Solo Single Incision Laparoscopic Cholecystectomy

Not Applicable

• Conditions: Cholecystectomy, Laparoscopic
• Interventions: Procedure: Solo surgery; Procedure: operation with a camera operator in SILC

• Registration Number: NCT03018964
• Lead Sponsor: Seoul National University Hospital

Brief 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

Study Timeline

• Study First Submitted: 2017-01-08
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04
• Study Start: 2020-03
• Primary Completion: 2021-01
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 272

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Solo-SILC	Solo surgery	Solo surgery using a laparoscopic camera holder instead of a camera operator in SILC
Ca-SILC	operation with a camera operator in SILC	No solo surgery, operation with a camera operator in SILC

Primary Outcome Measures

Name	Time	Method
Complication rate in Solo-Single Incision Laparoscopic Cholecystectomy (SILC)	average 2 weeks	intraoperative and immediate postoperative complications in Solo-SILC comparing with that in laparoscopic cholecystectomy

Secondary Outcome Measures

Name	Time	Method
Postoperative adverse symptoms after SILC	average 2weeks after discharge	Diet change, post-cholecystectomy diarrhea
number of participant with abnormal laboratory values	average 2weeks after discharge	postoperative laboratory findings on visiting outpatient's clinic
Wound, back, and shoulder pain	postoperative 6 hr, 24 hr, 2 weeks after the operation	Access the patient's pain using the visual analog scale
Operator's workload	intraoperative	Access a operator's workload just after solo surgery comparing to Ca-SILC group using NASA Task Load Index (NASA-TLX) score
complications in both groups	average 2 weeks	intraoperative and postoperative complications
Conversion rate	intraoperative	intraoperative conversion rate to open or additional port surgery
Incisional hernia	average 6 months	Umbilical incisional hernia incidence