Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy (SILS)

December 12, 2011 updated by: Shawn St. Peter, Children's Mercy Hospital Kansas City

Single Incision Versus Laparoscopic Cholecystectomy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

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, 64108
        • Children's Mercy Hospital

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

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Need for cholecystectomy

Exclusion Criteria:

  • Need for cholangiogram

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: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Operative Time
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Operative complications
Time Frame: 2 weeks
2 weeks
length of hospitalization
Time Frame: 1 week
1 week
doses of analgesics
Time Frame: 1 week
1 week
hospital/operation charges
Time Frame: 1 week
1 week
surgeon perception of difficulty
Time Frame: 1 day
1 day
cosmetic scores
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Children's Mercy Hospital Kansas City

Investigators

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

August 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

September 21, 2009

First Submitted That Met QC Criteria

September 21, 2009

First Posted (Estimate)

September 22, 2009

Study Record Updates

Last Update Posted (Estimate)

December 13, 2011

Last Update Submitted That Met QC Criteria

December 12, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09 07 132

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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