Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy

April 27, 2012 updated by: Saint Luke's Health System

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke'S Hospital of Kansas City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Single-Incision Laparoscopic Cholecsytectomy (SILS)
Procedure: Single-Incision Laparoscopic Surgery cholecystectomy
Laparoscopic Cholecystectomy
Active Comparator: Traditional Laparoscopic Cholecystectomy (TLC)
Procedure: Traditional Laparoscopic Cholecystectomy (TLC)
Laparoscopic Cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cost associated with performance of the procedure and post-operative care until discharge
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain scale reported by patient at discharge, 24 and 48 hours
Time Frame: 24 hours and 48 hours
24 hours and 48 hours
Amount of pain medicine required during 48 hours after surgery
Time Frame: 48 hours
48 hours
Major and minor gastrointestinal surgical complications, including conversion
Time Frame: 4 weeks
4 weeks
Quality of Life
Time Frame: 2 weeks and 4 weeks
2 weeks and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Luke's Health System

Collaborators

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

Investigators

  • Principal Investigator: Kimberly M Brown, BS, MD, Saint Luke'S Hospital of Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

September 2, 2010

First Submitted That Met QC Criteria

September 3, 2010

First Posted (Estimate)

September 6, 2010

Study Record Updates

Last Update Posted (Estimate)

April 30, 2012

Last Update Submitted That Met QC Criteria

April 27, 2012

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-423

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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