Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy

Sponsor

University Hospital, Geneva (Other)

Overall Status

Unknown status

CT.gov ID

NCT00904865

Collaborator

(none)

200

Enrollment

Location

Arms

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Symptomatic Gallbladder Stones Cholecystitis Biliary Pancreatitis	Procedure: SPA cholecystectomy Procedure: Laparoscopic cholecystectomy	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Single Port Access Cholecystectomy Versus Standard Laparoscopic Cholecystectomy - Randomized Study

Study Start Date :

Feb 1, 2009

Anticipated Primary Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 SPA cholecystectomy	Procedure: SPA cholecystectomy SPA cholecystectomy
Other: 2 laparoscopic cholecystectomy	Procedure: Laparoscopic cholecystectomy Laparoscopic cholecystectomy

Arm

Intervention/Treatment

Other: 1

SPA cholecystectomy

Procedure: SPA cholecystectomy

SPA cholecystectomy

Other: 2

laparoscopic cholecystectomy

Procedure: Laparoscopic cholecystectomy

Laparoscopic cholecystectomy