Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy

Cholecystitis Clinical Trial

Official title: Single Port Access Cholecystectomy Versus Standard Laparoscopic Cholecystectomy - Randomized Study

Status Recruiting

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Pancreatitis
• Cholecystitis
• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Pancreatitis
• Symptomatic Gallbladder Stones

• NCT number: NCT00904865
• Study type: Interventional
• Source: University Hospital, Geneva
• Contact: Pascal Bucher, MD
• Phone: +41223723311
• Email: pascal.bucher@hcuge.ch
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 2009