Safety and Cost-effectiveness Study of Single Port Laparoscopic Cholecystectomies

Study Overview
=================
Brief Summary
-----------------
Many feasibility studies have been published on Single Port surgery, but no comparative studies have shown any advantages compared to standard laparoscopy. The purpose of this study is to compare the clinical outcomes and economical issues of laparoscopic cholecystectomies using single port transumbilical approach and three trocars.

Detailed Description
-----------------
Design: Prospective Randomized Controlled trial Population analysis based on Intention To Treat Patient and data analyzer blinded (double-blind trial) Outcomes observed: Primary: pain Secondaries: overall operative time, complication rate, cost-effectiveness analysis, cosmetic evaluation, quality of life, CO2 consumption Nbr of patients included: 260 Port used: Triport, Olympus

Official Title
-----------------
Single Port vs Tree Trocars Laparoscopic Cholecystectomy: a Randomized Controlled Trial

Conditions
-----------------
Cholecystolithiasis

Intervention / Treatment
-----------------
* Procedure: Single Trocar CCK
* Procedure: Standard CCK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cholecystolithiasis Age 18 to 75 y.o. BMI < 35 Exclusion Criteria: Immunodeficiency Choledocholithiasis Previous upperGI open surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SinglePort CCK<br>CCK using Triport | Procedure: Single Trocar CCK<br>* CCK using Triport<br>|
| Active Comparator: LS CCK<br>CCK using three or four trocars | Procedure: Standard CCK<br>* CCK using three or four ports<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (value on a Visual Analog Scale) | VAS | 1 day | 
| Pain (value on a Visual Analog Scale) | VAS | 2 days | 
| Pain (value on a Visual Analog Scale) | VAS | 1 month | 
| Pain (value on a Visual Analog Scale) | VAS | 3 month | 
| Pain (value on a Visual Analog Scale) | VAS | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | In euro | 1 month | 
| Operative time | In euro | Operative day | 
| Cost analysis | In euro | 1 year | 
| Cosmetic results | According to POSAS score | 1 month | 
| Cosmetic results | According to POSAS score | 3 month | 
| Cosmetic results | According to POSAS score | 1 year | 
| Complications | According to Clavien classification and CCI | 3 month | 
| Complications | According to Clavien classification and CCI | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholecystolithiasis, Cholecystectomy, Laparoscopic surgery, Single port