Clincosm LogoSign in Get a demo

Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy

Sponsor
Children's Mercy Hospital Kansas City (Other)
Overall Status
Completed
CT.gov ID
NCT00981604
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
24
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.

Condition or Disease Intervention/Treatment Phase
  • Procedure: SILS
  • Procedure: Standard Laparoscopic Cholecystectomy
 N/A

Detailed Description

This will be a prospective, randomized clinical trial involving patients who present to the hospital with an indication for cholecystectomy. We will offer enrollment to several institutions provided they receive institutional approval.

This will be a definitive trial design. Based on our operative times with SILS compared with our recent experience in standard laparoscopy, a sample size of 60 patients will give us a power of 0.8 with an α of 0.05.

After the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Single Incision Versus Laparoscopic Cholecystectomy
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: SILS Cholecystectomy

Single Incision Laparoscopic Cholecystectomy

Procedure: SILS
Single Incision Laparoscopic Cholecystectomy
Active Comparator: Standard Laparoscopic Cholecystectomy

4 port laparoscopic cholecystectomy

Procedure: Standard Laparoscopic Cholecystectomy
4 port technique
Other Names:
  • Laparoscopic Cholecystectomy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Operative Time [1 day]

    Secondary Outcome Measures

    1. Operative complications [2 weeks]

    2. length of hospitalization [1 week]

    3. doses of analgesics [1 week]

    4. hospital/operation charges [1 week]

    5. surgeon perception of difficulty [1 day]

    6. cosmetic scores [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Need for cholecystectomy
    Exclusion Criteria:
    • Need for cholangiogram

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Mercy Hospital Kansas City Missouri United States 64108

    Sponsors and Collaborators

    • Children's Mercy Hospital Kansas City

    Investigators

    • Principal Investigator: Daniel J Ostlie, MD, Children's Mercy Hospital Kansas City

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shawn St. Peter, MD, Children's Mercy Hospital Kansas City
    ClinicalTrials.gov Identifier:
    NCT00981604
    Other Study ID Numbers:
    • 09 07 132
    First Posted:
    Sep 22, 2009
    Last Update Posted:
    Dec 13, 2011
    Last Verified:
    Dec 1, 2011
    Keywords provided by Shawn St. Peter, MD, Children's Mercy Hospital Kansas City
    SILS
    Laparoscopic Cholecystectomy
    Children
    Additional relevant MeSH terms:
    Cholelithiasis
    Cholecystolithiasis
    Gallstones
    Biliary Dyskinesia
    Dyskinesias

    Study Results

    No Results Posted as of Dec 13, 2011