Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy

Cholecystitis Clinical Trial

Official title:

Single Port Access Cholecystectomy Versus Standard Laparoscopic Cholecystectomy - Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00904865
• Other study ID #: CER-08-145
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: May 19, 2009
• Last updated: May 19, 2009
• Start date: February 2009

Study information

• Verified date: May 2009
• Source: University Hospital, Geneva
• Contact: Pascal Bucher, MD
• Phone: +41223723311
• Email: pascal.bucher[@]hcuge.ch
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age more than 18 years

Exclusion Criteria:

• Contraindication to laparoscopy

• Liver disease

• Cognitive trouble

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

Intervention

Procedure:
• SPA cholecystectomy
SPA cholecystectomy
• Laparoscopic cholecystectomy
Laparoscopic cholecystectomy

Locations

Country	Name	City	State
Switzerland	University Hospital Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Bucher P, Pugin F, Buchs N, Ostermann S, Charara F, Morel P. Single port access laparoscopic cholecystectomy (with video). World J Surg. 2009 May;33(5):1015-9. doi: 10.1007/s00268-008-9874-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cosmesis, body image and quality of life scale		at 1 month	No
Secondary	Post-operative morbidity		at 30 days	Yes
Secondary	Post-operative pain		10 days	No
Secondary	Operative time		day 1	No