The safety of liver surgery with No-Drain policy: a multicenter randomized controlled trial
Phase 2
- Conditions
- Elective hepatic resection without biliary reconstruction
- Registration Number
- JPRN-UMIN000017608
- Lead Sponsor
- Hepatobiliary-Pancreatic Surgery Division, Graduate School of Medicine, University of Tokyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Not provided
Exclusion Criteria
1) Concomitant resection of other organs excluding gallbladder 2) Administration of anti-coagulant drug just before the operation 3) Schedule to administrate anti-coagulant drug by 3 days after operation 4) Psychiatric disorder 5) Pregnant 6) Supposed extremely high risk of biliary leakage or bleeding after operation because of area of hepatic transection, and exposure of Glisson sheath on transection surface 7) C-tube placement 8) Thoracic tube placement
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of postoperative complication at or greater than Clavien-Dindo grade 3
- Secondary Outcome Measures
Name Time Method Wound-related complication, total postoperative complication, biliary leakage, inflammatory indicator in blood and serum examination, duration of postoperative hospital stay