Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy
NCT ID: NCT00981604
Last Updated: 2011-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2009-08-31
2011-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SILS Cholecystectomy
Single Incision Laparoscopic Cholecystectomy
SILS
Single Incision Laparoscopic Cholecystectomy
Standard Laparoscopic Cholecystectomy
4 port laparoscopic cholecystectomy
Standard Laparoscopic Cholecystectomy
4 port technique
Interventions
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SILS
Single Incision Laparoscopic Cholecystectomy
Standard Laparoscopic Cholecystectomy
4 port technique
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Year
18 Years
ALL
No
Sponsors
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Children's Mercy Hospital Kansas City
OTHER
Responsible Party
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Shawn St. Peter
MD
Principal Investigators
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Daniel J Ostlie, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Mercy Hospital Kansas City
Locations
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Children's Mercy Hospital
Kansas City, Missouri, United States
Countries
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References
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Ostlie DJ, Juang OO, Iqbal CW, Sharp SW, Snyder CL, Andrews WS, Sharp RJ, Holcomb GW 3rd, St Peter SD. Single incision versus standard 4-port laparoscopic cholecystectomy: a prospective randomized trial. J Pediatr Surg. 2013 Jan;48(1):209-14. doi: 10.1016/j.jpedsurg.2012.10.039.
Other Identifiers
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09 07 132
Identifier Type: -
Identifier Source: org_study_id