Solo and Non-solo Approach for Laparoscopic Appendectomy (SOLOAP)

Study Overview
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Brief Summary
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To determine the safety and feasibility of solo laparoscopic appendectomy, which is defined as the application of solo surgery to laparoscopic appendectomy, 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 appendectomy 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 appendectomy, which is defined as the application of solo surgery to laparoscopic appendectomy, 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 Appendectomy

Conditions
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Appendicitis, Laparoscopic

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients planned to undergo elective laparoscopic appendectomy Benign gallbladder diseases requiring surgery The patients who are indicated for single-port laparoscopic appendectomy. 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 LA<br>* This patient is scheduled to undergo nonsolo laparoscpic appendectomy.<br>* Other names: Nonsolo laparoscopic appendectomy;|
| Active Comparator: LC & solo approach<br>The surgical intervention is solo LC. | Procedure: solo LA<br>* This patient is scheduled to undergo solo laparoscpic appendectomy.<br>* Other names: Solo laparoscopic appendectomy;|

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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Solo surgery, Camera holder, Laparoscopic Appendectomy