Clinical Evaluation of Spring-Type Laparoscopic Clip Technology
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Clinical Evaluation of Spring-Type Laparoscopic Clip Technology|
- No leak, subclinical leak or clinical bile leak on post-operative HIDA scan. [ Time Frame: By post op day one HIDA scan. ] [ Designated as safety issue: Yes ]
- Any other evidence of biliary leak. Surgeon assessments of device use: ease of use , deployment and clip security. [ Time Frame: By post op day one HIDA scan. ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.
Device: 5mm spring clip
Microline Pentax 5mm Visu-Loc Clip Applier
The purpose of this study is to evaluate how effective the Visu-Lock clip is at preventing leakage of bile (liquid made by liver and stored in gall bladder) after gallbladder surgery. It is not known if the Visu-Lock clip stops leaks better than other clips that have been used during gallbladder surgery.
Null hypothesis: There is no difference in subclinical or clinical leak rate between spring and crush clips used for cystic duct ligation.
Alternative hypothesis: Titanium spring clips decrease the rate of subclinical or clinical biliary leak from the cystic duct stump after laparoscopic cholecystectomy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00527644
|United States, Missouri|
|University of Missouri Hospital and Clinics|
|Columbia, Missouri, United States, 65212|
|Principal Investigator:||Bruce Ramshaw, MD||Chief, Division of General Surgery|