Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy
Recruitment status was: Recruiting
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.
Demonstrate the validity of Single port access (SPA) cholecystectomy compared to multiple ports laparoscopic cholecystectomy.
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.
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.
- Body image and Cosmetic results
- Post-operative pain (opioid sparing effect)
- Operative time
- Hospital stay
|Symptomatic Gallbladder Stones Cholecystitis Biliary Pancreatitis||Procedure: SPA cholecystectomy Procedure: Laparoscopic cholecystectomy||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Single Port Access Cholecystectomy Versus Standard Laparoscopic Cholecystectomy - Randomized Study|
- Cosmesis, body image and quality of life scale [ Time Frame: at 1 month ]
- Post-operative morbidity [ Time Frame: at 30 days ]
- Post-operative pain [ Time Frame: 10 days ]
- Operative time [ Time Frame: day 1 ]
|Study Start Date:||February 2009|
|Estimated Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Procedure: SPA cholecystectomy
Procedure: Laparoscopic cholecystectomy
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904865
|Contact: Pascal Bucher, MD||+41223723311 ext email@example.com|
|University Hospital Geneva||Recruiting|
|Geneva, Switzerland, 1211|
|Contact: Pascal Bucher, MD ¦41223723311 ext 7958420 firstname.lastname@example.org|
|Principal Investigator: Pascal Bucher, MD|
|Principal Investigator:||Pascal Bucher, MD||University Hospital, Geneva|