Clinical trial NCT00904865: Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy
Official title: Single Port Access Cholecystectomy Versus Standard Laparoscopic Cholecystectomy - Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Symptomatic Gallbladder Stones
Cholecystitis
Biliary Pancreatitis
Keywords: Single port access
Laparoscopy
cholecystectomy
cholangiography
cosmesis
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2009-05-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Age more than 18 years

Exclusion Criteria:

* Contraindication to laparoscopy
* Liver disease
* Cognitive trouble

Primary outcomes:
measure: Cosmesis, body image and quality of life scale
timeFrame: at 1 month
Secondary outcomes:
measure: Post-operative morbidity
timeFrame: at 30 days
measure: Post-operative pain
timeFrame: 10 days
measure: Operative time
timeFrame: day 1
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital Geneva
Study officials:
affiliation: University Hospital, Geneva
name: Pascal Bucher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bucher P, Pugin F, Buchs NC, Ostermann S, Morel P. Randomized clinical trial of laparoendoscopic single-site versus conventional laparoscopic cholecystectomy. Br J Surg. 2011 Dec;98(12):1695-702. doi: 10.1002/bjs.7689. Epub 2011 Sep 30.
citation: Steinemann DC, Raptis DA, Lurje G, Oberkofler CE, Wyss R, Zehnder A, Lesurtel M, Vonlanthen R, Clavien PA, Breitenstein S. Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial). BMC Surg. 2011 Sep 12;11:24. doi: 10.1186/1471-2482-11-24.