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The comparison of single incision laparoscopic cholecystectomy and three port laparoscopic cholecystectomy: prospective randomized study.

ABSTRACT: PURPOSE:Laparoscopic techniques have allowed surgeons to perform complicated intra-abdominal surgery with minimal trauma. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. In this study we aimed to compare results of SILS cholecystectomy and three port conventional laparoscopic (TPCL) cholecystectomy prospectively. METHODS:In this prospective study, 100 patients who underwent laparoscopic cholecystectomy for gallbladder disease were randomly allocated to SILS cholecystectomy (group 1) or TPCL cholecystectomy (group 2). Demographics, pathologic diagnosis, operating time, blood loss, length of hospital stay, complications, pain score, conversion rate, and satisfaction of cosmetic outcome were recorded. RESULTS:Forty-four SILS cholesystectomies (88%) and 42 TPCL cholecystectomies (84%) were completed successfully. Conversion to open surgery was required for 4 cases in group 1 and 6 cases in group 2. Operating time was significantly longer in group 1 compared with group 2 (73 minutes vs. 48 minutes; P < 0.05). Higher pain scores were observed in group 1 versus group 2 in postoperative day 1 (P < 0.05). There was higher cosmetic satisfaction in group 1 (P < 0.05). CONCLUSION:SILS cholecystectomy performed by experienced surgeons is at least as successful, feasible, effective and safe as a TPCL cholecystectomy. Surgeons performing SILS should have a firm foundation of advanced minimal access surgical skills and a cautious, gradated approach to attempt the various procedures. Prospective randomized studies comparing single access versus conventional multiport laparoscopic cholecystectomy, with large volumes and long-term follow-up, are needed to confirm our initial experience. (ClinicalTrials.gov Identifier: NCT01772745.).

SUBMITTER: Deveci U

PROVIDER: S-EPMC3868679 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature

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The comparison of single incision laparoscopic cholecystectomy and three port laparoscopic cholecystectomy: prospective randomized study.

Deveci Ugur U Barbaros Umut U Kapakli Mahmut Sertan MS Manukyan Manuk Norayk MN Simşek Selçuk S Kebudi Abut A Mercan Selçuk S

Journal of the Korean Surgical Society 20131126 6

<h4>Purpose</h4>Laparoscopic techniques have allowed surgeons to perform complicated intra-abdominal surgery with minimal trauma. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. In this study we aimed to compare results of SILS cholecystectomy and three port conventional laparoscopic (TPCL) cholecystectomy prospectively.<h4>Methods</h4>In this prospective study, 100 patients who underwent laparoscopic cholecystectom ...[more]

PMID: 24368985

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Project description:Recent advances in robotic technology suggest that the utilization of the da Vinci Single-Site™ platform for cholecystectomy is safe, feasible and results in a shorter learning curve compared to conventional single-incision laparoscopic cholecystectomy. Moreover, the robot-assisted technology has been shown to reduce the surgeon's stress load compared to standard single-incision laparoscopy in an experimental setup, suggesting an important advantage of the da Vinci platform. However, the above-mentioned observations are based solely on case series, case reports and experimental data, as high-quality clinical trials to demonstrate the benefits of the da Vinci Single-Site™ cholecystectomy have not been performed to date.This study addresses the question whether robot-assisted Single-Site™ cholecystectomy provides significant benefits over single-incision laparoscopic cholecystectomy in terms of surgeon's stress load, while matching the standards of the conventional single-incision approach with regard to peri- and postoperative outcomes. It is designed as a single centre, single-blinded randomized controlled trial, which compares both surgical approaches with the primary endpoint surgeon's physical and mental stress load at the time of surgery. In addition, the study aims to assess secondary endpoints such as operating time, conversion rates, additional trocar placement, intra-operative blood loss, length of hospital stay, costs of procedure, health-related quality of life, cosmesis and complications. Patients as well as ward staff are blinded until the 1st postoperative year. Sample size calculation based on the results of a previously published experimental setup utilizing an estimated effect size of surgeon's comfort of 0.8 (power of 0.8, alpha-error level of 0.05, error margin of 10-15%) resulted in a number of 30 randomized patients per arm.The study is the first randomized controlled trial that compares the da Vinci Single Site™ platform to conventional laparoscopic approaches in cholecystectomy, one of the most frequently performed operations in general surgery.This trial is registered at clinicaltrials.gov (trial number: NCT02485392 ). Registered February 19, 2015.

Project description:Emerging attempts have been made to reduce operative trauma and improve cosmetic results of laparoscopic cholecystectomy. There is a trend towards minimizing the number of incisions such as natural transluminal endoscopic surgery (NOTES) and single-port laparoscopic cholecystectomy (SPLC). Many retrospective case series propose excellent cosmesis and reduced pain in SPLC. As the latter has been confirmed in a randomized controlled trial, patient's satisfaction on cosmesis is still controversially debated.The SPOCC trial is a prospective, multi-center, double blinded, randomized controlled study comparing SPLC with 4-port conventional laparoscopic cholecystectomy (4PLC) in elective surgery. The hypothesis and primary objective is that patients undergoing SPLC will have a better outcome in cosmesis and body image 12 weeks after surgery. This primary endpoint is assessed using a validated 8-item multiple choice type questionnaire on cosmesis and body image. The secondary endpoint has three entities: the quality of life 12 weeks after surgery assessed by the validated Short-Form-36 Health Survey questionnaire, postoperative pain assessed by a visual analogue scale and the use of analgesics. Operative time, surgeon's experience with SPLC and 4PLC, use of additional ports, conversion to 4PLC or open cholecystectomy, length of stay, costs, time of work as well as intra- and postoperative complications are further aspects of the secondary endpoint. Patients are randomly assigned either to SPLC or to 4PLC. Patients as well as treating physicians, nurses and assessors are blinded until the 7th postoperative day. Sample size calculation performed by estimating a difference of cosmesis of 20% (alpha = 0.05 and beta = 0.90, drop out rate of 10%) resulted in a number of 55 randomized patients per arm.The SPOCC-trial is a prospective, multi-center, double-blind, randomized controlled study to assess cosmesis and body image after SPLC.(clinicaltrial.gov): NCT 01278472.

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The comparison of single incision laparoscopic cholecystectomy and three port laparoscopic cholecystectomy: prospective randomized study.

Publications

The comparison of single incision laparoscopic cholecystectomy and three port laparoscopic cholecystectomy: prospective randomized study.

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