Infection Clinical Trial
Official title:
Randomised Controlled Trial of Fibrin Sealant to Prevent Bile Leakage After Cholangiotomy
Bile leak reduction from the common bile duct, as a result of glue appliance after cholangiotomy.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Gallbladder disease Exclusion Criteria: - Cancer/Tumor |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Lasarettet i Enkoping | Enkoping | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Lasarettet i Enköping |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative biliary leakage | The amount of bile in the drain is measured daily until it is withdrawn | From the the day of surgery until discharge and/or removal of abdominal drain, up to two weeks | Yes |
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