An interventional study of SILS and Standard Laparoscopic Cholecystectomy in Cholelithiasis and Biliary Dyskinesia, sponsored by Children's Mercy Hospital Kansas City. Completed at 1 site in United States. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2011-12-13.
Sponsored by Children's Mercy Hospital Kansas City · Not applicable, Interventional, and Treatment
Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.
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.
286 studies on the registry are indexed under Cholelithiasis; 48 are open to participants now.
This study's planned enrollment of 60 is below the median of 90 across 197 interventional studies indexed under Cholelithiasis.
Browse Cholelithiasis studies →Children's Mercy Hospital Kansas City is the lead sponsor of 209 studies on the registry; 22 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single Incision Laparoscopic Cholecystectomy
Procedure: SILS
4 port laparoscopic cholecystectomy
Procedure: Standard Laparoscopic Cholecystectomy
Single Incision Laparoscopic Cholecystectomy
4 port technique
Also known as: Laparoscopic Cholecystectomy
Operative Time
Time frame: 1 day
Operative complications
Time frame: 2 weeks
length of hospitalization
Time frame: 1 week
doses of analgesics
Time frame: 1 week
hospital/operation charges
Time frame: 1 week
surgeon perception of difficulty
Time frame: 1 day
cosmetic scores
Time frame: 6 months
This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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Children's Mercy Hospital Kansas City