Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy

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Cholecystitis
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Brief Title

Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy

Official Title

Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy: A Randomized Prospective Trial

Brief Summary

      This study will compare Single Incision Laparoscopic Surgery (SILS) cholecystectomy to
      traditional laparoscopic cholecystectomy (LC), focusing on patient-reported outcomes and
      cost.

Detailed Description

      Single-Incision Laparoscopic Surgery (SILS) is accepted as a form of surgical treatment.
      Traditional laparoscopic cholecystectomy (TLC) is well tolerated, with a low complication
      risk and high patient satisfaction; thus a SILS procedure needs to be at least equivalent to
      be a justifiable replacement, and should not result in higher costs.

Study Type

Interventional

Primary Outcome

Cost associated with performance of the procedure and post-operative care until discharge

Secondary Outcome

 Pain scale reported by patient at discharge, 24 and 48 hours

Condition

Biliary Dyskinesia

Intervention

Single-Incision Laparoscopic Surgery cholecystectomy

Study Arms / Comparison Groups

 Single-Incision Laparoscopic Cholecsytectomy (SILS)
Description:

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

87

Start Date

February 2010

Completion Date

January 2012

Primary Completion Date

January 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Patient recommended to undergo cholecystectomy

          -  Patient age 18-80

          -  Patient competent to give his/her own informed consent

          -  Patient speaks English without the need for an interpreter

        Exclusion Criteria:

          -  Additional procedures planned during same surgery

          -  Patient deemed inappropriate for TLC or SILS cholecystectomy

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Kimberly M Brown, BS, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01195285

Organization ID

09-423

Study Sponsor

Saint Luke's Health System

Collaborators

 Tyco Healthcare Group LP (d/b/a Covidien)

Study Sponsor

Kimberly M Brown, BS, MD, Principal Investigator, Saint Luke's Hospital of Kansas City

Verification Date

August 2011