Abstract Common bile duct exploration (CBDE) is an operation that can be performed either laparoscopically or open in order to treat choledocholithiasis by removing stones from the common bile duct. CBDE can be performing via either a transcystic approach or a transcholedochal one, in which an incision (or choledochotomy) is made directly into the common bile duct in order to access the stones within it. Traditionally this cholecdochotomy have been closed around an external drain, or “T-tube”, at the end of CBDE operations, in order to drain the biliary system and allow access for future interventions should the need arise. However, recent data suggesting that primary closure of the choledochotomy may in fact be a superior technique have challenged the surgical dogma of routine T-tube placement after CBDE. In this chapter we summarize and evaluate the available evidence comparing T-tube drainage with primary choledochotomy closure after CBDE. Six randomized trials have compared these strategies after open CBDE, and four such trials have been performed for laparoscopic CBDE. The existing literature mostly examines perioperative and short-term postoperative outcomes, such as operative time, 30-day postoperative morbidity and mortality, hospital length of stay, and need for reinterventions during the immediate postoperative period. Long-term implications of using or foregoing T-tube drainage have not been as well studied. Based on these studies, there is a high level of evidence that primary choledochotomy closure after CBDE (both open and laparoscopic) results in shorter operative times and shorter hospital length of stay when compared with t-tube drainage. There is moderate evidence that primary closure and t-tube drainage after CBDE result in equivalent rates of serious complications in the perioperative period. Due to insuffi cient data, there is a very low level of evidence that the two techniques result in equivalent rates of long-term recurrent choledocholithiasis and biliary stricture. Based on the sum of this evidence, we make a moderate strength recom- E. N. Teitelbaum • A. D. Yang • D. M. Mahvi (*) Department of Surgery , Northwestern University , 251 E. Huron St., Galter Room 3-710 , Chicago , IL 60611 , USA e-mail: [email protected] 210 mendation that primary choledochotomy closure should be the preferred technique in uncomplicated cases of both open and laparoscopic CBDE. Keywords Common bile duct exploration • Choledocholithiasis • T-tube • Choledochotomy closure • Bile duct surgery • Hepatobiliary Introduction Choledocholithiasis, or stones within the common bile duct , occurs in between 3.4 and 17 % of patients with symptomatic gallstone disease [ 1 , 2 ]. Currently, two standard- of-care approaches exist for treating patients with choledocholithiasis . The fi rst involves performing an endoscopic retrograde cholangiopancreatography ( ERCP ) in order to remove the stone or stones from the common bile duct. However, with this approach, a cholecystectomy must also be subsequently performed in order to eliminate the source of the stones and thus prevent disease recurrence. Alternatively, a surgical common bile duct exploration (CBDE) can be performed in either an open or laparoscopic fashion at the time of cholecystectomy, in order treat the patient’s current problem and prevent future episodes, all with a single procedure. CBDE was fi rst performed in 1890 by Courvoisier and in the early 1990s with the widespread adoption of laparoscopic cholecystectomy , CBDE was fi rst performed in a laparoscopic, minimally invasive fashion. CBDE at the time of cholecystectomy, especially when performed laparoscopically, has been shown to result in a shorter hospital length of stay, less hospital costs, and possibly fewer complications, when compared with the two-stage approach of ERCP and cholecystectomy [ 3 , 4 ]. Two primary methods exist for performing CBDE: transcystic and transcholedochal. In the transcystic approach, a fl exible choledochoscope or fl uoroscopicallydirected instruments are inserted through a ductotomy in the cystic duct (similar to that through which a standard intraoperative cholangiogram is performed). In the transcholedochal method, a longitudinal ductotomy is made into the common duct itself, through which a choledochoscope and/or other instruments are passed in order to capture the stones within. At the conclusion of a transcholedochal CBDE, the choledochotomy can be dealt with in two ways: (1) it can be closed primarily or (2) a “ T-tube ” can be placed into the choledochotomy, the ductomy then closed around the tube, and opposite end of the tube externalized to bag drainage (Fig. 18.1 ). Placing a T-tube drain after CBDE offers several theoretical advantages and is still considered to be the standard of care by many surgeons. A T-tube allows for external drainage of the biliary system in the case of residual biliary obstruction from retained stones, ampullary edema, or stenosis. Additionally, the biliary system can be instrumented through the T-tube under fl uoroscopic guidance, in order to treat the postoperative conditions mentioned previously without the need for additional procedures or operations. Finally, a T-tube is thought to prevent stricture of E.N. Teitelbaum et al. 211 the common bile duct , although this is a theoretical advantage without comparative data to either support or refute it. Conversely, T-tube placement at the conclusion of an otherwise successful CBDE carries its own set of risks. The tube offers an avenue for infection of the biliary system and it can become dislodged prematurely in the postoperative period, resulting in a biliary leak. A leak can also occur when the T-tube is eventually removed intentionally, if an adequate tract to the skin has not formed. Since T-tube drainage after CBDE confers both potential advantages and disadvantages, this operative strategy has been compared with primary choledochotomy closure in several well-designed studies. This chapter will deal exclusively with the clinical decision of whether to place a T-tube or perform a primary choledocotomy closure after transcholedochal CBDE. We will discuss the results of trials examining these alternative operative strategies, summarize the existing evidence, make recommendations regarding the evidence supporting the best answer to this clinical question, and discuss the limitations to those recommendations. Search Strategy A search of English language publications was performed to assess existing evidence comparing the use of T-tube drainage and primary closure after CBDE using the PICO outline shown in Table 18.1 . Databases searched were PubMed, Ovid MEDLINE, and Cochrane Evidence Based Medicine . Search terms used were To drainage collection Duodenum T-tube in comman bile duct Cystic duct tied off Hepatic duct Fig. 18.1 A cartoon depicting the anatomy of placement of a T-tube after open transcholedochal CBDE and concurrent cholecystectomy for treatment of choledocholithiais. The opposite end of the tube exits through a stabincision in the abdominal wall and is placed either to bag drainage or occluded (Figure used with permission from O’Toole MT [ 21 ]) 18 Primary Closure or T-Tube Drainage After Open or Laparoscopic Common Bile… 212 “ common bile duct exploration ”, “ laparoscopic common bile duct exploration ”, “ open common bile duct exploration”, “ choledocholithiasis ”, “transcholedochal” AND “T-tube”, “biliary drainage”, “tube drainage”, “primary closure”, “ choledochotomy closure ”. Trials comparing primary closure and T-tube drainage after transcholedochal CBDE (both open and laparoscopic) were included in the subsequent analysis. Results Six randomized trials including a total of 359 patients have compared the strategies of primary closure versus T-tube drainage after open CBDE [ 5 – 10 ]. Four such trials with 399 total patients have been performed for laparoscopic CBDE [ 11 – 14 ]. Additionally two Cochrane Group meta-analyses have been performed which aggregated and analyzed these studies (one for open CBDE [ 15 ] and one for laparoscopic [ 16 ]). The existing literature mostly examines perioperative and short-term postoperative outcomes , such as operative time, 30-day postoperative morbidity and mortality , hospital length of stay, and need for re-interventions during the immediate postoperative period. Long-term implications of using or foregoing T-tube drainage have not been as well studied. The following sections discuss the available evidence with respect to specifi c outcomes after both open and laparoscopic CBDE. Tables 18.2 and 18.3 summarize these quantitative comparison data comparing primary closure to T-tube drainage for open and laparoscopic CBDE respectively. Operative Time Placement of a T-tube after CBDE, whether open or laparoscopic , requires several discrete steps: the limbs of the t-tube are fashioned into the proper lengths and confi guration, the tube is inserted into the common ductotomy, the ductotomy is partially sutured closed so that the T-tube is secured in position but not so tightly that it cannot eventually be removed, and the external portion of the tube must be brought Table 18.1 PICO terms used in defi ning the clinical question and search strategy P (Patients) I (Intervention) C (Comparator) O (Outcomes) Patients with choledocholithiasis treated with open or laparoscopic transcholedochal common bile duct exploration (CBDE) Primary closure of the choledochotomy at the conclusion of CBDE T-tube placement through the choledochotomy for postoperative biliary drainage at the conclusion of CBDE Operative time, mortality, serious morbidity, hospital length of stay, recurrent choledocholithiasis, biliary stricture E.N. Teitelbaum et al. 213 out through to the skin. This is opposed to the strategy of primary closure, during which the common ductotomy is simply sutured closed in order to conclude the procedure. Accordingly, it seems intuitive that primary closure should result in shorter operative times, and this appears to have been borne out in the randomized studies that have compared the two approaches for both laparoscopic and open CBDE. Of the randomized trails performed for open CBDE, only one compared operative times, and found primary closure to be faster by 28 min [ 5 ]. The evidence for laparoscopic CBDE is more robust, with all four randomized trials comparing operative times. All of these studies demonstrated shorter operative times in their primary closure patients, with similar mean differences between the groups ranging from 17 to 26 min [ 11 – 14 ]. Perioperative Mortality and Morbidity When performed in experienced hands, both open and laparoscopic CBDE carry a very low risk of perioperative mortality . As such, it is not surprising that even when the results of all randomized trials are aggregated, there are no differences in mortality between primary closure and T-tube drainage. In studies of open CBDE the aggregate perioperative mortality with t-tube drainage was 1.2 %, as opposed to 0.6 % with primary closure [ 15 ], and this difference was not statistically signifi cant. In the four randomized trials comparing these techniques for laparoscopic CBDE, there were no perioperative deaths among the 399 patients, which speaks to both the safety and physiologic benefi ts of a laparoscopic approach. Serious morbidity has also not been conclusively shown to differ between primary ductotomy closure and T-tube drainage, although there may be an advantage Table 18.2 Comparison of compiled data from randomized trials comparing primary closure versus T-tube drainage for open CBDE [ 15 ] Outcomes Primary closure T-tube drainage Operative time (mins) 88* 117 Mortality (%) 0.6 1.2 Serious morbidity (%) 6.6 14.5 Hospital stay (days) 9.1* 13.8 *p < 0.05 in favor of primary closure Table 18.3 Comparison of compiled data from randomized trials comparing primary closure versus T-tube drainage for laparoscopic CBDE [ 16 ] Outcomes Primary closure T-tube drainage Operative time (mins) 106* 127 Mortality (%) 0 0 Serious morbidity (%) 6.1 9.7 Hospital stay (days) 3.9* 7.2 *p < 0.05 in favor of primary closure 18 Primary Closure or T-Tube Drainage After Open or Laparoscopic Common Bile… 214 to primary closure in this regard. A meta-analysis of trials comparing the approaches after open CBDE, found a serious morbidity rate of 14.5 % after T-tube drainage, as opposed to 6.6 % after primary closure, although this difference narrowly missed obtaining statistical signifi cance. Similarly, when the trials comparing the approaches during laparoscopic CBDE were analyzed, the overall serious complication rate was 11.3 % in the T-tube group versus 6.1 % in the primary closure patients; however, this difference was also not statistically signifi cant. A closer examination of the results of these trials reveals that a number of these serious complications were directly related to use of the T-tube , and thus these trials may simply not be adequately powered to detect the added risk that T-tube placement confers (i.e., a Type II statistical error is present). For example, patients in several trials required reoperation for replacement of prematurely dislodged T-tubes, in some cases leading to bile peritonitis. Also, bile leak age after T-tube removal occurred in approximately 1–2 % of patients, which usually required either replacement of another tube through the existing tract, percutaneous drainage of a bile collection, or reoperation for drainage and tube replacement. This is in contrast to the primary closure group, in which bile leakage from the choledochotomy closure occurred in less than 1 % of patients, and could almost uniformly be treated with ERCP sphincterotomy and/or stenting without the need for reoperation [ 15 ]. Therefore, even when a “serious morbidity ” occurs after CBDE with primary closure, it appears to result in less severe consequences for the patient when contrasted with complications directly related to the use of a T-tube. Hospital Length of Stay The use of a T-tube adds another clinical variable, as the drain outputs must be tracked, the decision to place the tube to drainage versus clamping is weighed, and routine and/or clinically-prompted T-tube cholangiograms are often obtained in order to evaluate for biliary obstruction and/or leakage. Additionally, patients must be educated regarding the self-care and management of the tube at home prior to leaving the hospital. All of these factors can potentially lead to longer hospital length of stay in the perioperative period, and this has been refl ected in the literature examining both open and laparoscopic CBDE. In trials comparing approaches for open CBDE, primary closure resulted in a marked advantage over T-tube drainage, with a mean difference in hospital length of stay of 4.7 days [ 15 ]. This superiority of primary closure was also present to a lesser extent in the trials involving laparoscopic CBDE, with a mean difference of 3.3 days. The smaller difference in length of stay after laparoscopic CBDE is likely due to the overall decreased length of stay after laparoscopic, when compared with open, surgery then to a less signifi cant advantage of primary closure over t-tube drainage. Additionally, one study compared time to return to work, and found patients undergoing primary closure did so 8 days earlier than those with T-tubes [ 13 ]. E.N. Teitelbaum et al. 215 Long-Term Outcomes Most trials have focused on perioperative outcomes when comparing the strategies of primary closure and T-tube drainage after CBDE, but some longer-term outcomes data does exist. One of the theoretical reasons behind the use of a T-tube is to facilitate biliary access in the case of retained stones and/or prevent biliary stricture . However, in the limited outcomes data available, neither of these potential complications appear to be either frequent or lessened in severity by the use of T-tube drainage at the time of initial CBDE. In experienced hands, the rate of a retained common duct stones is less than 5 % for both open and laparoscopic CBDE. Additionally, missed stones are usually small, and thus are almost universally retrievable via ERCP , obviating the need for T-tube access to the biliary system in the rare instance that they do occur. In the three open and one laparoscopic trials that evaluated longer-term outcomes at 6-months to 2.5 years, no patients in either arm (primary closure or t-tube drainage) had either recurrence of choledocholithiasis or new-onset of biliary stricture [ 5 , 6 , 10 , 11 ]. There are no studies examining outcomes beyond 2.5 years. Recommendations Based on the Data 1. Primary choledochotomy closure after CBDE (both open and laparoscopic ) results in shorter operative times and shorter hospital length of stay when compared with t-tube drainage – HIGH level of evidence 2. Primary closure and t-tube drainage after CBDE result in equivalent rates of serious complications in the perioperative period – MODERATE level of evidence 3. Primary closure and t-tube drainage after CBDE result in equivalent rates of long-term recurrent choledocholithiasis and biliary stricture – VERY LOW level of evidence 4. Primary choledochotomy closure should be the preferred technique in uncomplicated cases of both open and laparoscopic CBDE – MODERATE strength recommendation Potential Exceptions to Recommendations As with any surgical disease and operation, each patient undergoing CBDE for choledocholithiasis must be evaluated individually, and various factors must be taken into account when determining the most benefi cial approach to their condition. That is to say, despite our moderate strength recommendation of the use of primary closure, there are many instances in which T-tube drainage might be the superior option for a given patient. For example, if a completion cholangiogram at the conclusion of 18 Primary Closure or T-Tube Drainage After Open or Laparoscopic Common Bile… 216 a CBDE procedure demonstrates poor fl ow of contrast into the duodenum despite an absence of stones in the common bile duct , edema or stricture at the Ampulla of Vater may be present. In this case, placing a T-tube would be the best option, as both drainage and instrumentation of the biliary system will likely be necessary in the immediate postoperative period. Alternatively, if a patient undergoing CBDE has a prior Roux-en-Y gastric bypass that precludes future ERCP , the safest option may be to place a T-tube, so that the biliary system can be accessed easily in the case of a retained stone or bile leak age. Finally, the lack of data regarding the incidence of biliary stricture beyond 2.5 years should also be taken into account when making the decision for or against T-tube placement at the time of CBDE. Utilization of CBDE and Future Directions for Training While it is important to study technical considerations such as T-tube drainage versus primary closure, CBDE still remains an extremely underutilized method for treating common bile duct stones. This remains true despite the advantages of CBDE (particularly laparoscopic CBDE) compared to ERCP [ 3 , 4 ]. For example, a study examining data from the United States National Inpatient Sample found that of patients admitted to hospitals with a diagnosis of choledocholithiais, 93 % were treated with ERCP as opposed to 7 % with CBDE [ 17 ]. Several reasons likely exist for this disparity including: lack of CBDE instrument availability, lack of familiarity with the procedure on the part of surgeons and support staff, and relatively poor fi nancial reimbursement for surgeons. The lack of exposure to, and training in, CBDE during surgical residency is almost certainly a central barrier to more widespread adoption of CBDE for treatment of choledocholithiasis . A review of residents’ operative case logs showed that graduating chief residents had performed a mean of 1.7 open and 0.7 laparoscopic CBDE procedures during their entire residency, with a mode of 1 and 0 respectively [ 18 ]. This limited experience is not suffi cient for gaining competency with either primary choledochotomy closure or T-tube placement, let alone the remainder of the skills required to perform CBDE. In order to address this lack of exposure to CBDE during residency and hopefully increase the utilization of procedure at our institution, we have developed a laparoscopic CBDE simulator for training and evaluation purposes [ 19 ]. The simulator recreates the three visualization modalities involved in the operation (laparoscopic, endoscopic , and fl uoroscopic), and trainees are able to perform a complete simulated procedure via either a transcystic or transcholedochal approach. We have been able to demonstrate that a technical curriculum based around practice on the simulator is able to consistently train senior surgery residents to the level of a predetermined “mastery standard” over the course of a two-month rotation [ 20 ]. Hopefully, similar training initiates can be developed nationally, with the goal of increasing the utilization of CBDE and ultimately improving patient outcomes . If CBDE becomes more commonly used by surgeons for the treatment of choledochoE.N. Teitelbaum et al. 217 lithisis, the question of whether to perform a primary choledochotomy closure or leave a T-tube for biliary drainage will become even more clinically relevant and important. References 1. Houdart R, Perniceni T, Darne B, Salmeron M, Simon JF. Predicting common bile duct lithiasis: determination and prospective validation of a model predicting low risk. Am J Surg. 1995;170:38–43. 2. Collins C, Maguire D, Ireland A, Fitzgerald E, O’Sullivan GC. A prospective study of common bile duct calculi in patients undergoing laparoscopic cholecystectomy: natural history of choledocholithiasis revisited. Ann Surg. 2004;239:28–33. 3. Cuschieri A, Lezoche E, Morino M, et al. E.A.E.S. multicenter prospective randomized trial comparing two-stage vs single-stage management of patients with gallstone disease and ductal calculi. Surg Endosc. 1999;13:952–7. 4. Rogers SJ, Cello JP, Horn JK, et al. Prospective randomized trial of LC+LCBDE vs ERCP/ S+LC for common bile duct stone disease. Arch Surg. 2010;145:28–33. 5. Marwah S, Singh I, Godara R, Sen J, Marwah N, Karwasra RK. Evaluation of primary duct closure vs T-tube drainage following choledochotomy. Indian J Gastroenterol. 2004;23:227–8. 6. Ambreen M, Shaikh AR, Jamal A, Qureshi JN, Dalwani AG, Memon MM. Primary closure versus T-tube drainage after open choledochotomy. Asian J Surg/Asian Surg Assoc. 2009;32:21–5. 7. Lygidakis NJ. Choledochotomy for biliary lithiasis: T-tube drainage or primary closure. Effects on postoperative bacteremia and T-tube bile infection. Am J Surg. 1983;146:254–6. 8. Makinen AM, Matikainen M, Nordback I. T-tube drainage is needed after routine common bile duct closure: results of a randomized trial. Surg Res Commun. 1989;6:299–302. 9. Payne RA, Woods WG. Primary suture or T-tube drainage after choledochotomy. Ann R Coll Surg Engl. 1986;68:196–8. 10. Williams JA, Treacy PJ, Sidey P, Worthley CS, Townsend NC, Russell EA. Primary duct closure versus T-tube drainage following exploration of the common bile duct. Aust N Z J Surg. 1994;64:823–6. 11. Dong ZT, Wu GZ, Luo KL, Li JM. Primary closure after laparoscopic common bile duct exploration versus T-tube. J Surg Res. 2014;189:249–54. 12. Zhang WJ, Xu GF, Wu GZ, Li JM, Dong ZT, Mo XD. Laparoscopic exploration of common bile duct with primary closure versus T-tube drainage: a randomized clinical trial. J Surg Res. 2009;157:e1–5. 13. Leida Z, Ping B, Shuguang W, Yu H. A randomized comparison of primary closure and T-tube drainage of the common bile duct after laparoscopic choledochotomy. Surg Endosc. 2008;22:1595–600. 14. El-Geidie AA. Is the use of T-tube necessary after laparoscopic choledochotomy? J Gastrointest Surg. 2010;14:844–8. 15. Gurusamy KS, Koti R, Davidson BR. T-tube drainage versus primary closure after open common bile duct exploration. Cochrane Database Syst Rev. 2013;6, CD005640. 16. Gurusamy KS, Koti R, Davidson BR. T-tube drainage versus primary closure after laparoscopic common bile duct exploration. Cochrane Database Syst Rev. 2013;6, CD005641. 17. Poulose BK, Arbogast PG, Holzman MD. National analysis of in-hospital resource utilization in choledocholithiasis management using propensity scores. Surg Endosc. 2006;20:186–90. 18. Helling TS, Khandelwal A. The challenges of resident training in complex hepatic, pancreatic, and biliary procedures. J Gastrointest Surg. 2008;12:153–8. 18 Primary Closure or T-Tube Drainage After Open or Laparoscopic Common Bile… 218 19. Santos BF, Reif TJ, Soper NJ, Nagle AP, Rooney DM, Hungness ES. Development and evaluation of a laparoscopic common bile duct exploration simulator and procedural rating scale. Surg Endosc. 2012;26:2403–15. 20. Teitelbaum EN, Soper NJ, Santos BF, et al. A simulator-based resident curriculum for laparoscopic common bile duct exploration. Surgery. 2014;156:880–7, 90–3. 21. O’Toole MT, editor. Miller-Keane encyclopedia and dictionary of medicine, nursing and allied health. 7th ed. Philadelphia: Saunders; 2003. E.N. Teitelbaum et al. © Springer International Publishing Switzerland 2016 219 J.M. Millis, J.B. Matthews (eds.), Diffi cult Decisions in Hepatobiliary and Pancreatic Surgery, Diffi cult Decisions in Surgery: An Evidence-Based Approach, DOI 10.1007/978-3-319-27365-5_19 Chapter 19 Single-Incision or Multiport Laparoscopic Cholecystectomy Bill Ran Luo and Nathaniel J. Soper Abstract This chapter reviews the current body of literature comparing multi-port laparoscopic cholecystectomy versus single incision laparoscopic cholecystectomy; specifi cally differences between complications, conversion rates, pain, cosmesis, quality of life, cost, and rate of hernia formation. Keywords Laparoscopic cholecystectomy • Single-incision • Multi-port • Morbidity • Pain • Cosmesis • Cost Introduction Laparoscopic cholecystectomy is one of the most common operations performed in the western world today. The standard of care for gallbladder removal prior to the 1980s was an open cholecystectomy , but with the acceptance of laparoscopic cholecystectomy as a standard technique in the 1990s, the world of minimally invasive surgery for gallbladder pathology expanded [ 2 ]. After an initial learning curve, laparoscopic cholecystectomy was demonstrated to have an overall complication rate of less than 5 % with an established rate of common bile duct injury between 0.3 and 0.5 % [ 1 ]. Given the drive for surgeons to continue to innovate and create less invasive surgical techniques, single incision laparoscopic cholecystectomies have developed a large base of support. However, as standard multi-port laparoscopic cholecystectomy (MPLC) has such proven and safe results, single incision cholecystectomy naturally must be analyzed and dissected critically, to ensure that outcomes are cost effective, effi cient, and, most importantly, safe for patients. These single incision approaches have multiple eponyms; including single incision B. R. Luo • N. J. Soper (*) Department of Surgery , Northwestern Medicine , 251 E. Huron St. Galter 3-150 , Chicago , IL 60611 , USA e-mail: [email protected] 220 laparoscopic surgery (SILS), single port access (SPA), and laparo- endoscopic single site (LESS). In this chapter, we will abbreviate the single-incision laparoscopic cholecystectomy as SILC. Search Strategy A literature search of English language publications from 2000 to 2014 was used to identify published data on single incision and multi-port laparoscopic cholecystectomy comparative results in the adult population using the PICO outline. Databases searched were PubMed, Embase, Science Citation Index/Social sciences Citation Index and Cochrane Evidence Based Medicine . Terms used in the search were “single incision cholecystectomy ”, “SILS” “single access cholecystectomy”, “SPA”, “single port cholecystectomy”, “laparoendoscopic single site cholecystectomy”, “LESS”, “multi-port laparoscopic cholecystectomy”, “standard laparoscopic cholecystectomy”, “conventional cholecystectomy”, “conventional laparoscopic cholecystectomy” AND “ cost ” OR “ pain ” OR “ morbidity ” OR “ mortality ” OR “conversion” OR “conversion rate” OR “effectiveness” OR “operative time” OR “ cosmesis ” OR “hernia” OR “hernia rates” OR “complications” OR “admission” OR “re-admission” OR “ outcomes ” OR “randomized trials” OR “randomised trials” OR “prospective trials”. Articles were excluded if they exclusively addressed open cholecystectomy, natural orifi ce (NOTES) cholecystectomy, robotic cholecystectomy, or pediatric patients. Ten randomized controlled trials, 11 retrospective studies, and 6 systematic reviews were included in our analysis. The data were classifi ed using the GRADE system. Results of Single Incision Laparoscopic Cholecystectomy Compared with Standard Multi-port Laparoscopic Cholecystectomy Peri-operative Morbidity and Mortality Laparoscopic cholecystectomy has evolved to be an operation that is safe for patients for both acute cholecystitis and in the elective setting, with low morbidity (3.1 %) and mortality (0.3 %) [ 1 ]. There have been no reported mortalities following SILC in any published studies [ 3–7, 10 – 25 , 27 , 30 ]. With analysis of all adverse events, the data favored MPLC, with an odds ratio of 1.14 (0.69–1.91) [ 27 ]. One meta-analysis that stratifi ed expertise bias showed a difference in complications for SILC (5.35 %) versus conventional (3.79) in non-expert hands [ 31 ]. However, other B.R. Luo and N.J. Soper 221 studies showed either no difference or an improved overall complication rate for SILC [ 20 , 30 ]. There were no differences for major biliary complications, which for SILC ranged from 0.3 to 0.5 % [ 8 , 15 , 28, 29, 31 ]. Bleeding risks appear to be equivalent between the two techniques, about 1 % in these studies [ 16 , 20 , 26 ], with one study showing a minimal favorability toward MPLC [ 27 ]. Periumbilical port site infections for SILC trended higher in some studies, but failed to reach statistical signifi cance [ 20 , 26 ]. Based on the available randomized trials and meta – analyses – there is high level evidence that there is no difference in mortality , major complications , or biliary complications ( Grade 1A recommendation that either SILC or MPLC are safe approaches ), but there is low level evidence which suggests that there may be a small increase in adverse events and port site infections in SILC patients ( Grade 2C recommendation in favor of MPLC ). Conversion Rates There were no differences between conventional and SILC in conversion rates to a laparotomy, with rates as low as 0.2 % [ 26 , 31 ]. More likely is the conversion from SILC to MPLC, with variable rates of 0.2 % up to 8 %, but these conversions were proven to be safe in multiple studies [ 24 , 27 , 30 ]. There is high level evidence that conversion from SILC to MPLC is safe , as well as high level evidence that rates of conversion to a laparotomy for both procedures are negligible and comparable in the elective setting . ( Grade 1A recommendation that either SILC or MPLC are safe modalities ). Cost One of the largest prospective randomized trials comparing MPLC and SILC found signifi cant increases in charges for SILC, specifi cally increased total hospital charges of $2,100, surgical equipment $1,700, operating room costs $913, and anesthesia costs $241 [ 19 ]. There were no differences in pharmacy, laboratory, recovery room, observation or ICU costs. These increases in costs were consistently higher for SILC in several other studies, although the increased costs ranged from $400 to 964 with some variability in signifi cance [ 9 , 12 , 26 ]. Only one retrospective study analyzed cost , showing a slight increase in SILC patients, but only those that converted to MPLC. The rest of the large prospective randomized trials did not analyze the cost differences between the two. There is moderate level evidence that SILC incurs more hospital costs when compared with MPLC . ( Grade 1B recommendation in favor of MPLC .) 19 Single-Incision or Multiport Laparoscopic Cholecystectomy 222 Pain Leung et al. demonstrated signifi cantly higher level of pain in SILC group at postoperative day 1 and day 3. However, by post-operative week 1 the pain score became comparable [ 19 ]. Marks et al. demonstrated no difference in pain scores at 1 day, 1 week, and 2 weeks, but on day 3 and day 5 there was a statistically signifi cant increase in pain scores in the SILC group [ 20 ]. Lai et al. reported no difference between the two groups 6 h postoperatively, but 7 days later the SILC group had signifi cantly more pain [ 16 ]. Milas et al. showed high heterogeneity, with no statistical signifi cance when it came to pain scores, but had a trend toward higher scores in SILC patients [ 31 ]. Trasuli et al. showed no signifi cant difference in pain scores in the pooled data at any of the early time points out to 48 h. However, there was a small increase in conventional laparoscopy patients without statistical signifi cance after 72 h [ 27 ]. Pisanu et al. found no statistical signifi cance between pain scores at 6 h and 24 h post-operatively [ 26 ]. There is moderate level evidence that there are higher pain scores in patients that undergo SILC ( Grade 2B recommendation in favor of MPLC ). There is also variability in the post – operative interval at which the difference in pain scores are reported . Cosmesis, Patient Satisfaction, and Quality of Life Scores There is high variability between studies looking at patient satisfaction, cosmetic scores, and quality of life scores. Leung et al. showed equivalent quality of life scores at 1 week, 3 weeks and 6 months, and satisfaction scores were similar at 3 weeks and 6 months post-operatively [ 19 ]. Trasulli et al. found no signifi cant difference in cosmetic scores in the early post-operative period, but at 3 months and 6 months there was a trend toward improved cosmetic scores in SILC [ 27 ]. Several other studies found slight differences in favor of SILC for cosmetic outcomes [ 26 , 31 ]. There is moderate level evidence demonstrating equivalent results for cosmetic outcomes , patient satisfaction scores , and quality of life scores when comparing SILC with MPLC . ( Grade 1B recommendation that the modalities are similar .) Hernia Rates There are no studies that compare the specifi c outcome variable of incisional hernia rates between SILC and MPLC. Most of the patients are small subsets from randomized studies, with inadequate power to reach statistical signifi cance, even in pooled meta-analysis data. However, there are a few studies demonstrating a signifi cant trend toward an increase in incisional hernia rates following cholecystectomy in the B.R. Luo and N.J. Soper 223 SILC population [ 20 , 27 ]. There are also other studies that show no signifi cant differences between the two groups, but there may not be adequate long term followup to demonstrate a difference [ 18 , 19 , 21 , 23 ]. There is low level evidence suggesting that there may be an increased risk of incisional hernia formation after SILC cholecystectomy ; however , long – term studies are necessary . ( Grade 2C recommendation in favor of MPLC .) Recommendations When compared with multi-port laparoscopic cholecystectomy , SILC has similar morbidity , conversion rates to open surgery , cosmesis , and quality of life . There are small increases in SILC for pain , cost , and possibly rates of post-operative incisional hernia formation. The current recommendation is that MPLC is still the standard of care for patients undergoing elective cholecystectomy . 1. In experienced hands, SILC and MPLC are equivalent with respect to mortality , major complications, and biliary complications (evidence quality high, strong recommendation). 2. SILC is associated with a small increase in minor adverse events, postoperative pain , port site infection, and hernia compared to MPLC (evidence quality low, weak recommendation). 3. Because SILC is more expensive without demonstrable improvement in safety, cosmesis , quality of life , or patient satisfaction, MPLC remains the preferred minimally invasive approach for routine cholecystectomy (evidence quality moderate, strong recommendation). A Personal View of the Data One of the major limitations of all of these studies is the state of the gallbladder pathology itself. To achieve homogenous patients the randomized trials have included only elective gallbladder pathology, usually symptomatic cholelithiasis or gallbladder polyps, without evidence of acute cholecystitis or other more complex conditions. Additional data need to be collected to establish the safety profi le of SILC in acute cholecystitis. Cosmesis is diffi cult to interpret; patients that are more concerned with cosmetic appearance are more likely to seek out a SILC and may be more likely to enroll in a study where they could potentially be randomized to the SILC group, whereas patients who do not place a large emphasis on cosmesis might be more likely to opt out of the randomization. Costs may eventually become more in favor of SILC as dedicated SILS instrumentation is becoming more cost -effective to produce. Post-operative incisional hernia rates can only be truly studied if there is a standardization of technique for SILC platforms, conventional laparoscopic 19 Single-Incision or Multiport Laparoscopic Cholecystectomy 224 access (Hasson versus Veress), and extraction sites (umbilical versus epigastric), and be powered appropriately for this specifi c outcome variable. All of these are variables that can create bias or confounding factors. There also would need to be long term follow-up, but as demonstrated by most of the studies, the drop-out rates can reach up to 20 % even at 1 year post-operatively [ 20 ]. References 1. Ingrahm AM, Cohen ME, Ko CY, Hall BL. A current profi le and assessment of North American cholecystectomy: results from the American College of Surgeons National Surgical Quality Improvement Program. J Am Coll Surg. 2010;211:176–86. 2. Soper NJ. Cholecystectomy: from Langenbuch to natural orifi ce transluminal endoscopic surgery. World J Surg. 2011;35(7):1422–7. 3. Brody F, Vaziri K, Kasza J, Edwards C. Single incision laparoscopic cholecystectomy. J Am Coll Surg. 2010;210(2):e9–13. 4. Valverde A. Single incision laparoscopic cholecystectomy using the SILS monotrocar. J Visc Surg. 2012;149:e38–43. Retrospective Review 5. Podolsky ER, Currillo PG. Single port access (SPA) surgery – a 24 month experience. J Gastrointest Surg. 2010;14:759–67. 6. Rawlings A, Hodgett SE, Matthews BD, et al. Single incision laparoscopic cholecystectomy: initial experience with critical view of safety dissection and routine intraoperative cholangiography. J Am Coll Surg. 2010;211:1–7. 7. Love KM, Durham CA, Meara MP, Mays AC, Bower CE. Single-incision laparoscopic cholecystectomy: a cost comparison. Surg Endosc. 2011;25(5):1553–8. 8. Antoniou SA, Pointner R, Granderath FA. Single-incision laparoscopic cholecystectomy: a systematic review. Surg Endosc. 2011;25:367–77. 9. Beck C, Eakin J, Dettorre R, Renton D. Analysis of perioperative factors and cost comparison of single-incision and traditional multi-incision laparoscopic cholecystectomy. Surg Endosc. 2013;27(1):104–8. 10. Joseph S, Moore BT, Sorensen GB, et al. Single-incision laparoscopic cholecystectomy: a comparison with the gold standard. Surg Endosc. 2011;25:3008–15. 11. Vemulapalli P, Agaba EA, Camacho D. Single incision laparoscopic cholecystectomy: a single center experience. Int J Surg. 2011;9:410–3. 12. Chekan E, Moore M, Hunter TD, Gunnarsson C. Costs and clinical outcomes of conventional single port and micro-laparoscopic cholecystectomy. JSLS. 2013;17(1):30–45. 13. Feinberg EJ, Agaba E, Feinberg ML, Camacho D, Vemulapalli P. Single-incision laparoscopic cholecystectomy learning curve experience seen in a single institution. Surg Laparosc Endosc Percutan Tech. 2012;22:114–7. 14. Hwang HK, Choi SH, Kang CM, Lee WJ. Single-fulcrum laparoscopic cholecystectomy in uncomplicated gallbladder diseases: a retrospective comparative analysis with conventional laparoscopic cholecystectomy. Yonsei Med J. 2013;54(6):1471–7. 15. Hodgett SE, Hernandez JM, Morton CA, et al. Laparoendoscopic single site (LESS) cholecystectomy. J Gastrointest Surg. 2009;13:188–9. B.R. Luo and N.J. Soper 225 Randomized Trials 16. Lai EC, Yang GP, Tang CN, et al. Prospective randomized comparative study of single incision laparoscopic cholecystectomy versus conventional four-port laparoscopic cholecystectomy. Am J Surg. 2011;202(3):254–8. 17. Aprea G, Coppola BE, Guida F, Masone S, Persico G. Laparoendoscopic single site (LESS) versus classic video-laparoscopic cholecystectomy: a randomized prospective study. J Surg Res. 2011;166(2):e109–12. 18. Vilallonga R, Barbaros U, Sumer A, et al. Single-port transumbilical laparoscopic cholecystectomy: a prospective randomized comparison of clinical results of 140 cases. J Minim Access Surg. 2012;8(3):74–8. 19. Leung D, Yetasook AK, Carbray J, et al. Single-incision surgery has higher cost with equivalent pain and quality-of-life scores compared with multiple-incision laparoscopic cholecystectomy: a prospective randomized blinded comparison. J Am Coll Surg. 2012;215(5):702–8. 20. Marks JM, Phillips MS, Tacchino R, et al. Single-incision laparoscopic cholecystectomy is associated with improved cosmesis scoring at the cost of signifi cantly higher hernia rates: 1-year results of a prospective randomized, multicenter, single-blinded trial of traditional multiport laparoscopic cholecystectomy vs single-incision laparoscopic cholecystectomy. J Am Coll Surg. 2013;216(6):1037–47. 21. Pan MX, Jiang ZS, Cheng Y, et al. Single-incision vs three-port laparoscopic cholecystectomy: prospective randomized study. World J Gastroenterol. 2013;19(3):394–8. 22. Deveci U, Barbaros U, Kapakli MS, et al. The comparison of single incision laparoscopic cholecystectomy and three port laparoscopic cholecystectomy: prospective randomized study. J Korean Surg Soc. 2013;85(6):275–82. 23. Garg P, Thakur JD, Singh I, et al. A prospective controlled trial comparing single-incision and conventional laparoscopic cholecystectomy: caution before damage control. Surg Laparosc Endosc Percutan Tech. 2012;22:220–5. 24. Kurpiewski W, Pesta W, Kowalczyk M, et al. The outcomes of SILS cholecystectomy in comparison with classic four-trocar laparoscopic cholecystectomy. Videosurg Miniinv. 2012;7(4):286–93. 25. Lirici MM, Califano AD, Angelini P, Corcione F. Laparo-endoscopic single site cholecystectomy versus standard laparoscopic cholecystectomy: results of a pilot randomized trial. Am J Surg. 2011;202:45–52. Meta-analysis/Systematic Reviews 26. Pisanu A, Reccia I, Porceddu G, Uccheddu A. Meta-analysis of prospective randomized studies comparing single-incision laparoscopic cholecystectomy (SILC) and conventional multiport laparoscopic cholecystectomy (CMLC). J Gastrointest Surg. 2012;16:1790–801. 27. Trastulli S, Cirocchi R, Desiderio J, et al. Systematic review and meta-analysis of randomized clinical trials comparing single-incision versus conventional laparoscopic cholecystectomy. Br J Surg. 2013;100(2):191–208. 28. Qiu J, Yuan H, Chen S, et al. Single-port versus conventional multiport laparoscopic cholecystectomy: a meta-analysis of randomized controlled trials and nonrandomized studies. J Laparoendosc Adv Surg Tech A. 2013;23(10):815–31. 19 Single-Incision or Multiport Laparoscopic Cholecystectomy 226 29. Arezzo A, Scozzari G, Famiglietti F, Passero R, Morino M. Is single-incision laparoscopic cholecystectomy safe? Results of a systematic review and meta-analysis. Surg Endosc. 2013;27(7):2293–304. 30. Gurusamy KS, Vaughan J, Rossi M, Davidson BR. Fewer-than-four ports versus four ports for laparoscopic cholecystectomy (Review). Cochrane Database Syst Rev. 2014;2:CD007109. 31. Milas M, Devedija S, Trkulja V. Single incision versus standard multiport laparoscopic cholecystectomy: up-dated systematic review and meta-analysis of randomized trials. Surgeon. 2014;pii:S1479-666X(14)00015-8.