ORIGINAL ARTICLE

Single-Incision Laparoscopic Cholecystectomy: Will it Succeed as the Future Leading Technique for Gallbladder Removal? Thomas Resch, MD, Robert Sucher, MD, Alexander Perathoner, MD, Elisabeth Laimer, MD, Elisabeth Mohr, MD, Johann Pratschke, MD, and Reinhard Mittermair, MD

Background: The quest for less traumatic abdominal approaches is changing paradigms in times of minimally invasive surgery. While natural orifice translumenal endoscopic surgery remains experimental, the single-incision approach could be the future of gallbladder surgery. Methods: Prospectively collected data from 875 patients subjected to conventional single-incision laparoscopic cholecystectomy (SILC) or 4-port [laparoscopic cholecystectomy (LC)] were retrospectively analyzed and discussed with the current literature. Results: Between 2008 and 2011, 201 (23%) SILCs and 674 (77%) LCs were performed. Mean age was 51.7 ± 17.5 years (SILC: 45.1 vs. LC: 53.7 y). Patients were predominantly female (SILC: 75.1% vs. LC: 56.5%). Preoperative body mass index was 27.4 ± 9.1 (SILC: 26.4 vs. LC: 27.8; P < 0.05) and American Society of Anesthesiologists’ score counted 1.67 ± 0.57 in SILC and 1.86 ± 0.7 in LC patients. Acute inflammation of the gallbladder (AIG) was not considered as a contraindication for SILC (AIG in SILC: 17.4% vs. LC: 35.5%). The mean operative time was significantly lower in the SILC group (SILC: 71 ± 31 vs. LC: 79 ± 27 min) and duration of postoperative hospital stay was shorter (SILC: 3.2 ± 1.7 vs. LC: 4.5 ± 2.6 d). No significant difference was observed between SILC and LC in any of the registered complications, including postoperative bleeding, trocar hernias, wound infection, abdominal abscess formation, bile duct injury, or cystic duct leakage. Conclusions: In the near future SILC could overrule conventional LC as the leading technique for gallbladder surgery. Our data reconfirm an excellent risk profile for SILC that is equal to that of LC. Large multicenter randomized controlled trials will be required to finally legitimize SILC as the succeeding principal method. Key Words: minimally invasive surgery, single-incision laparoscopic surgery, cholecystectomy

(Surg Laparosc Endosc Percutan Tech 2014;24:e207–e210)

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hen Muhe and coworkers performed the first laparoscopic cholecystectomy (LC) in 1985, they initiated the breakthrough of laparoscopic surgery in the operative treatment of hepatobiliary pathologies.1 To date, LC represents the gold standard for gallbladder removal.2–4 The crucial advantage of LC over open surgery is the

Received for publication March 18, 2013; accepted April 11, 2013. From the Department of Visceral, Transplant, and Thoracic Surgery, Innsbruck Medical University, Innsbruck, Austria. The authors declare no conflicts of interest. Reprints: Thomas Resch, MD, Department of Visceral, Transplant, and Thoracic Surgery, Innsbruck Medical University, Anichstrasse 35, Innsbruck A-6020, Austria (e-mail: [email protected]). Copyright r 2013 by Lippincott Williams & Wilkins

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minimization of an extended laparatomy to solely 4 trocar incisions. However, options for an even further minimization of surgical trauma are far from being exceeded with LC. Transgastric, transcolonic, or transvaginal approaches in terms of natural orifice translumenal endoscopic surgery have been invented to completely eliminate visible scarring and first clinical trials have been reported since 2007. However, these techniques currently remain at an experimental stage and are not feasible for a broad implementation.5–7 In contrast, the idea of an approach to enter the abdominal cavity by solely 1 single incision dates back already to the 1970s, when first inceptions in gynecology were carried out.8 In 1997, Navarra et al9 combined the 2 techniques, conventional LC and a single-incision laparoscopic approach (SILS), and developed what is known today as the “single-incision laparoscopic cholecystectomy” (SILC). However, the enthusiasm for SILC, as well as for SILS in general remained poor until 2005, when the report of the first SILS-adrenalectomy10 attracted attention and again highlighted the potentials of SILS. Along with a gradually developing variety of equipment suitable for SILS, such as articulating instruments and particularly multiport systems (eg, TriPort, Advanced Surgical Concepts; AirSeal; SurgiQuest Inc.; SILS port; Covidien, OCTO-Port; AFS Medical), the SILS-technique rapidly spread all over the world.11 The quest for less traumatic and minimally invasive procedures along with the increasing availability of a technical armamentarium currently leads to an implementation of SILS into various fields of surgery, such as colonic surgery,12–14 bariatric surgery,15,16 appendectomy,17,18 pancreatic surgery,19,20 or even emergency splenectomy.21 Importantly, at current, gallbladder surgery can be regarded as the most prominent field of application of the single-incision technique. However, despite its advantages, SILC has not yet overruled LC as the leading method for gallbladder removal. This is mainly because of a lack of validated data from large multicenter randomized controlled trials (RCT) which could attest SILC a safety profile that is equal to that of LC.11,22,23 Recently, Garg et al24 recapitulated the results from 9 small RCTs in a review article. The authors concluded that patients who underwent SILC profited from better cosmesis, whereas no differences could be observed in regard of postoperative complications. Interestingly, patients did not confer any benefit concerning postoperative pain or duration of hospital stay as compared with conventional LC.24 Noteworthy, in second recent analysis of 11 small randomized trials, Sajid et al25 did not

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find any advantage of SILC over LC, although the authors highlighted the strong heterogeneity among the trials. Hence, further evidence is crucially required to legitimize the steadily growing numbers of cholecystectomies performed in SILS technique.11,22 At Innsbruck Medical University we have been performing both, the conventional 4-port, and single-incision cholecystectomy from 2008. This study was designed to evaluate the feasibility and identify possible limitations of SILC when compared with the conventional multiport variant.

METHODS Patients Prospectively collected data from a 4-year period were retrospectively analyzed, including all patients who underwent LC or SILC at the surgical department of Innsbruck Medical University Hospital between January 2008 and December 2011. Informed consent was obtained for the procedure from all patients. The difference between the single-incision and the standard 4-incision approaches was explained. Clinical course and patient characteristics were compared between patients following LC and SILC.

Surgical Technique of SILC The patient is placed in a supine split-leg position allowing the surgeon to stand between split legs. The assistant is positioned at the left side of the patient. Under general anesthesia, a 20-mm single-curved intraumbilical incision is made and the abdomen is entered through an open technique. A detachable multichannel port is now installed. In this study, either a SILS port (Covidien), GelPOINT advanced access platform (Applied Medical), or the OCTO-Port (AFS Medical) were used. The patient’s position is now changed to a steep reverse Trendelenburg position. Pneumoperitoneum (12 mm Hg) is induced by insufflation of carbon dioxide, maintaining a continuous intra-abdominal pressure of 12 mm Hg. Using a 5-mm 30degree optic (Stryker), an initial exploration of all 4 quadrants of the abdominal cavity is performed to ensure absence of possible pathologies for example, adhesions. The gallbladder fundus is grasped and lifted until the cystohepatic triangle (triangle of Calot) is exposed. The peritoneal casing is removed with a coagulating hook (Coagulating electrode; Karl Storz) until the cystic duct and artery can be identified. Two proximal and 1 distal titanium clip are applied to each structure using a 5-mm clip applier (Ligamax; Ethicon). The cystic duct and artery are separately dissociated with a forceps (Clickline Scissors; Karl Storz), leaving the 2 proximal clips in situ. The gallbladder is now freed from the liver bed by use of the coagulating hook. In case of cholecystitis or perforation during preparation the gallbladder is removed by use of an extraction bag (Endo-Catch; Covidien). Otherwise the gallbladder is grabbed with a straight grasper (Karl Storz) and removed along with the multichannel port. The abdominal wall fascia is adapted by absorbable single button sutures (Vicryl 0; Ethicon). Skin closure is performed using intracutaneous running sutures.

Statistical Analysis Data analysis was performed using Prism 5.0 Software (GraphPad Software, La Jolla, CA). All data are expressed as mean (median) ± SD. Clinical parameters were analyzed

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using the Mann-Whitney U test. Differences between values were considered statistically significant at Pr0.05.

RESULTS Patients A total of 875 patients underwent laparoscopic gallbladder resection at our single institution between 2008 and 2011. Of these, 201 patients (23%) were subjected to SILC and 674 (77%) to conventional 4-port LC procedure (ratio SILC:LC = 1:3.4). Follow-up duration ranged between 1.4 and 48.9 months (LC: 25.6 ± 14.4 vs. SILC: 21.1 ± 10.7 mo). Mean age was 51.7 ± 17.5 years (SILC: 45.1 vs. LC: 53.7 y; P < 0.001). Females composed the majority of patients in both the groups, as expected by the nature of the disease (SILC: 75.1% vs. LC: 56.5%; P < 0.001). Mean preoperative body mass index was 27.4 ± 9.1 (SILC: 26.4 vs. LC: 27.8; P < 0.05). The mean preoperative American Society of Anesthesiologists score was 1.67 ± 0.57 in SILC and 1.86 ± 0.7 in LC patients (P < 0.05). Acute inflammation of the gallbladder (AIG) was not considered as a contraindication for SILC (AIG in SILC: 17.4% vs. LC: 35.5%; P < 0.001). In both the groups, cholecystolithiasis (SILC: 99.5% vs. 95.5%; P < 0.001) and histopathologic signs of chronic inflammation of the gallbladder (SILC: 93% vs. 76.5%; P < 0.001) were present in most subjects. The majority of surgical interventions was performed in an elective setting (SILC: 82% vs. LC: 57.2%; P < 0.001).

Operative Course The mean operative time was significantly lower in the SILC group when compared with the LC group (SILC: 71 ± 31 vs. LC: 79 ± 27 min, P < 0.001) (Fig. 1). Furthermore, the duration of postoperative hospital stay was significantly lower after SILC (SILC: 3.2 ± 1.7 vs. LC: 4.5 ± 2.6 d; P < 0.001) (Fig. 2). No intraoperative conversion to open surgery was required in the SILC group. This was the case in 4.6% with LC. However, in 3.5% at least 1 additional trocar had to be installed in the SILC group.

Complications No statistically significant difference was observed when comparing the surgical complications after SILC or LC. No intraoperative deaths occurred. Postoperative intra-abdominal bleeding necessitating revision occurred in 0.14% of LC and none in the SILC group (NS). The number of postoperative trocar hernias (SILC: 0.49% vs. LC: 1.33%; NS) and wound infections (SILC: 1.49% vs. LC: 2.07%; NS), was less after SILC by trend. Revision due to abscess formation in the gallbladder fossa was required in 0.14% of LC (SILC: 0%; NS). Cystic duct leakage was registered in 0.2% after SILC and 0.99% after LC (NS). Bile duct injury did not occur following SILC. This was the case in 0.14% of LC (NS) (Fig. 3).

DISCUSSION In analogy to the success of the conventional 4-port LC at the beginning of the 1990s, the novel SILC method currently experiences a rapidly gaining level of acceptance and popularity. In the future this exciting new modality in the field of minimal access surgery might become the leading technique. However, SILC is currently still far from becoming the gold standard.11,22 This might be because of r

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FIGURE 3. Complication rates: no statistically significant difference was observed when comparing the surgical complications after single-incision laparoscopic cholecystectomy (SILC) or laparoscopic cholecystectomy (LC).

FIGURE 1. Operative times were significantly lower in the singleincision laparoscopic cholecystectomy (SILC) group compared with laparoscopic cholecystectomy (LC) (SILC: 71 ± 31 vs. LC: 79 ± 27 min; ***P < 0.001).

several critical facts: Firstly, the safety of SILC has repeatedly been doubted.11 Fransen and colleagues recently reviewed 38 studies reporting outcomes after SILC and concluded that the number of complications seems favorable, although it seems too early to conclude that SILC is a safe procedure. The authors mainly criticized the preselected patients in the majority of articles, with cholecystitis being excluded in over 90%.26 In our present study, patients with cholecystitis were not excluded from the protocol. We observed no significant difference between SILC and LC in any of the registered complications, including postoperative bleeding, trocar hernias, wound infection, abdominal abscess formation, bile duct injury, or cystic duct leakage. Secondly, because of the slightly larger umbilical incision which is inevitable with SILC (approximately 2 cm), SILC has repeatedly been aspersed of being

FIGURE 2. A significant reduction in the length of postoperative hospital stay was observed with single-incision laparoscopic cholecystectomy (SILC) compared with laparoscopic cholecystectomy (LC) (SILC: 3.2 ± 1.7 vs. LC: 4.5 ± 2.6 d; ***P < 0.001). r

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associated with an increased risk for postoperative umbilical hernias. However, so far this argumentation seems to be unjustified. Except for 1 report,27 no elevated rates of hernias have been reported in short-term or long-term follow-ups.11,24,26,28–31 In this present study, which enrolls patients followed up from 2008 onwards, we report of registered trocar hernias after SILC ranging even below those observed after LC, by trend (SILC: 0.49% vs. LC: 1.33%; NS). Thirdly, SILC has been criticized as a seemingly unfeasible method due to a loss of triangulation. However, a recent series could demonstrate that an experienced surgeon can overcome the SILC-learning curve in only 8 cases.32 After adaption of the method among experienced surgeons in a surgical institution, an implementation of SILC as a routine and also teaching technique is feasible. In recent years this has been the case at our institution and consequently the majority of surgeries described in this present study were performed by resident surgeons. Fourthly, financial aspects have repeatedly been debated because of an accusation of prolonged operative times. We demonstrate that operative times could be significantly reduced with SILC compared with conventional LC (SILC: 71 ± 31 vs. LC: 79 ± 27 min, P < 0.001) (Fig. 1). Furthermore, a significant reduction in the length of postoperative hospital stay was observed (SILC: 3.2 ± 1.7 vs. LC: 4.5 ± 2.6 d; P < 0.001) (Fig. 2). Noteworthy, in this context it has to be mentioned that the compared groups were not matched for entirely identical distribution of risk factors, which is a clear limitation to this study. However, the large number of included patients [total: 875; SILC: 201 (23%); LC: 674 (77%)] allows a valid analysis of SILC advantages and disadvantages. The observed safety and feasibility combined with the obvious advantages related to the method have led to a continuously rising number of SILC procedures at our institution. This results in a steadily lowering number of surgeries performed as traditional 4-port LC. However, in our opinion several key aspects should be considered when performing SILC: even though the transumbilical approach can be implemented as the standard procedure, the decision for the introduction of additional trocars should be made early, for example, in case of pronounced intra-abdominal adhesions. Furthermore, in case of suspected malignancy conversion to open surgery should be performed immediately. In regard of the slightly larger umbilical incision (2 cm), an exact closure of the abdominal wall fascia is of pivotal importance. This should be performed using absorbable single-knot sutures (eg, Vicryl 0; Ethicon). www.surgical-laparoscopy.com |

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CONCLUSIONS In the near future, SILC could overrule conventional LC as the leading technique for gallbladder surgery. Our data reconfirm an excellent risk profile for SILC that is equal to that of LC. Patients clearly benefit from the minimization of trauma. Large multicenter RCTs will be required to finally legitimize SILC as the succeeding principal method. We are convinced that SILC can be regarded as the “natural evolution” in modern times of minimally invasive surgery. REFERENCES 1. Reynolds W, Jr. The first laparoscopic cholecystectomy. JSLS. 2001;5:89–94. 2. Mouret P. How I developed laparoscopic cholecystectomy. Ann Acad Med Singapore. 1996;25:744–747. 3. Yoshida M, Furukawa T, Morikawa Y, et al. The developments and achievements of endoscopic surgery, robotic surgery and function-preserving surgery. Jpn J Clin Oncol. 2010;40:863–869. 4. Rao PP, Rao PP, Bhagwat S. Single-incision laparoscopic surgery—current status and controversies. J Minim Access Surg. 2011;7:6–16. 5. Noguera JF, Cuadrado A. NOTES, MANOS, SILS and other new laparoendoscopic techniques. World J Gastrointest Endosc. 2012;4:212–217. 6. Coomber RS, Sodergren MH, Clark J, et al. Natural orifice translumenal endoscopic surgery applications in clinical practice. World J Gastrointest Endosc. 2012;4:65–74. 7. Clark MP, Qayed ES, Kooby DA, et al. Natural orifice translumenal endoscopic surgery in humans: a review. Minim Invasive Surg. 2012;2012:189296–189304. 8. Junker H. Laparoscopic tubal ligation by the single puncture technique (author’s transl). Geburtshilfe Frauenheilkd. 1974; 34:952–955. 9. Navarra G, Pozza E, Occhionorelli S, et al. One-wound laparoscopic cholecystectomy. Br J Surg. 1997;84:695–695. 10. Hirano D, Minei S, Yamaguchi K, et al. Retroperitoneoscopic adrenalectomy for adrenal tumors via a single large port. J Endourol. 2005;19:788–792. 11. Greaves N, Nicholson J. Single incision laparoscopic surgery in general surgery: a review. Ann R Coll Surg Engl. 2011;93:437–440. 12. Makino T, Milsom JW, Lee SW. Feasibility and safety of single-incision laparoscopic colectomy: a systematic review. Ann Surg. 2012;255:667–676. 13. Vestweber B, Alfes A, Paul C, et al. Single-incision laparoscopic surgery: a promising approach to sigmoidectomy for diverticular disease. Surg Endosc. 2010;24:3225–3228. 14. Singh J, Podolsky ER, Castellanos AE, et al. Optimizing single port surgery: a case report and review of technique in colon resection. Int J Med Robot. 2011;7:127–130. 15. Huang CK. Single-incision laparoscopic bariatric surgery. J Minim Access Surg. 2011;7:99–103. 16. Saber AA, El Ghazaly TH, Dewoolkar AV. Single-incision laparoscopic bariatric surgery: a comprehensive review. Surg Obes Relat Dis. 2010;6:575–582.

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17. Rehman H, Rao AM, Ahmed I. Single incision versus conventional multi-incision appendicectomy for suspected appendicitis. Cochrane Database Syst Rev. 2011;7:CD009022. 18. Kang KC, Lee SY, Kang DB, et al. Application of single incision laparoscopic surgery for appendectomies in patients with complicated appendicitis. J Korean Soc Coloproctol. 2010;26:388–394. 19. Kuroki T, Adachi T, Okamoto T, et al. Single-incision laparoscopic distal pancreatectomy. Hepatogastroenterology. 2011;58:1022–1024. 20. Barbaros U, Sumer A, Demirel T, et al. Single incision laparoscopic pancreas resection for pancreatic metastasis of renal cell carcinoma. JSLS. 2010;14:566–570. 21. Fan Y, Wu SD, Siwo EA. Emergency transumbilical singleincision laparoscopic splenectomy for the treatment of traumatic rupture of the spleen: report of the first case and literature review. Surg Innov. 2011;18:185–188. 22. Koo EJ, Youn SH, Baek YH, et al. Review of 100 cases of single port laparoscopic cholecystectomy. J Korean Surg Soc. 2012;82:179–184. 23. Joseph M, Phillips MR, Farrell TM, et al. Single incision laparoscopic cholecystectomy is associated with a higher bile duct injury rate: a review and a word of caution. Ann Surg. 2012;256:1–6. 24. Garg P, Thakur JD, Garg M, et al. Single-incision laparoscopic cholecystectomy vs. conventional laparoscopic cholecystectomy: a meta-analysis of randomized controlled trials. J Gastrointest Surg. 2012;16:1618–1628. 25. Sajid MS, Ladwa N, Kalra L, et al. Single-incision laparoscopic cholecystectomy versus conventional laparoscopic cholecystectomy: meta-analysis and systematic review of randomized controlled trials. World J Surg. 2012;36:2644–2653. 26. Fransen S, Stassen L, Bouvy N. Single incision laparoscopic cholecystectomy: a review on the complications. J Minim Access Surg. 2012;8:1–5. 27. Alptekin H, Yilmaz H, Acar F, et al. Incisional hernia rate may increase after single-port cholecystectomy. J Laparoendosc Adv Surg Tech A. 2012;22:731–737. 28. Madureira FA, Manso JE, Madureira FD, et al. Randomized clinical study for assessment of incision characteristics and pain associated with LESS versus laparoscopic cholecystectomy. Surg Endosc. 2013;27:1009–1015. 29. Wang Z, Huang X, Zheng Q. Single-incision versus conventional laparoscopic cholecystectomy: a meta-analysis. ANZ J Surg. 2012;82:885–889. 30. Wu XS, Shi LB, Gu J, et al. Single-incision laparoscopic cholecystectomy versus multi-incision laparoscopic cholecystectomy: a meta-analysis of randomized clinical trials. J Laparoendosc Adv Surg Tech A. 2013;23:183–191. 31. Kim BS, Kim KC, Choi YB. A comparison between singleincision and conventional laparoscopic cholecystectomy. J Laparoendosc Adv Surg Tech A. 2012;22:443–447. 32. Han HJ, Choi SB, Park MS, et al. Learning curve of single port laparoscopic cholecystectomy determined using the non-linear ordinary least squares method based on a non-linear regression model: an analysis of 150 consecutive patients. J Hepatobiliary Pancreat Sci. 2011;18:510–515.

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Single-incision laparoscopic cholecystectomy: will it succeed as the future leading technique for gallbladder removal?

The quest for less traumatic abdominal approaches is changing paradigms in times of minimally invasive surgery. While natural orifice translumenal end...
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