Solo Single Incision Laparoscopic Cholecystectomy

Status Not yet recruiting

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03018964
Study type	Interventional
Source	Seoul National University Hospital
Contact	YoungRok Choi, M.D.
Phone	+821093212477
Email	choiyoungrok@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	March 2020
Completion date	August 2022

View Details

See also
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