Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
Background: Single port access surgery is a rapidly progressing surgical approach which allows performance of standard laparoscopic surgery through a single transparietal port instead of multiple port accesses. Objective: Demonstrate the validity of Single port access (SPA) cholecystectomy compared to multiple ports laparoscopic cholecystectomy. Hypothesis: SPA cholecystectomy is associated with decreased parietal and body image trauma compare to multiple ports laparoscopic cholecystectomy. SPA cholecystectomy should be associated with better cosmetic results, may improve postoperative recovery due to lower parietal pain. SPA cholecystectomy may also be associated with decreased rate of parietal complications as lower numbers of transparietal port are placed. Methods: All patients offered cholecystectomy, either SPA or multiport cholecystectomy, included in the study will have recognized biliary pathology for which formal indication cholecystectomy are recognized internationally. Surgical technique, either for SPA cholecystectomy or for multiple ports cholecystectomy, will be the same except, that one surgical technique is achieved through a single transparietal port and the other through multiple ports. Randomization will be performed before surgeries after patients have given their informed consent to the study. No specific test or cost will be necessitated by the study. Patients will be informed orally and will receive a short study summary, allowing them to give an informed consent. Endpoints: Morbidity Body image and Cosmetic results Post-operative pain (opioid sparing effect) Operative time Hospital stay

Official Title
-----------------
Single Port Access Cholecystectomy Versus Standard Laparoscopic Cholecystectomy - Randomized Study

Conditions
-----------------
Symptomatic Gallbladder Stones, Cholecystitis, Biliary Pancreatitis

Intervention / Treatment
-----------------
* Procedure: SPA cholecystectomy
* Procedure: Laparoscopic cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 18 years Exclusion Criteria: Contraindication to laparoscopy Liver disease Cognitive trouble

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>SPA cholecystectomy | Procedure: SPA cholecystectomy<br>* SPA cholecystectomy<br>|
| Other: 2<br>laparoscopic cholecystectomy | Procedure: Laparoscopic cholecystectomy<br>* Laparoscopic cholecystectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmesis, body image and quality of life scale |  | at 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative morbidity |  | at 30 days | 
| Post-operative pain |  | 10 days | 
| Operative time |  | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Single port access, Laparoscopy, cholecystectomy, cholangiography, cosmesis