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Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy

Children's Mercy Hospital Kansas City logo

Children's Mercy Hospital Kansas City

Status

Completed

Conditions

Biliary Dyskinesia
Cholelithiasis

Treatments

Procedure: Standard Laparoscopic Cholecystectomy
Procedure: SILS

Study type

Interventional

Funder types

Other

Identifiers

NCT00981604
09 07 132

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Need for cholecystectomy

Exclusion criteria

  • Need for cholangiogram

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

SILS Cholecystectomy
Active Comparator group
Description:
Single Incision Laparoscopic Cholecystectomy
Treatment:
Procedure: SILS
Standard Laparoscopic Cholecystectomy
Active Comparator group
Description:
4 port laparoscopic cholecystectomy
Treatment:
Procedure: Standard Laparoscopic Cholecystectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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