Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy

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