Validation study of watchful waiting for bleeding after colorectal endoscopic submucosal dissection

JRCT ID: jRCT1052230022

Registered date:17/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Colorectal neoplasm
• Date of first enrollment: 15/05/2023
• Target sample size: 480
• Study type: Interventional
• Intervention(s): Determination whether emergency endoscopy is indicated based on the "treatment policy for hematochezia after colorectal ESD"

Outcome(s)

Primary Outcome

1. Receiving blood transfusion
2. Receiving colonoscopy within 48 hours after the end of ESD

Secondary Outcome

1. Receiving hemostasis
2. Hospitalization days
3. Hb value
4. Presence or absence of complications other than bleeding
5. Presence or absence of hematochezia and receiving colonoscopy from 48 hours to 28 days after colorectal ESD

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Takehara Tetsuo