Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy

Phase 2

• Conditions: Biliary Pancreatitis; Cholecystitis; Symptomatic Gallbladder Stones
• Interventions: Procedure: SPA cholecystectomy; Procedure: Laparoscopic cholecystectomy

• Registration Number: NCT00904865
• Lead Sponsor: University Hospital, Geneva

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Status Verified: 2009-05
• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-19
• Last Update Submitted: 2009-05-19
• Study First Posted: 2009-05-20
• Last Update Posted: 2009-05-20
• Primary Completion: 2011-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age more than 18 years

Exclusion Criteria

• Contraindication to laparoscopy
• Liver disease
• Cognitive trouble

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	SPA cholecystectomy	SPA cholecystectomy
2	Laparoscopic cholecystectomy	laparoscopic cholecystectomy

Primary Outcome Measures

Name	Time	Method
Cosmesis, body image and quality of life scale	at 1 month

Secondary Outcome Measures

Name	Time	Method
Post-operative morbidity	at 30 days
Post-operative pain	10 days
Operative time	day 1

Trial Locations

Locations (1)

University Hospital Geneva; 🇨🇭 Geneva, Switzerland