Effects of prophylactic clip closure versus non-closure after colorectal endoscopic submucosal dissection on postoperative outcomes: A phase III prospective randomized controlled trial
Phase 3
- Conditions
- colorectal neoplasm
- Registration Number
- JPRN-UMIN000043675
- Lead Sponsor
- Asahi General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Preoperative endoscopic diagnosis of tumor depth is cT1b(SM2) (2) Lesions of local recurrence after endoscopic resection (3) Familial adenomatous polyposis and inflammatory bowel disease (4) Patients with thrombocytopenia and/or bleeding tendency (5) Women during pregnancy (6) Unsuitable patient for clinical trial judged by clinicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method delayed bleeding rate (severe) delayed bleeding rate (mild)
- Secondary Outcome Measures
Name Time Method delayed perforation rate Post-ESD coagulation syndrome rate clip closure time the number and type of clips for closure pathological findings procedure time resection speed en bloc resection rate complete resection rate curative resection rate the number of antithrombotic medicine users