Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy
This study has been completed.
Sponsor:
Children's Mercy Hospital Kansas City
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00981604
First received: September 21, 2009
Last updated: December 12, 2011
Last verified: December 2011
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Purpose
Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.
| Condition | Intervention |
|---|---|
|
Cholelithiasis Biliary Dyskinesia |
Procedure: SILS Procedure: Standard Laparoscopic Cholecystectomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Single Incision Versus Laparoscopic Cholecystectomy |
Resource links provided by NLM:
Further study details as provided by Children's Mercy Hospital Kansas City:
Primary Outcome Measures:
- Operative Time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Operative complications [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
- length of hospitalization [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- doses of analgesics [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- hospital/operation charges [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- surgeon perception of difficulty [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- cosmetic scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2009 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: SILS Cholecystectomy
Single Incision Laparoscopic Cholecystectomy
|
Procedure: SILS
Single Incision Laparoscopic Cholecystectomy
Other Name: SILS
|
|
Active Comparator: Standard Laparoscopic Cholecystectomy
4 port laparoscopic cholecystectomy
|
Procedure: Standard Laparoscopic Cholecystectomy
4 port technique
Other Name: Laparoscopic Cholecystectomy
|
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.
Eligibility| Ages Eligible for Study: | 1 Year to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Need for cholecystectomy
Exclusion Criteria:
- Need for cholangiogram
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981604
Locations
| United States, Missouri | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
| Principal Investigator: | Daniel J Ostlie, MD | Children's Mercy Hospital Kansas City |
More Information
No publications provided
| Responsible Party: | Shawn St. Peter, MD, Children's Mercy Hospital Kansas City |
| ClinicalTrials.gov Identifier: | NCT00981604 History of Changes |
| Other Study ID Numbers: | 09 07 132 |
| Study First Received: | September 21, 2009 |
| Last Updated: | December 12, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Mercy Hospital Kansas City:
|
SILS Laparoscopic Cholecystectomy Children |
Additional relevant MeSH terms:
|
Biliary Dyskinesia Cholelithiasis Cholecystolithiasis Gallstones Dyskinesias Common Bile Duct Diseases Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases |
Gallbladder Diseases Calculi Pathological Conditions, Anatomical Movement Disorders Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013