Validation study of watchful waiting for bleeding after colorectal endoscopic submucosal dissectio
Phase 2
Recruiting
- Conditions
- Colorectal neoplasmColorectal Neoplasms, Endoscopic Submucosal Dissections, Hematochezia
- Registration Number
- JPRN-jRCT1052230022
- Lead Sponsor
- Takehara Tetsuo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 480
Inclusion Criteria
1. Patients who plan to receive endoscopic submucosal dissection (ESD) for colorectal tumors.
2. Age at the time of registration is 18 years or older.
3. Performance status is 0-1 according to ECOG standards.
4. Written consent has been obtained from the patient to participate in the research.
Exclusion Criteria
1. Having a colorectal disease that can cause hematochezia, e.g. advanced colorectal cancer, inflammatory bowel disease.
2. Anemia with Hb value less than 10g/dl.
3. Having serious diseases, e.g. liver cirrhosis, renal failure.
4. Taking antithrombotic drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Receiving blood transfusion<br>2. Receiving colonoscopy within 48 hours after the end of ESD
- Secondary Outcome Measures
Name Time Method 1. Receiving hemostasis<br>2. Hospitalization days<br>3. Hb value<br>4. Presence or absence of complications other than bleeding<br>5. Presence or absence of hematochezia and receiving colonoscopy from 48 hours to 28 days after colorectal ESD