Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy

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Brief Title

Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy

Official Title

Single Port Access Cholecystectomy Versus Standard Laparoscopic Cholecystectomy - Randomized Study

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
    


Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Cosmesis, body image and quality of life scale

Secondary Outcome

 Post-operative morbidity

Condition

Symptomatic Gallbladder Stones

Intervention

SPA cholecystectomy

Study Arms / Comparison Groups

 1
Description:  SPA cholecystectomy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

200

Start Date

February 2009


Primary Completion Date

February 2011

Eligibility Criteria

        Inclusion Criteria:

          -  Age more than 18 years

        Exclusion Criteria:

          -  Contraindication to laparoscopy

          -  Liver disease

          -  Cognitive trouble
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pascal Bucher, MD, +41223723311, [email protected]

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT00904865

Organization ID

CER-08-145



Study Sponsor

University Hospital, Geneva


Study Sponsor

Pascal Bucher, MD, Principal Investigator, University Hospital, Geneva


Verification Date

May 2009