NCT03018964

Solo Single Incision Laparoscopic Cholecystectomy

A Prospective Multicenter Randomized Controlled Study for The Safety of Single Incision Laparoscopic Cholecystectomy With a Camera Holder Versus With a Camera Operator

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 272 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine safety of solo surgery in single incision laparoscopic cholecystectomy (SILC) with a camera holder comparing to a camera operator assisted SILC

Detailed description

This study is a multicenter randomized controlled study. The primary outcome based on non-inferior study design(α=0.05, power (1-β)=0.90); comparing a complications rate between Solo-SILC group and conventional cholecystectomy group (Ca-SILC). Total of 272 patients who were undergoing laparoscopic cholecystectomy for gallbladder disorders will randomly assign to two groups according to a computer-generated table of random numbers Solo-SILC group using a laparoscopic camera holder (n=136) or Ca-SILC group in which a camera operator joins (n=136). . Demographics (i.e., age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, indication for operation, need for conversion to open surgery or additional port will be recorded. Outcome including pain, hernia, complication rates, post-cholecystectomy diarrhea, operator's workload will be investigated

Conditions

• Cholecystectomy, Laparoscopic

Interventions

Type	Name	Description
PROCEDURE	Solo surgery	Solo surgery using a camera scope holder in single incision laparoscopic cholecystectomy
PROCEDURE	operation with a camera operator in SILC	conventional single incision laparoscopic cholecystectomy with a scopist

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-01-01
• Completion: 2022-08-01
• First posted: 2017-01-12
• Last updated: 2019-04-04