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.

Single-incision versus multiport laparoscopic appendectomy: a case-matched comparative analysis.

BACKGROUND: The multiport technique is the gold standard for laparoscopic appendectomy, but the use of single-incision laparoscopy is on the increase. The aim of the present study was to compare case-matched cohorts of patients who had undergone single-incision laparoscopic appendectomy (SILA) with those who had undergone conventional multiport laparoscopic appendectomy (MLA). METHODS: In a case-matched analysis, all single-incision laparoscopic appendectomies performed between July 2009 and December 2013 at one institution were reviewed and compared to multiport laparoscopic appendectomies performed during the same period. Patients who had undergone SILA were matched in terms of age, gender, body mass index (BMI), and American Society of Anesthesiologists (ASA) scores with the same number of patients who had undergone MLA. Statistical evaluation included the description and comparison of demographic factors, details of surgery, and histological data. A univariate analysis was performed to assess potential risk factors for morbidity after SILA. RESULTS: One hundred and fifty-six patients who had undergone SILA were reviewed, matched, and compared to the same number of patients who had undergone MLA. No significant difference was noted in mean operating times (50.83 vs. 50.61 min for SILA and MLA, respectively; p = 0.924) and the length of hospital stay (3.60 vs. 3.66 days; p = 0.704). No patient in either group required conversion to the open procedure while 6 (3.8 %) SILA patients were converted to multiport laparoscopy. SILA was not associated with significantly higher postoperative morbidity compared to MLA (9.6 % vs. 5.8 %; p = 0.288). Postoperative wound infection rates were higher after SILA (3.2 % vs. 0.6 %), but did not achieve statistical significance (p = 0.214). Statistical analysis revealed no risk factors for developing postoperative complications after the single-incision procedure. CONCLUSION: SILA is a technically feasible and safe alternative to conventional MLA. The two procedures did not differ in terms of operating times, length of hospital stay, and postoperative outcomes.

Single-Incision Cholecystectomy in about 200 Patients.

Background and Aims. We describe our experience of performing transumbilical single-incision laparoendoscopic cholecystectomy as standard procedure for acute and chronic gallbladder diseases. Methods. Between September 2008 and March 2010, 220 patients underwent laparoscopic single-incision surgery. A single port was used for 196 patients and two conventional 5 mm and one 10 mm port in 24 cases. All operations were performed with straight instruments. Results. Single-incision surgery was successfully performed in 215 patients (98%). Three patients (1.4%) required conversion to a three-port technique and two patients (0.9%) to an open procedure. Average age of 142 women (65%) and 78 men (35%) was 47 years (range: 15-89), average ASA status 2 (range: 1-3) and BMI 28 (range: 15-49). Mean operative time was 62 minutes (range: 26-174) and 57 patients (26%) had histopathological signs of acute cholecystitis. Eleven patients (5%) developed to surgery-related complications and nine (4%) of these required a reoperation. The mean followup was 331.5 (range: 11-590) days. Conclusion. Transumbilical single-incision cholecystectomy is a feasible and safe new approach for routine cholecystectomy. After a short learning curve, operation time and complication rate are comparable with standard multiport operation. In addition, most cases of acute cholecystitis can be performed with this technique.

Single-port versus multi-port cholecystectomy for patients with acute cholecystitis: a retrospective comparative analysis.

BACKGROUND: Trans-umbilical single-port laparoscopic cholecystectomy for chronic gallbladder disease is becoming increasingly accepted worldwide. But so far, no reports exist about the challenging single-port surgery for acute cholecystitis. The objective of this study was to describe our experience with single-port cholecystectomy in comparison to the conventional laparoscopic technique. METHODS: Between August 2008 and March 2010, 73 patients with symptomatic gallbladder disease and histopathological signs of acute cholecystitis underwent laparoscopic cholecystectomy at our institution. Thirty-six patients were operated on with the single-port technique (SP group) and the data were compared with a control group of 37 patients who were treated with the multi-port technique (MP group). RESULTS: The mean age in the SP group was 61.5 (range 21-81) years and in the MP group was 60 (range 21-94) (P=0.712). Gender, ASA status and BMI were not significantly different. The number of white blood cells was different before [SP: 9.2 (range 2.8-78.4); MP: 13.2 (range 4.4-28.6); P=0.001] and after the operation [SP: 7.8 (range 3.5-184.8); MP: 11.1 (range 5-20.8); P=0.002]. Mean operating time was 88 (range 34-174) minutes in the SP group vs 94 (range 39-209) minutes in the MP group (P=0.147). Four patients (5%) required conversion to an open procedure (SP: 1; MP: 3; P=0.320). During the follow-up period of 332 (range 29-570) days in the SP group and 428 (range 111-619) days in the MP group (P=0.044), eleven (15%) patients developed postoperative complications (P=0.745) and two patients in the SP group required reoperation (P=0.154). CONCLUSIONS: Trans-umbilical single-port cholecystectomy for beginning acute cholecystitis is feasible and the complication rate is comparable with the standard multi-port operation. In spite of our good results, these operations are difficult to perform and should only be done in high-volume centers for laparoscopic surgery with experience in single-port surgery.

Initial experience in laparoscopic single-port appendectomy: a pilot study.

BACKGROUND: We describe our initial experience performing a single-port (SP) advanced laparoscopic appendectomy in comparison to the conventional port (CP) technique, which uses three ports. METHODS: Between June and September 2009, 40 consecutive patients with acute appendicitis underwent laparoscopic appendectomy at Vivantes Klinikum Am Urban, Berlin, Germany. Twenty patients were operated on using the SP technique (SP group), and the data were compared to a control group of 20 patients operated on using the CP technique (CP group) during the same time period. RESULTS: SP surgery was successfully performed on all patients without conversion to CP laparoscopic appendectomy or an open procedure. The mean age was 27.7 ± 8.3 years in the SP group and 31.7 ± 9.3 in the CP group (p = 0.32). Gender (p = 0.352), status of the American Society of Anesthesiologists (p = 0.765) and body mass index (p = 0.971) did not differ significantly between the two groups. The mean operating time was 48.0 ± 13.2 min in the SP group versus 49.0 ± 19.9 min in the CP group (p = 0.694). No patient in the SP group developed surgical complications. No patient in either group developed an incisional hernia or wound infection during the mean follow-up of 98.17 ± 38.56 days. CONCLUSION: Transumbilical SP appendectomy via a tri-port system with a single incision is a feasible and safe new approach for routine appendectomy. It is easy to perform and good training for more advanced SP surgery.

Treatment of postoperative ileus with choline citrate--results of a prospective, randomised, placebo-controlled, double-blind multicentre trial.

OBJECTIVES: This was a prospective, randomised, placebo-controlled, double-blind multicentre trial to analyse the efficacy of choline citrate in patients with postoperative ileus (POI) after elective colorectal surgery. METHODS: From October 2005 until June 2008, 122 patients with POI were randomised to receive choline citrate or placebo. One hundred twenty patients were evaluable for tolerability and 107 patients were evaluable for efficacy. The treatment group, 47% (50/107), received 300.2 mg choline citrate intravenously, while the placebo group, 53% (57/107), received sodium chloride. Injections were performed every 12 h until defecation. RESULTS: Demographic data analysis did not show clinically differences between both groups. Operative procedures included 40% (43/107) hemicolectomy, 38% (41/107) sigmoid resection and 22% (23/107) other colorectal resections. Defecation occurred after an average of 91.8 ± 26.6 h postoperatively in the treatment group, vs. 96.7 ± 35.2 h in the placebo group (p = 0.805). After laparoscopy, defecation occurred after 78.7 ± 25.3 h, vs. 99.2 ± 31.6 h after laparotomy (p = 0.001). Serious adverse effects occurred in 2% (1/60) in the treatment group, vs. 3% (2/60) in the placebo group. None of the events have been assessed as related to the study medication. CONCLUSION: An efficacy of choline citrate in the treatment of POI after elective colorectal surgery could not be verified. The problem of POI requiring drug treatment seems to be less frequent than suggested by the literature. With technical advances in surgery, especially laparoscopic and fast track surgery, the frequency of POI will further decrease in the future.