Biliary Dyskinesia, Cholelithiasis
Conditions
Keywords
SILS, Laparoscopic Cholecystectomy, Children
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.
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.
Interventions
PROCEDURESILS
Single Incision Laparoscopic Cholecystectomy
4 port technique
Sponsors
Children's Mercy Hospital Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Need for cholecystectomy
Exclusion criteria
* Need for cholangiogram
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Operative Time | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| length of hospitalization | 1 week |
| doses of analgesics | 1 week |
| Operative complications | 2 weeks |
| surgeon perception of difficulty | 1 day |
| cosmetic scores | 6 months |
| hospital/operation charges | 1 week |
Countries
United States
Outcome results
None listed