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Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by University Hospital, Geneva.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00904865
First Posted: May 20, 2009
Last Update Posted: May 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Geneva
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Port Access Cholecystectomy Versus Standard Laparoscopic Cholecystectomy - Randomized Study

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Post-operative morbidity [ Time Frame: at 30 days ]
  • Post-operative pain [ Time Frame: 10 days ]
  • Operative time [ Time Frame: day 1 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age more than 18 years

Exclusion Criteria:

  • Contraindication to laparoscopy
  • Liver disease
  • Cognitive trouble
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: May 19, 2009
First Posted: May 20, 2009
Last Update Posted: May 20, 2009
Last Verified: May 2009

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

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