Clinical Evaluation of Spring-Type Laparoscopic Clip Technology
| Status: | Terminated |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/8/2017 |
| Start Date: | July 2007 |
| End Date: | September 2008 |
The Visu-Loc spring clip is being used to occlude the cystic duct at the time of laparoscopic
cholecystectomy. A hepato-iminodiacetic acid (HIDA) scan will be completed on post operative
day one to check for biliary leaks.
cholecystectomy. A hepato-iminodiacetic acid (HIDA) scan will be completed on post operative
day one to check for biliary leaks.
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.
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.
Inclusion Criteria:
- Adult(18 or older)
- Diagnosis of cholelithiasis or cholecystitis
- Diagnosis of choledocholithiasis or biliary dyskinesia
- scheduled fo laparoscopic cholecystectomy
- Females: NOT pregnant
Exclusion Criteria:
- Breastfeeding
- Malignancy
- Inflammatory bowel disease (IBD)
- Ulcerative colitis (UC)
- Receiving steroids
- Severe chronic obstructive pulmonary disease (COPD) or pulmonary disorder
- History of connective tissue disorder
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