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Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University Hospital, Geneva.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00904865
First received: May 19, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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

Condition Intervention Phase
Symptomatic Gallbladder Stones
Cholecystitis
Biliary Pancreatitis
 Procedure: SPA cholecystectomy
Procedure: Laparoscopic cholecystectomy
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Port Access Cholecystectomy Versus Standard Laparoscopic Cholecystectomy - Randomized Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Cosmesis, body image and quality of life scale [ Time Frame: at 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-operative morbidity [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
  • Post-operative pain [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Operative time [ Time Frame: day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2009
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
SPA cholecystectomy
 Procedure: SPA cholecystectomy
SPA cholecystectomy
2
laparoscopic cholecystectomy
 Procedure: Laparoscopic cholecystectomy
Laparoscopic cholecystectomy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age more than 18 years

Exclusion Criteria:

  • Contraindication to laparoscopy
  • Liver disease
  • Cognitive trouble
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904865

Contacts
Contact: Pascal Bucher, MD +41223723311 ext 7958420 pascal.bucher@hcuge.ch

Locations
Switzerland
University Hospital Geneva Recruiting
Geneva, Switzerland, 1211
Contact: Pascal Bucher, MD     ¦41223723311 ext 7958420     pascal.bucher@hcuge.ch    
Principal Investigator: Pascal Bucher, MD            
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Pascal Bucher, MD University Hospital, Geneva
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bucher Pascal, MD, University Hospital Geneva
ClinicalTrials.gov Identifier: NCT00904865     History of Changes
Other Study ID Numbers: CER-08-145
Study First Received: May 19, 2009
Last Updated: May 19, 2009
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:
Single port access
Laparoscopy
cholecystectomy
cholangiography
cosmesis

Additional relevant MeSH terms:
Cholecystitis
Acalculous Cholecystitis
Cholelithiasis
Cholecystolithiasis
Gallstones
Pancreatitis
 Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Calculi
Pathological Conditions, Anatomical
Pancreatic Diseases

ClinicalTrials.gov processed this record on June 17, 2013