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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00981604
Other study ID # 09 07 132
Secondary ID
Status Completed
Phase N/A
First received September 21, 2009
Last updated December 12, 2011
Start date August 2009
Est. completion date August 2011

Study information

Verified date December 2011
Source Children's Mercy Hospital Kansas City
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 18 Years
Eligibility Inclusion Criteria:

- Need for cholecystectomy

Exclusion Criteria:

- Need for cholangiogram

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
SILS
Single Incision Laparoscopic Cholecystectomy
Standard Laparoscopic Cholecystectomy
4 port technique

Locations

Country Name City State
United States Children's Mercy Hospital Kansas City Missouri

Sponsors (1)

Lead Sponsor Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Operative Time 1 day No
Secondary Operative complications 2 weeks Yes
Secondary length of hospitalization 1 week No
Secondary doses of analgesics 1 week No
Secondary hospital/operation charges 1 week No
Secondary surgeon perception of difficulty 1 day No
Secondary cosmetic scores 6 months No
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