Solo and Non-solo Approach for Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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To determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).

Detailed Description
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Laporoscopic cholecystectomy usually requires three surgeons, including an operator, a camera assistant, and other instrument assistant. Recent advancement of technology made it possible to develop the conveniently adjustable holders for camera and other laparoscopic instruments. The application of these instruments enables solo-surgery wherein an operation is driven by single surgeon. During surgery, human assistant(s) are helpful because of their instant assistance according to the operation's need. Therefore, the utilization of instruments instead of human assistants would be cumbersome. However, the utilization of instruments would be helpful by enabling operation-driven repositioning of the camera and instrument(s). Currently, no attempt has been made to objectively compare the merits and demerits of these two procedures. Therefore, this study was conducted to determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).

Official Title
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A Randomized Controlled Trial Comparing a Solo and Non-solo Approach for Laparoscopic Cholecystectomy

Conditions
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Cholecystectomy, Laparoscopic

Intervention / Treatment
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* Procedure: nonsolo LC
* Procedure: solo LC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients planed to undergo elective laparoscopic cholecystectomy Benign gallbladder diseases requiring surgery The patients who are indicated for single-port laparoscopic cholecystectomy. Exclusion Criteria: the patients with complicated cholecystitis the patients with the gallbladder with a thickness more than 4mm. the patients who are expected to have severe peritoneal adhesion. the patients with malignant gallbladder diseases. the patients whose operation appears to need human assistant(s)

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: LC & nonsolo approach<br>The surgical intervention is nonsolo LC. | Procedure: nonsolo LC<br>* This patient is scheduled to undergo nonsolo laparoscpic cholecystectomy.<br>* Other names: Nonsolo laparoscopic cholecystectomy;|
| Active Comparator: LC & solo approach<br>The surgical intervention is solo LC. | Procedure: solo LC<br>* This patient is scheduled to undergo solo laparoscpic cholecystectomy.<br>* Other names: Solo laparoscopic cholecystectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | Operation time correlates with surgical difficulity. | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Daily pain scores are assessed. | day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic cholecystectomy, Solo surgery, Camera holder, Cholecystitis