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

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

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

intraoperative and immediate postoperative complications in Solo-SILC comparing with that in laparoscopic cholecystectomy

Access a operator's workload just after solo surgery comparing to Ca-SILC group using NASA Task Load Index (NASA-TLX) score

Inclusion Criteria: all patient need laparoscopic cholecystectomy (check the possibility of routine application of Solo-SILC in clinical practice) Exclusion Criteria: Mirizzi syndrome unstable vital sign no compliance no consent

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