Solo Single Incision Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Cholecystectomy, Laparoscopic

Intervention / Treatment
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* Procedure: Solo surgery
* Procedure: operation with a camera operator in SILC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Solo-SILC<br>Solo surgery using a laparoscopic camera holder instead of a camera operator in SILC | Procedure: Solo surgery<br>* Solo surgery using a camera scope holder in single incision laparoscopic cholecystectomy<br>|
| Active Comparator: Ca-SILC<br>No solo surgery, operation with a camera operator in SILC | Procedure: operation with a camera operator in SILC<br>* conventional single incision laparoscopic cholecystectomy with a scopist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate in Solo-Single Incision Laparoscopic Cholecystectomy (SILC) | intraoperative and immediate postoperative complications in Solo-SILC comparing with that in laparoscopic cholecystectomy | average 2 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single incision, Solo surgery