Is single–incision laparoscopic cholecystectomy ready for prime time?

Letters to the Editor First of all, I would like to apologize for discrepancies between the study protocols mentioned in the ClinicalTrials. gov and the article. Honestly, ClinicalTrials.gov was relatively new and fairly complicated tool for the authors when the study was being conducted, and the authors have recently been accustomed to the use of ClinicalTrials.gov. Nevertheless, the corrections will be made as soon as possible. The ‘‘enhanced recovery after surgery’’ protocol was never meant to reduce the morbidity and mortality rate. We agree. Likewise, the rationale beneath using the morbidity and mortality rate as primary end points along with the length of hospital stay was not to investigate whether our protocol would reduce these rates or not but was rather to find out whether our protocol would increase these rates or not. In this respect, if a decrease in the morbidity and mortality rate had been found in our study, it would have been irrelevant but surprising. In a clinical research trial, a primary end point refers to occurrence of a disease, symptom, sign, or laboratory abnormality that constitutes one of the target outcomes of the trial but may also refer to any such disease or sign that strongly motivates the withdrawal of that individual or entity from the trial. According to this definition, the morbidity and mortality rate should have been primary end points in our study because the trial would have been discontinued if an increase in the morbidity and mortality rate had been suspected or observed. The length of hospital stay was not the only primary end point. Thirty-day morbidity and mortality were the other primary end points in the study. Thus, the patient who was lost to follow-up before the end of 30th day after surgery,

367 had to be excluded. Patients in group 1 who unintentionally removed their nasogastric tubes immaturely were excluded because the study was not an intention-to-treat but a perprotocol analysis. In contrast to Dr. Søreide, I believe that the title exactly fits the trial. The study group might be considered a representative population for most cases with generalized peritonitis such as complicated appendicitis, hollow viscus perforation, and so forth in terms of clinical means. Should early removal of nasogastric tube and early initiation of oral intake is demonstrated to be feasible and safe in patients with generalized peritonitis even with a freshly repaired perforation in the upper gastrointestinal tract, then these application may be considered for aforementioned conditions. As Dr. Søreide mentioned; however, high-risk surgical patients were excluded from the study because this was meant to be a pilot study. Having confirmed the feasibility and safety of this protocol, we integrate the protocol in our practice and began to apply it to high-risk patients as well. Likewise, we will report the outcomes of all patients including the high-risk ones in the future. Finally, I would like to thank Dr. Søreide for sharing the true history of the omental patch repair with us. Murat Gonenc, M.D. General Surgery Clinics, Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey http://dx.doi.org/10.1016/j.amjsurg.2015.12.032

Is single–incision laparoscopic cholecystectomy ready for prime time? To the Editor I find it interesting in reading the article ‘‘Is routine single–incision laparoscopic cholecystectomy feasible? A retrospective observational study by Shu-Hung Chuang.1 The data presented were indeed very unique and homogenous one from a single surgeon of a single institute. SILC has been practiced selectively almost for the last 2 decades since Navarra G. first reported in 1997,2 and there were several systemic reviews and meta-analysis comparing the outcomes of SILC vs conventional laparoscopic cholecystectomy in treating benign gall bladder diseases in the literature recently.3–6 All data so far are suggesting that only marginal benefits of cosmesis and the reduction of the postoperative wound pain of SILC over conventional laparoscopic cholecystectomy have been proved, and not even to mention a few more disadvantages either. ‘‘Twenty-six (13%) procedures were converted, including 12 two incision LCs, 5 three-incision LCs, 8 four-incision LCs, and 1 open cholecystectomy’’ were noted in Chuang’s article.1 The conversion rate of conventional LC (multiport) to open cholecystectomy and SILC to conventional LC would be

probably less than 5% and 10% respectively.7 In fact, if all the cases in this series were done in conventional LC fashion rather than SILC, then there would be only 1 case required to be converted, to open cholecystectomy and for the rest of the other 25 cases conversion could be avoided altogether. Therefore, the necessity of learning SILC just to ‘‘achieve competency for its use in complicated disease’’1 although feasible, is probably neither warranted nor worthwhile. Brian P. Hung, M.D. Department of General Surgery, Cardinal Tien Hospital, New Taipei City, Taiwan http://dx.doi.org/10.1016/j.amjsurg.2015.09.024

References 1. Chuang SH, Yang WJ, Chang CM, et al. Is routine single -incision laparoscopic cholecystectomy feasible? A retrospective observational study. Am J Surg 2015;210:315–21.

368 2. Navarra G, Pozza E, Occhionjr S, et al. One-wound laparoscopic cholecystectomy. Br J Surg 1997;84:695. 3. Markar S, Karthikesalingam A, Thrumurthy S, et al. Single-incision laparoscopic surgery (SILS) vs conventional multiport cholecystectomy: systemic review and meta-analysis. Surg Endosc 2012;26:1205–13. 4. Garg P, Thakur JP, Garg M, et al. Single-incision laparoscopic cholecystectomy vs. conventional laparoscopic cholecystectomy: a meta-analysis of randomized controlled trials. J Gastrointest Surg 2012;16:1618–28.

The American Journal of Surgery, Vol 212, No 2, August 2016 5. Trastulli S, Cirocchi R, Desiderio J, et al. Systematic review and metaanalysis of randomized clinical trials comparing single-incision versus conventional laparoscopic cholecystectomy. Br J Surg 2013;100:191–208. 6. Li L, Tian J, Tian H, et al. The efficacy and safety of different kinds of laparoscopic cholecystectomy: a network meta analysis of 43 randomized controlled trials. PLos One 2014;9:e90313. 7. Ross S, Rosemurgy A, Albrink M, et al. Consensus statement of the consortium for LESS cholecystectomy. Surg Endosc 2012;26:2711–6.

Emergency admissions in patients that have undergone bariatric surgerydthe experience from a UK district general hospital We read with interest the experience of Bradley et al1 in a US quaternary care hospital of bariatric surgery complications presenting to the acute care surgeon. We have noted similar findings in the UK. We recently undertook a retrospective observational study in a geographically isolated district general hospital on emergency admissions of patients who have previously had bariatric surgery over a 5-year period. Fifty-three cases from 54 episodes of presentation were identified. They were aged 44.68 6 1.57 (mean 6 standard error of the mean), with male-female ratio of 12:42 and length of stay 4.67 6 4.75 (median 6 standard deviation). The previous bariatric procedures were Roux-en-Y gastric bypass (57%), laparoscopic adjustable gastric band (24%), laparoscopic sleeve gastrectomy (9%), laparoscopic sleeve gastrectomy to Roux-en-Y gastric bypass (8%), and intragastric balloon (2%). Most were managed nonoperatively with intervention required in one-fifth of these patients. They were as follows: gastrectomy for gastric-band erosion, removal of foreign body, exploration of suture sinus and laying open wound, laparoscopy and fluid suction, incision and drainage of abdominal wall and removal of mesh, laparoscopic appendicectomy, epigastric hernia, incision and draining of ischiorectal abscess, removal of Hickman line, and repair of port site hernia with bowel resection. We noted that the frequency of admissions significantly increased from n 5 16 in 2010–2011, to n 5 30 admissions in 2012–2013, P 5 .0026. Until 2013, there were no bariatric surgeons at Scarborough General Hospital, and these were managed by nonbariatric surgeons. Specialty of admitting surgeons were most commonly colorectal (n 5 44), followed by vascular (n 5 7), breast (n 5 2) and upper

gastrointestinal (n 5 1). Two cases were transferred to a specialist center. Our findings were presented at the 5th Annual Scientific Meeting of the British Obesity & Metabolic Surgery Society in 2014,2 and the overall feedback consensus was that most nonbariatric surgeons felt overwhelmed when faced with postbariatric surgical emergencies or dealing with surgical emergencies in patients who have had bariatric surgery. Here, the question was posed should hospitals that do not have local bariatric expertise, have a formalized understanding with nearby centers whether it be an outreach or in-reach service? Our findings suggest that this is becoming an increasingly common place challenge. Tanvir Hossain, D.M., M.R.C.S. Mark B. Peter, M.D., F.R.C.S. Sunjay Kanwar, F.R.C.S. Robert Macadam, Ph.D., F.R.C.S. Department of General Surgery Scarborough General Hospital York Teaching Hospital NHS Foundation Trust Scarborough, United Kingdom http://dx.doi.org/10.1016/j.amjsurg.2015.07.036

References 1. Bradley 3rd JF, Ross SW, Christmas AB, et al. Complications of bariatric surgery: the acute care surgeon’s experience. Am J Surg 2015;210:456–61. 2. Hossain T, McNaught C, Gheorghiu S, et al. Emergency admissions in patients that have undergone bariatric surgerydare we prepared for the inevitable? BJS 2014;101:1–22.