NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000047703

Registered date:15/05/2022

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

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedrectal cancer and sigmoid colon cancer
Date of first enrollment2022/05/10
Target sample size23
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Endoscopic hand suturing

Outcome(s)

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

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) 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

Contact

public contact
Name Takeshi Uozumi
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan Japan 104-0045
Telephone 0335422511
E-mail tuozumi@ncc.go.jp
Affiliation National Cancer Center Hospital Endoscopy Division
scientific contact
Name Yutaka Saito
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan Japan
Telephone 0335422511
E-mail ytsaito@ncc.go.jp
Affiliation National Cancer Center Hospital Endoscopy Division