Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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This study will compare Single Incision Laparoscopic Surgery (SILS) cholecystectomy to traditional laparoscopic cholecystectomy (LC), focusing on patient-reported outcomes and cost.

Detailed Description
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Single-Incision Laparoscopic Surgery (SILS) is accepted as a form of surgical treatment. Traditional laparoscopic cholecystectomy (TLC) is well tolerated, with a low complication risk and high patient satisfaction; thus a SILS procedure needs to be at least equivalent to be a justifiable replacement, and should not result in higher costs.

Official Title
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Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy: A Randomized Prospective Trial

Conditions
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Biliary Dyskinesia, Gallstones, Cholecystitis, Cholelithiasis

Intervention / Treatment
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* Procedure: Single-Incision Laparoscopic Surgery cholecystectomy
* Procedure: Traditional Laparoscopic Cholecystectomy (TLC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient recommended to undergo cholecystectomy Patient age 18-80 Patient competent to give his/her own informed consent Patient speaks English without the need for an interpreter Exclusion Criteria: Additional procedures planned during same surgery Patient deemed inappropriate for TLC or SILS cholecystectomy

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: Single-Incision Laparoscopic Cholecsytectomy (SILS)<br> | Procedure: Single-Incision Laparoscopic Surgery cholecystectomy<br>* Laparoscopic Cholecystectomy<br>|
| Active Comparator: Traditional Laparoscopic Cholecystectomy (TLC)<br> | Procedure: Traditional Laparoscopic Cholecystectomy (TLC)<br>* Laparoscopic Cholecystectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost associated with performance of the procedure and post-operative care until discharge |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scale reported by patient at discharge, 24 and 48 hours |  | 24 hours and 48 hours | 
| Amount of pain medicine required during 48 hours after surgery |  | 48 hours | 
| Major and minor gastrointestinal surgical complications, including conversion |  | 4 weeks | 
| Quality of Life |  | 2 weeks and 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic cholecystectomy, Quality of life, Biliary Cholic, Chronic Cholecystitis, Symptomatic Cholelithiasis