Brief Title
Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy
Official Title
Single Port Access Cholecystectomy Versus Standard Laparoscopic Cholecystectomy - Randomized Study
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
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Cosmesis, body image and quality of life scale
Secondary Outcome
Post-operative morbidity
Condition
Symptomatic Gallbladder Stones
Intervention
SPA cholecystectomy
Study Arms / Comparison Groups
1
Description: SPA cholecystectomy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
200
Start Date
February 2009
Primary Completion Date
February 2011
Eligibility Criteria
Inclusion Criteria:
- Age more than 18 years
Exclusion Criteria:
- Contraindication to laparoscopy
- Liver disease
- Cognitive trouble
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pascal Bucher, MD, +41223723311, [email protected]
Location Countries
Switzerland
Location Countries
Switzerland
Administrative Informations
NCT ID
NCT00904865
Organization ID
CER-08-145
Study Sponsor
University Hospital, Geneva
Study Sponsor
Pascal Bucher, MD, Principal Investigator, University Hospital, Geneva
Verification Date
May 2009