal ligation are cost effective in securing the appendicular stump in laparoscopic appendectomy. The only limitation of the clip application is the large diameter of the appendicular stump and in these cases Intra-corporeal ligation can be done.

INTRODUCTIONThe commonest cause of acute abdomen that requires surgical

intervention is acute appendicitis. The classical incision used for appendectomy was Grid iron incision which was pioneered by McBurny in the 19th century [1,2].

In the era of minimal access surgery, laparoscopy invades most of the fields of surgery including emergency surgery. Semm, a German surgeon was the first one to do laparoscopic appendectomy in 1983 [3].

In the past, laparoscopic appendectomy didn’t gain the popularity as laparoscopic cholecystectomy because of the higher possibility of postoperative intra-abdominal collection. Also, the methods used for securing appendicular stump were expensive, unavailable or technically demanding.

Reports [3,4] have confirmed the safety and feasibility of laparoscopic appendectomy and recommended it as the gold standard for the management of acute appendicitis.

All the benefits of minimal access surgery like (less post-operative pain, shorter hospital stay, better cosmetic result and rapid recovery) are strongly present in laparoscopic appendectomy.

Another major advantage is the diagnostic laparoscopy, done initially in any case of acute abdomen and is very helpful in doubtful cases especially in females.

Various techniques have been used for securing the appendicular stump, some of which is expensive as endoscopic linear cutting stapler (Endo-GIA) [5,6]; others are not available in some hospitals as preformed suture loops (endoloops).

Base control also has been tried by metallic clips but not on a

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Abou-Sheishaa et al. (2018)Email:

Ann Emerg Surg 3(1): 1029 (2018) 2/6

CentralBringing Excellence in Open Access

large scale, the problem of the technique of metallic clips is that some surgeons are not confident with its safety.

In our study, we compared between the intra- corporeal ligation of the appendicular stump and the metallic clips, as regard safety, competence, applicability, cost and specific complications related to each.

PATIENTS AND METHODSDuring the period from December 2016 to May 2018 in

Mansura university hospitals (Recovery hospital and Main hospital), 80 patients were included in this randomized prospective study.

All patients were consented before being included in the study. The study was approved by local ethics and research committee of Mansoura faculty of medicine Table 1,2.

The patients were randomly distributed into 2 groups

Group A: Metallic Clip group (MC Group).

Group B: Intra corporeal ligation group (ICL Group)

Group B is further subdivided into 2 subgroups:

B1: Devascularization first subgroup

B2: Ligation firs subgroup

Method of randomization was by the following orderCase no. 1: clip group

Case no. 2: devascularization first subgroup

Case no. 3: clip group

Case no. 4: ligation first subgroup

Inability to apply any of the techniques is considered failure and the other technique is attempted.

Primary objectiveTo compare between clipping and ligation regarding safety

and complications.

Secondary objective • To Compare between both techniques of ICL

(devascularization first versus ligation first).

• And to compare the simplicity of the techniques for trainees.

Inclusion criteriaAll cases of acute appendicitis that were subjected to

laparoscopic appendectomy were included in the study.

Exclusion criteria1-Appendicular mass which was diagnosed either by

ultrasound or by examination under anesthesia were excluded of the study.

2- Cases with perforation at the base.

All patients were subjected to classic history taking, examination and investigations.

Laboratory investigations Complete blood count, Liver functions and renal function

Radiological investigationsUltrasonography was routinely done for all patients to help

in confirmation of the clinical diagnosis and also helps in the diagnosis of complications like mass or abscess which were considered exclusion criteria; CT with oral and intravenous contrast was requested in case of suspicion of complications that were not diagnosed definitely by ultrasound.

Before surgery, all patients were examined under general anesthesia and if a mass was felt, the case was excluded from the study.

All patients received 1gm of ceftriaxone at the time of induction of anesthesia. Another dose of 500 mg metronidazole was added in case we found perforated appendix.

All patients received below knee elastic stock as prophylaxis against DVT.

All patients were asked to evacuate urinary bladder before surgery; no Foley’s catheter was routinely inserted.

Criteria of discharge of the patient from the hospital• Absence of fever

• Good tolerance of oral diet

• Removal of the drain if was inserted

The patients were followed up for 6 months

Surgical techniquesWe used 3 ports; the first (optic port, 12mm) was inserted

under vision by the open method just above the umbilicus. We used 30° telescope.

The second port (12mm) was inserted in the left iliac fossa through which we inserted a non-traumatic grasper to do manipulation of viscera to perform diagnostic laparoscopy. The other working port (5mm) was inserted either in the supra-pubic region in subgroup B1 or in the right hypochondrium in subgroup B2.

The patient was put in the Trendlenburg position with tilt to left to facilitate the exposure of the caecum and appendix.

Any free fluid or collections were aspirated at first.

The first step was devascularization in clip group and devascularization first subgroup.

Devascularization was done by hook or Maryland connected to monopolar diathermy (Figure 1,2).

Dissection was done in close proximity to the wall of the appendix. This has 2 advantages; one is less bleeding because the plane between the appendix and the meso-appendix is loose areolar tissue and the second is easy retrieval of the appendix after its excision (Figure 3).

The first step in ligation first subgroup is to make a window in the meso-appendix near the base and pass a ligature of Vicryl (polyglactin) 0 and perform 3 knots ;2 proximally and one distally and cut in between (Figure 4).

The second step in clip group or devascularization first subgroup was to ligate the base by 3 knots Vicryl (polyglactin) 0 by intra-corporeal knotting technique: two proximally and one

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Abou-Sheishaa et al. (2018)Email:

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Table 1: Characteristics and outcomes of both techniques.Group A (MC)

(n= 36)Group B (ICL)

(n= 44) P valueNo. % No. %

SexMale 12 33.3 14 31.8 0.8855

Female 24 66.7 30 68.2Age (years)

Mean age 33.25 years 36.60 years 0.468Condition of the base:

Normal 10 27.8 15 34Edematous 15 41.7 18 40.9 0.735994Hyperemic 3 8.3 5 11.4

Friable 8 22.2 6 13.7Gross pathology of the appendix:

Appendix grossly normal 3 8.3 5 11.4 0.653095Appendix grossly abnormal 33 91.7 39 88.6

Mean operation time 44.75 min. 54.56 min. < 0.00001*

Mean hospital stay 1.78 day 1.89 day 0.797309Simplicity to trainee ++++ ++ -

Mean cost 74.71 $ 72.31 $ 0.145533P: p value for comparing between the two groups; *: Statistically significant at p ≤ 0.05

Table 2: Comparison between the devascularization 1st sub group and ligation 1stsubgroup.

Devascularization 1st subgroup Ligation 1st subgroup P value

No. 24 20 -

Mean operative time 59.2 min. 50.9 min. 0.000627*Simplicity of the technique for

trainee ++ +++ -

P: p value for comparing between the two groups; *: Statistically significant at p ≤ 0.05

Table 3: Comparison of the 2 groups according to complicationsClips

(n=36)ICL

(n=44)No. % No. %

Intestinal injury 0 0% 0 0%Ileus 1 2.8% 3 6.8%

Conversion rate 0 0% 0 0%Fistula 0 0% 0 0%

Abdominal abscess 1 2.8% 0 0%Port site infection 2 5.56% 1 2.27%

Failure of technique 4 11.1% 0 0%Re-admission 1 2.8% 0 0%Re-operation 0 0% 0 0%

distally and cut in between; or clip it by 3 clips (medium or large according to diameter of the base) (Figure 5).

The second step in ligation first subgroup was devascularization of the meso-appendix by hook connected to monopolar diathermy in close proximity to the wall of the appendix.

Cautery of the mucosa of the appendicular stump was done to all cases (Figure 6,7).

Most of cases were done by consultants of surgery in our hospital but there were only 5 cases in each group that were

performed by the trainees under supervision.

The abdominal cavity was finally searched for any collections or bleeding. No drains were inserted except in cases of perforated appendix.

The appendix was retrieved through the port of the left iliac fossa and sent routinely to histo-pathological examination (Figure 8).

The overall average cost was calculated for each technique after each operation without surgeon fees.

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There was an operative sheet including the gross appearance of the appendix and the condition of the base filled by the surgeons:

• Normal

• Hyperemic

• Edematous

• Friable

Another operative sheet for the simplicity of the technique was filled by the juniors (trainees).

Statistical method: The collected data were coded, processed and analyzed using the SPSS (Statistical Package for Social Sciences) version 21 for Windows® (SPSS Inc., Chicago, IL, USA). Qualitative data was presented as number and percent. Comparison between groups was done by Chi-Square test. Student t-test, Mann-Whitney U test and Fischer exact test were used to compare between two groups. P value<0.05 was considered to be statistically significant.

Figure 1 Devascularization of appendix using hook connected to monopolar diathermy.

Figure 2 Devascularization of appendix using Maryland connected to monopolar diathermy.

Figure 3 Making a window in the meso-appendix.

Figure 4 Ligation of the base of the appendix.

Figure 5 2 knots ligation of the base of the appendix.

Figure 6 Clipping of the appendicular stump by 2 clips and distal appendix by one clip.

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RESULTSInitially, 85 patients were selected to be included in the study

but 5 patients were excluded, three of them because a mass was felt after giving muscle relaxant and the other 2 cases because there were perforation at the base of the appendix.

So, actually 80 patients were included in the study, who were randomly distributed into 2 groups, 40 for each group.

For ICL group the patients were further divided into 2 subgroups

-B1: (devascularization first) 20.

-B2: (ligation first) 20

There was failure of the technique in 4 cases of the clip group so ICL was done for these 4 cases , the cause was large diameter of the base of the appendix that can’t be secured by even large clips. So the MC group was 36 (36/40) and ICL group was 44 patients (40/40). (P value was 0.12) Table 3.

The mean age was 33.25 years in group A and 36.60 in group B.

The mean operative time in group A was 44.75 minutes and 54.56 minutes in group B (p value<0.05). The mean hospital stay was 1.8 day in group A and 1.9 day in group B (p value>0.05).

The ICL technique was successful in all cases (100%) while clip was successful in 36 cases where it failed in 4 cases (90%).

There were no intra-operative complications in both groups (such as access complications or intestinal injury).

Average all cost of the operation in group A was 74.71$ while 72.31$ in group B without the fees of the surgical team.

Post-operative complications of group A • 2 cases (5.5%) had port site infection.

• 1 case (2.8%) had ileus for 72 hours that improved by conservative measures.

• 1 case (2.8 %) developed post-operative collection that was discovered during follow up in outpatient clinic for which ultrasound guided tube drainage was done.

Group B• 1case (2.3%) had port site infection.

• 3 cases developed ileus that passed smooth with conservative measures.

DISCUSSIONThe popularity of laparoscopic appendectomy is increasing

among surgeons by time [6]. The advantages of laparoscopic surgery such as, shorter recovery, less post-operative pain and better cosmetic results are strongly present in laparoscopic appendectomy.

The other major advantages of laparoscopic appendectomy are the diagnostic laparoscopy done before delivery of the appendix and lower rate of wound infection.

Most cost studies have confirmed the higher cost of lap appendectomy in comparison to open appendectomy due to the cost of instruments during the procedure [7,8].

One of the important causes of higher cost is the instrument or tools used for securing the base.

Different methods were used to secure the base during laparoscopic appendectomy including the use of Endo-GIA which is expensive, Endo loop which is also relatively expensive and not available in many hospitals in our country. Other methods include metallic clips, polymeric clips and intra-corporeal suture ligation which are less in cost.

Sahm and his colleagues confirmed, in their study that intra-corporeal ligation is a safe alternative for the expensive linear stapler or less expensive endoloop and show no significant difference in safety and efficacy [6].

In another study by Kiudelis and his colleagues [9], reported that intra-corporeal ligation is a safe method, and cheaper than endolooptechnique. Compared with laparoscopic staplers end loops have an advantage as they are 6 to 12 times cheaper than stapling device [10], this was matching with our study since no major complications occurred with intra-corporeal ligation, the cost of course is less because we just used 1 ampoule of polyglactin0 which might be used to close the port site as well in many cases, one other advantage of intra-corporeal ligation is its applicability in all cases.

As commercially available titanium and absorbable clip can sustain a high degree of intraluminal pressure and cannot be displaced by a pressure of 300 mmHg [11], and are lower in cost, their use is acceptable for securing the appendicular stump like the cystic duct.

Rickert and co-workers [12], used a titanium double shanked clip in their study which was able to secure appendicular base up to 2 cm safely.

This was different from our study because we used the ordinary medium large or large clip which cannot secure 2 cm

Figure 7 Cauterization of the appendicular mucosa.

Figure 8 Retrieval of the appendix after its disconnection.

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Abou-Sheishaa MS, Negm A, Abdelhalim M, Abbas A, Ibrahim M, et al. (2018) Ligation versus Clipping of the Appendicular Stump in Laparoscopic Appendectomy: A Randomized Controlled Trial. Ann Emerg Surg 3(1): 1029.

Cite this article

diameter, the other major disadvantage reported by Rickert and his colleagues was the need for 12 mm port for introduction of clip applier. We do not consider it major drawback for using clips because most of surgeons will need this port for retrieval of the appendix; others use the telescope port for retrieval which is difficult and time consuming in some cases.

Our study matched with results of other studies [13-15], that using metallic clips for appendicular stump closure is safe and associated with less operative time in laparoscopic appendectomy. It also makes the procedure simpler and provides a useful alternative of intra-corporeal ligation.

We used monopolar diathermy with caution to cauterize the mucosa of the appendicular stump because the fluid emerging of the stump is potentially contaminated and this may be related to increased possibility of surgical site infection. This was inspired from a study by Ahmad and his colleagues [16], which revealed that cautery of appendicular mucosa is 100% effective in sterilization of the appendicular stump.

We did not use commercial endobag routinely for retrieval of the appendix because they are expensive and not available in our hospital, in most of cases we retrieved the appendix through 12mm cannula to and extract them together to prevent contact between infected appendix and porte site but actually contact happens in some cases during manipulation. The cause of this was the large diameter of the appendix that made it difficult to be included inside the cannula. This explains the port site infection that happened in 3cases out of 80 (3.8%). Fortunately infections were mild and managed by simple drainage and a short course of antibiotic. In a study by Hansen and his colleagues [17], the incidence of port site infection was 2% which was lower than our study. Simply this can be attributed to endobags used in Hansen study. No doubt, the use of commercially available endobag will decrease the possibility of port site infection but its cost is the main obstacle for its routine use. The formation of endobag from sterilized glove is a good alternative with lower cost.

CONCLUSION Both methods of ICL and clip application are cost effective in

securing the appendicular stump.

The only limitation of the clip application is the wider diameter of the base of the appendix beyond the large titanium clip in these cases intra-corporeal ligation is a safe and cheap alternative.

The technique of the ligation first can be applied in selected cases where the anatomy is clear from the start while the devascularization first technique can be done in all cases.

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