Endoscopic hand-suturing (EHS) for mucosal defects after colorectal endoscopic submucosal dissection

UMIN ID: UMIN000047703

Registered date:15/05/2022

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: rectal cancer and sigmoid colon cancer
• Date of first enrollment: 2022/05/10
• Target sample size: 23
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Endoscopic hand suturing

Outcome(s)

• Primary Outcome: Suture retention on postoperative days 3-4. Suture time with a modified flexible needle holder.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients with a bleeding tendency (specifically if the following applies). *Platelet count less than 50,000/mm3 or PT-INR 2 or higher under non-compliance with anticoagulants. *Liver cirrhosis, Child-Pugh score B-C. *Chronic renal failure needs dialysis. 2) Patients who are unable to withdraw antithrombotic medications based on the guidelines. 3) Post-ESD mucosal defects overlying the anal verge. 4) History of abdominal or pelvic surgical resection. 5) History of radiation to the abdominal or pelvic region. 6) Patients whose attending physician determines that participation in this study is inappropriate.

Related Information

• Primary Sponsor: National Cancer Center Hospital
• Secondary Sponsor: Shizuoka Cancer Center
• Source(s) of Monetary Support: Japan Consortium for Advanced Surgical Endoscopy