reducing trocar movement in operative laparoscopy through use of a fixator
TRANSCRIPT
Original Article
Reducing Trocar Movement in Operative Laparoscopy through Useof a Fixator
Vasileios Vrentas, Anja Herrmann, Cristina Cezar, Garri Tchartchian, MD, Patrick Diesfeld, MD,and Rudy Leon De Wilde, MD, ScD, PhD*From Carl von Ossietzky University, Department of Obstetrics and Gynecology, Pius-Hospital, Oldenburg, Germany (all authors).
ABSTRACT Study Objective: To evaluate trocar stability using a fixation device to control trocar insertion depth and in particular to
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provide greater stability during laparoscopic procedures, and to evaluate the effects of using a fixator to control mobilityof trocars.Design: Non-blinded prospective study (Canadian Task Force classification II-2).Setting: University hospital department of gynecology, obstetrics, and gynecological oncology.Patients: Forty-three patients scheduled to undergo gynecologic laparoscopic intervention with planned operative time.10 minutes.Interventions: In all procedures, 5-mm working trocars bearing a plain (smooth) sleeve were used. The fixator device, con-secutively either on the left or right side, was attached to 1 of 2 side trocars before insertion. In 18 patients, an unsutured fixatorwas used (FX-US subgroup). In the remaining 25 patients, the device was sutured to the skin via specially designed suturingports (FX-S subgroup). The position of both trocars in the groups with a fixator (FX group) and without a fixator (NFX group)in the abdominal wall was evaluated at the start of the procedure and every 10 minutes intraoperatively.Measurements and Main Results: In the FX group, there was significantly decreased trocar movement compared withthe NFX group (mean [SD] 0.02 [0.6] cm vs 0.84 [4.4] cm). In addition, in the NFX group, the trocar tended to slip intothe abdomen during the operation, whereas in the FX group, trocars tended to slip out. Of 43 ports, 11 (25.6%) had to be eitherreinserted or readjusted at some point during the operation. In 2 procedures, reinsertion of the trocar at exactly the samelocation was impossible. In the FX-US subgroup, there was 1 incidence of trocar dislocation, whereas there were no disloca-tions in the FX-S subgroup. The difference in the effect between the 2 study arms, fixator unsutured and fixator sutured, wasexpected to produce only a small benefit in the sutured fixator arm; however, the benefit was greater than anticipated.Conclusion: Use of a fixator significantly reduces plain (smooth) sleeve trocar movement and prohibits complete dislocationor slippage of the port, and suturing the device to the skin further minimizes trocar movement. Trocar stabilization via a fix-ation device may lead to shorter operative time and reduce problems associated with trocar slippage or dislocation. Journal ofMinimally Invasive Gynecology (2013) 20, 842–847 � 2013 AAGL. All rights reserved.
Keywords: Laparoscopy; Trocar fixation; Trocar injury; Trocar insertion; Trocar movement
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thor: Prof. Rudy Leon De Wilde, Carl von Ossietzky Uni-
nt of Obstetrics and Gynecology, Pius-Hospital, Georgstr
121, Germany.
7, 2013. Accepted for publication May 2, 2013.
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Laparoscopic surgery has been of immense benefit toboth patients and healthcare systems [1].Trocar insertionand stability of the port during the operation is a commonproblem in laparoscopy. Trocar dislocation, requiring read-justment, complete removal with loss of pneumoperitoneum,and reinsertion, is inconvenient and cannot be managedonly with more experience. Multiple attempts at trocar fixa-tion (e.g., rubber ring, fascia sutures with Hasson trocars,additional fascia sutures, built-in abdominal wall anchoring
Fig. 1
Laparoscopic procedures in trocar movement study in 43 patients.
Vrentas et al. Reducing Trocar Movement Using a Fixator 843
devices in disposable trocars) have been used in thelast 20 years and have positive as well as negative ef-fects [2–5]. Complications related to laparoscopic portdesign and the common problem of port dislodgement ledto invention of an anchoring mechanism for trocarplacement, a fixator, that assists in controlling trocarinsertion depth and stabilizes the port in the abdominalwall during the procedure [6]. To maximize stability, thefixator can be sutured to the skin through 3 possible suturingholes. The use of this fixator has resulted in significantlylower operative time due to fewer interruptions in thesurgical intervention [6], it can have a time-sparing effectby averting trocar manipulation, and it increases surgeon
Fig. 2
Trocar movement in 10-minute intervals during the operation. In the FX-US subg
ment, whereas in the NFX group (no fixator), there was a tendency for intra-ab
satisfaction because of a smoother operative course. Dataon the effects of using a fixator to control trocar movementin gynecologic laparoscopic surgery are rare. Therefore,the present study was performed to evaluate trocar mobilityas well as trocar dislocation and slippage.
Material and Methods
This non-blinded prospective study included 43 consecu-tive patients undergoing gynecologic laparoscopic surgery atour institution between April and July 2011. All patients in-cluded provided informed consent. The fixator has a CEmark for Europe (Conformit�e Europ�eenne). Patients wereconsidered eligible for inclusion in the study if scheduledlaparoscopic operative timewas.10 minutes. The operativegynecologic procedures performed are shown in (Fig. 1).Because longer procedures usually require more instrumentchanges, the influence on trocar movement was documentedin a time-dependent manner (Fig. 2).
Pyramidal-tipped, 5-mm, bladed trocars with a plain(smooth) metallic sleeve (Karl Storz GmbH & Co. KG, Tut-tlingen, Germany), frequently used in Europe, were used inall patients. The fixator was attached to 1 of 2 secondary tro-cars before insertion, thus creating the 2 major comparisongroups: the FX group (trocar with a fixator) and the NFXgroup (trocar without a fixator).
The fixator (Laprostop; Innovamed, Inc., Ventura, CA)consists of 3 components: a triangular flange of transparentplastic to stabilize the port at the abdominal wall at a certaindepth, a plastic nut fitted to the port, and a rubber ring tofurther stabilize the flange to the port. The 3 edges of theflange have suturing holes, which provide the option of
roup (unsutured fixator), there was a tendency for extra-abdominal move-
dominal movement (deeper in the abdominal cavity).
844 Journal of Minimally Invasive Gynecology, Vol 20, No 6, November/December 2013
suturing the flange to the skin [6]. The fixator is illustratedin (Fig. 3).
Placement of both trocars in the abdominal wall was eval-uated beginning immediately after insertion of the secondarytrocars to the abdominal wall and thereafter every 10 min-utes during the operation. In 18 patients, an unsutured fixatorwas used (FX-US subgroup), and in the remaining 25 pa-tients, the device was sutured on 3 of 3 specially designedsuturing holes (FX-S subgroup). After previous experiencein our clinic [6], we determined that only 2 fixation suturesseemed sufficient for the present study. The contralateral tro-car served as a control (NFX group).
The ports were used in all operations by one surgeon,who was experienced in laparoscopy, have performed.1000 procedures. The position at the operating table wasidentical in all procedures, with the surgeon standing onthe left side of the patient and the assistant on the right.The same set of instruments was used over the same opera-tive time in all patients. Positioning of ports, angle of open-ing the fascia, and height of the operating table werestandardized in all patients. The secondary trocars wereplaced at the same position in all patients, at the left andright side of the pelvic abdomen, lateral to the epigastric ves-sels. Depending on patient size, height, and weight, smalldifferences could potentially occur; we expected these fac-tors to be reflected in the body mass index (BMI) measure-ment. The skin incision was always ,1 cm. The fascia wasnot opened via incision but by using the trocar tip at a stan-dardized angle of 90 degrees. The optic trocar was placed
Fig. 3
Graphic illustrations of the Laprostop fixator (Innovamed) shows inte-
gral components: 1 5 Collet (medical-grade vinyl), 2 5 cannula,
3 5 base with suture holes and adhesive, 4 5 trocar blade, 5 5 trocar,
and 6 5 wing nut (non-galling nylon).
conventionally in the umbilical area. Because there was con-tinuous change of instruments used through both secondaryports, the position of the fixation device on the right orthe left side was changed in every other patient. Thus, theeffect of handedness of the surgeon was excluded insofaras possible.
Fixation of the trocars was evaluated by measuring thedistance between the upper end of the port to the skin.Any decrease in the measured distance indicated that the tro-cars were moving intraabdominally, deeper in the abdomen,whereas any increase showed that they were moving extra-abdominally. Complete trocar dislocation was defined asdisappearance of the port tip from the intraperitoneum tothe retroperitoneum.
Statistical Analysis
The Wilcoxon signed-rank test for 2 related samples(2 measurements per patient), 1 in the FX group and 1 inthe NFX group, was used to determine whether use of thefixator influenced trocar movement. To investigate whetheroverall movement was reduced, a 1-sided hypothesis testwas used. The Mann-Whitney U test was used to furtherinvestigate mean subgroup differences (FX-S vs FX-USsubgroups). All differences were considered significantat p , .05. Statistical analysis was performed using theR programming language.
Results
Both overall movement distance and movement variance(mean [SD]) were significantly decreased in the FX groupcompared with the NFX group (0.02 [0.6] cm vs 0.84[4.4] cm; p 5 .01 and p 5 .006, respectively) (Fig. 4).
Fig. 4
Trocar movement in NFX group was significantly greater than in the FX
group (p 5 .006 and p 5 .01, respectively).
Fig. 5
Movement distance and movement variation were greater in the NFX
group than in the FX-US and FX-S subgroups. Mobility variance was
significantly decreased in the FX-S subgroup compared with the FX-
US subgroup (p 5.001).
Fig. 6
Trocar movement in the FX group with the fixator in place on the left
(A) or right (B) side. No significant side-related differences were ob-
served.
Vrentas et al. Reducing Trocar Movement Using a Fixator 845
Furthermore, the FX-S-subgroup showed a significantdecrease of mobility variance compared with the FX-US-subgroup (p 5.001) (Fig. 5).
No significant difference in movement distance betweenthe left and right sides was found in either the FX or the NFXgroup (0.38 [3.9] cm vs 0.48 [1.2] cm; p 5 .10, Mann-Whitney U test) (Fig. 6).
Use of a fixator resulted in significantly decreased trocarmobility regardless of direction (intraabdominally or extra-abdominally). In the NFX group there was a tendency forintra-abdominal, deeper in the abdominal cavity, movementduring surgery, whereas in the FX-US subgroup there wasa tendency for extra-abdominal movement (Fig. 2). Of43 ports, 11 (25.6%) in the NFX group had to be either rein-serted or readjusted at some point during the operation.Complete trocar dislocation occurred in 4 of the 11 proce-dures, and the trocar had to be completely reinserted. During5 procedures, the entire tube of the port slipped into the ab-domen 1 to 3 times and had to be readjusted. In the other2 procedures, the trocar could not be reinserted at the samesite in the abdominal wall because the port was destabilizedat every attempt at instrument insertion due to tearing andwidening of the fascia. In the FX-US subgroup, there wasone incidence of complete dislocation, probably due to obe-sity (BMI, 35.74), and the trocar had to be reinserted to theintra-abdominal position at minute 8 of the operation. BMIof all patients was documented and considered in relationto trocar movement (Fig. 7).
No infection or cosmetic problems occurred at the suturesites.
Discussion
Easy-access surgery has contributed positively in dimin-ishing complications of invasive open surgical procedures
[7]. Trocar insertion is associated with a variety of problemsincluding vascular and visceral injuries, abdominal wall he-matoma, postoperative trocar site hernias, and trocar sitepain [8,9]. Other than injuries occurring at initial entry,which have been estimated to account for half of the thoseoccurring during laparoscopy [10], several injuries may oc-cur intraoperatively, during secondary entry [11]. Varioustypes of trocars have been investigated in terms of associatedrisk of injury at initial insertion and/or intraoperatively.Compared with trocars with a dilating tip, non-shieldedbladed trocars are said to be easier to place and to result ina smaller rate of displacement [12]. Compared with 5-mmtrocars, 3-mm ancillary trocars seem to reduce incisionpain after laparoscopy, although they do not reduce operativetime or intraoperative complications [13]. Blunt trocars arethought to be associated with substantially greater stabilityand fixation of the port to the abdominal wall [14].
Intraoperative dislodgement of port systems complicatesthe effectiveness of laparoscopy. Desufflation of the abdo-men and subcutaneous emphysema are 2 sequelae of portdislodgement, in addition to disadvantages due to prolonga-tion of the surgical procedure. Hence, trocar stability may becrucial in further reducing trocar-related laparoscopic com-plications. In a recent study from our department [6] thatcompared 3 different access systems (trocar with spiralthread sleeve, trocar with plain [smooth] sleeve, and trocarwith plain sleeve with a fixator), we observed that wall an-choring components led to higher stability of ports, whichled to reduced mean operative time.
In the present study, 1 in 4 ports without fixation was atsome point during the operation either completely or
Fig. 7
Trocar movement in correlation with patient body mass index (BMI).
846 Journal of Minimally Invasive Gynecology, Vol 20, No 6, November/December 2013
partially dislocated or slipped completely into the abdomen,with no adherence to the abdominal wall or the fascia, andhad to be either reinserted or readjusted. Using the fixator,we observed only 1 incidence of complete port dislocation,which occurred in an obese patient. Dislodgement of trocarsoccurs more frequently in obese patients [12], and obesity isalso associated with higher potential risk of injury due tomisplacement [15]. In addition, in obese patients, incisionsmay be longer, operative time may be prolonged, and riskof port displacement may be increased [16]. In our only in-cidence of dislocation using a fixator in the FX-US subgroup(the length of the port tube that can enter the abdominal wallis reduced by the height of the fixator), the port had to be in-serted to maximum depth, without, however, occurrence offurther dislocations or other difficulties during the remainderof the procedure.
Insofar as placement of the fixator on the left or right side,the choice of use of an unsutured or a sutured fixator was notmade consecutively. In the first 18 patients, an unsutured fix-ator was used (FX-US subgroup), and in the remaining 25patients, a sutured fixator was used (FX-S subgroup). Timeto connect the fixator could possibly have been a factorthat prolonged operative time; however, in the present study,fixator placement was performed rapidly, without substan-tially delaying initial entry. In the present study, the time de-lay in the FX-S subgroup compared with the FX-USsubgroup, related to fixation of the trocar to the skin, was,1 minute.
Insofar as the economic aspects, there were positive andnegative influences. The expense and application time ofthe device can be put in relation to the already knowntime-saving effect [6] and the reduced complete dislocationrate documented in the present study, bringing an extra pos-itive time element. In all patients, 5-mm ports were used;thus, the results of our study are limited to this port size.The documented results could have been even more signifi-cant with use of larger ports; however, this aspect needs to befurther investigated.
Surgeons performing laparoscopy without the assistanceof a fixator may face various challenges such as inversion
and scaling of movements, altered sensation of forces, andfriction at the incision site [2]. Light stiffness of the fixatedtrocar due to the larger surface of the triangular flange oc-curred in the FX group, parallel to the patient surface. How-ever, this subjective feeling needs to be further investigatedto fully elucidate the potential effect on haptic sensation ofthe surgeon performing laparoscopy. The present studywas non-blinded; although surgery was performed by thesame and only experienced gynecologic laparoscopist,a change in performance intraoperatively, with a resultingbias, cannot be completely excluded.
Important complications did not occur in the presentstudy, probably because of the small number of patients in-cluded. Further comparative studies could eventually be use-ful to examine whether fixators may provide more patientsafety when used by young and inexperienced or less confi-dent surgeons and residents. Through fixation of the port ata certain distance from the trocar tip before insertion, addi-tional safety in inserting the trocar into the abdominal wallcan be obtained by lowering the risk of trocar-associated in-juries at initial entry.
In conclusion, use of a fixator reduces mobility and there-fore port dislocation and slippage, resulting in a more com-fortable operating procedure and potentially a shorteroperative time. Continuous slippage of the trocars due tomovement of the instruments, a common frustrating problemin laparoscopy and a cause of time loss, was minimized inthe present study. Furthermore, suturing the fixator to theskin, a rapid and complication-free procedure, results in fur-ther substantial reduction in movement of ports.
References
1. Korolija D, Sauerland S, Wood-Dauphin�ee S, et al. European Associa-
tion for Endoscopic Surgery. Evaluation of quality of life after laparo-
scopic surgery: evidence-based guidelines of the European Association
for Endoscopic Surgery. Surg Endosc. 2004;18:879–897.
2. Westebring-van der Putten EP, Goossens RH, Jakimowicz JJ,
Dankelman J. Haptics in minimally invasive surgery: a review. Minim
Invasive Ther Allied Technol. 2008;17:3–16.
3. Bax NM, van der Zee DC. Trocar fixation during endoscopic surgery in
infants and children. Surg Endosc. 1998;12:181–182.
Vrentas et al. Reducing Trocar Movement Using a Fixator 847
4. Metzelder ML, Ure BM. Fascial fixation of sleeved trocar prevents tro-
car dislocation and allows adjustment in pediatric laparoscopy. J Lapa-
roendosc Adv Surg Tech A. 2007;17:276.
5. Mill�an C, Bignon H, Buela E, et al. A simple way to fix a trocar during
pediatric laparoscopy. J Pediatr Surg. 2011;46:601–603.
6. Tchartchian G, Dietzel J, Surrey MW, Dewilde RL, Bojahr B. Saving
time during laparoscopy using a new, wall anchoring trocar device.
JSLS. 2010;14:196–199.
7. Velanovich V. Laparoscopic vs open surgery: a preliminary comparison
of quality-of-life outcomes. Surg Endosc. 2000;14:16–21.
8. Bhoyrul S, Vierra MA, Nezhat CR, Krummel TM, Way LW. Tro-
car injuries in laparoscopic surgery. J Am Coll Surg. 2001;192:
677–683.
9. Larobina M, Nottle P. Complete evidence regarding major vascular in-
juries during laparoscopic access. Surg Laparosc Endosc Percutan
Tech. 2005;15:119–123.
10. Vilos GA, Vilos AG, Abu-Rafea B, Hollett-Caines J, Nikkhah-
Abyaneh Z, Edris F. Three simple steps during closed laparoscopic en-
try may minimize major injuries. Surg Endosc. 2009;23:758–764.
11. Merlin TL, Hiller JE, Maddern GJ, Jamieson GG, Brown AR, Kolbe A.
Systematic review of the safety and effectiveness of methods used to es-
tablish pneumoperitoneum in laparoscopic surgery. Br J Surg. 2003;90:
668–679.
12. Stepanian AA, Winer WK, Isler CM, Lyons TL. Comparative analysis
of 5-mm trocars: dilating tip versus non-shielded bladed. J Minim Inva-
sive Gynecol. 2007;14:176–183.
13. Ghezzi F, Cromi A, FasolaM, Bolis P. One-trocar salpingectomy for the
treatment of tubal pregnancy: a ‘marionette-like’ technique. BJOG.
2005;112:1417–1419.
14. Hamade AM, Issa ME, Haylett KR, Ammori BJ. Fixity of ports to the
abdominal wall during laparoscopic surgery: a randomized comparison
of cutting versus blunt trocars. Surg Endosc. 2007;21:965–969.
15. Pemberton RJ, Tolley DA, van Velthoven RF. Prevention and manage-
ment of complications in urological laparoscopic port site placement.
Eur Urol. 2006;50:958–968.
16. Rabl C, Palazzo F, Aoki H, Campos GM. Initial laparoscopic access us-
ing an optical trocar without pneumoperitoneum is safe and effective in
the morbidly obese. Surg Innov. 2008;15:126–131.