Randomized controlled trial of single incision versus conventional multiport laparoscopic cholecystectomy with long-term follow-up.

BACKGROUND: Within the last years, single-incision laparoscopic cholecystectomy (SLC) emerged as an alternative to multiport laparoscopic cholecystectomy (MLC). SLC has advantages in cosmetic results, and postoperative pain seems lower. Overall complications are comparable between SLC and MLC. However, long-term results of randomized trials are lacking, notably to answer questions about incisional hernia rates, long-term cosmetic impact and chronic pain. METHODS: A randomized trial of SLC versus MLC with a total of 193 patients between December 2009 and June 2011 was performed. The primary endpoint was postoperative pain on the first day after surgery. Secondary endpoints were conversion rate, operative time, intraoperative and postoperative morbidity, technical feasibility and hospital stay. A long-term follow-up after surgery was added. RESULTS: Ninety-eight patients (50.8%) underwent SLC, and 95 patients (49.2%) had MLC. Pain on the first postoperative day showed no difference between the operative procedures (SLC vs. MLC, 3.4 ± 1.8 vs. 3.7 ± 1.9, respectively; p = 0.317). No significant differences were observed in operating time or the overall rate of postoperative complications (4.1% vs. 3.2%; p = 0.731). SLC exhibited better cosmetic results in the short term. In the long term, after a mean of 70.4 months, there were no differences in incisional hernia rate, cosmetic results or pain at the incision between the two groups. CONCLUSIONS: Taking into account a follow-up rate of 68%, the early postoperative advantages of SLC in relation to cosmetic appearance and pain did not persist in the long term. In the present trial, there was no difference in incisional hernia rates between SLC and MLC, but the sample size is too small for a final conclusion regarding hernia rates. TRIAL REGISTRATION: German Registry of Clinical Trials DRKS00012447.

Single-port versus multiport laparoscopic surgery comparing long-term patient satisfaction and cosmetic outcome.

INTRODUCTION: Several studies and meta-analysis showed Single-port or Single-incision laparoscopic surgery (SPL) to be superior over Multiport laparoscopic surgery (MPL) mainly in terms of postoperative pain and cosmetic result. But very little is known whether these results are only a short-term effect or are persistent on the long run after SPL. We therefore evaluated and compared long-term outcomes regarding cosmesis and chronic pain after SPL and MPL. METHODS: We conducted a comparative study with propensity score matching of all patients undergoing SPL or MPL between October 2008 and December 2013 in terms of postoperative cosmetic results and chronic pain. Follow-up data were obtained from mailed patient questionnaires and telephone interviews. Postoperative cosmesis was assessed using the patients overall scar opinion on a 10-point scale and the Patients scale of the standardized Patient and Observer Scar assessment scale (POSAS). Chronic pain was assessed by 10-point scales for abdominal and umbilical scar pain. RESULTS: A total of 280 patients were included in the study with 188 patients (67.1%) after SPL and 92 patients (32.9%) following MPL. 141 patients (50.4%) underwent a cholecystectomy and 139 patients (49.6%) underwent an appendectomy. The mean follow-up time was 61.1 ± 19.1 months. The mean wound satisfaction assed by the overall scar and the PSOAS Patients scale score of the patients showed no significant difference between MPL and SPL. Patients after SPL reported more overall complains than after MPL (8.7% vs. 2.5%, respectively), but without statistical significance (p = 0.321). Umbilical pain scores were comparable between the two groups (1.4 ± 1.0 vs. 1.4 ± 1.0, p = 0.831). CONCLUSION: We found no difference in long-term cosmetic outcomes after SPL and MPL. Chronic pain at the umbilical incision site was comparable on the long run.

Long-term follow-up after single-incision laparoscopic surgery.

BACKGROUND: Single-incision laparoscopic surgery (SILS) is growing in popularity. The increased diameter of the umbilical incision might raise questions about the possibility of a greater risk of postoperative incisional hernia in comparison to conventional laparoscopy. This study aims to disclose the frequency of incisional hernia after SILS in long-term follow-up as well as to reveal the factors predisposing patients to this feared complication. METHODS: The patient collective consists of cholecystectomy and appendectomy patients, who were operated on using SILS technique. Follow-up was achieved through letter correspondence, telephone interview, and clinical examination. Effects of demographic variables and operative parameters including age, sex, BMI, ASA score, duration of surgery, pre-existing hernia as well as postoperative incidence of incisional hernia were investigated using univariate and multivariate analyses. RESULTS: A total of 286 cases with complete follow-up were included in the analyses. Mean follow-up duration was 58.4 months. 192 patients (67.1%) underwent cholecystectomy; 94 (32.9%) had an appendectomy. The study collective consisted of 218 women (76.2%) and 68 men (23.8%). Mean age at the date of the operation was 38.5 (median 36, range 13-74). In 5 cases (1.7%), the surgical approach was converted into conventional laparoscopy. Intraoperative complication rate was 0.3% and postoperative complication rate was 5.9%. 7 patients (2.4%) developed an incisional hernia. Obese patients had an incisional hernia incidence of 10.9%. 3 out of 19 patients (15.8%) with a pre-existing umbilical hernia developed an incisional hernia during follow-up. Obesity and pre-existing umbilical hernia proved to have a significant association with incisional hernia incidence in univariate and multivariate analyses. Sex, age, procedure (appendectomy vs cholecystectomy), presence of acute inflammation, and duration of surgery did not show a statistically significant association with incisional hernia. CONCLUSION: Detection of incisional hernia necessitates a long follow-up duration. Obesity and pre-existing umbilical hernia are associated with a higher incidence of this complication. Following a careful patient selection, SILS offers a safe approach for cholecystectomy and appendectomy procedures.

Safety and Efficiency of Single-Incision Laparoscopic Cholecystectomy in Obese Patients: A Case-Matched Comparative Analysis.

Background: Single-incision laparoscopic surgery (SILS) is feasible and safe for most situations that indicate a need for cholecystectomy in normal-weight patients. SILS might offer several potential benefits over multiport laparoscopy. However, the effect of obesity on the surgical outcomes of single-incision laparoscopic cholecystectomy (SILC) has not been sufficiently investigated and is controversial. The aim of this study was to compare normal-weight and obese patients who had undergone SILC. Methods: All single-incision laparoscopic cholecystectomies performed between December 2008 and December 2014 were reviewed and grouped according to patient's body mass index (BMI). Obese patients with a BMI ≥30 kg/m2 who had undergone SILC were matched in a 1:2 ratio with non-obese patients. Results: One hundred six obese patients after SILC were compared with 212 non-obese patients according to age, gender, and indication for operation. Operation in obese patients was longer but without significant difference (53.9 minutes versus 62.3 minutes; P = .189). In each group, 4 patients needed conversion to multiport laparoscopy or open procedure (1.9% versus 3.8% for non-obese versus obese; P = .236). No significant difference was noted for postoperative complications (4.3% versus 5.7% for non-obese versus obese; P = .790) and the length of hospital stay (3.3 days versus 3.3 days; P = .958). Obese patients have a significantly (P = .027) higher incisional hernia rate (9.8%) than non-obese patients (1.9%), with obesity being a risk factor for hernia development in the univariate analysis. Conclusion: SILC in obese patients is technically feasible and safe compared with non-obese patients in regard to postoperative complications, conversion rates, and length of hospital stay but with an almost sixfold risk of umbilical incisional hernia on the long run.