Prospective Observational Study on the Efficacy and Safety of Endoscopic Suturing Using Mantis for Mucosal Defects After Colorectal Endoscopic Submucosal Dissection (ESD)

JRCT ID: jRCT1072230133

Registered date:28/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Colorectal neoplasm
• Date of first enrollment: 28/03/2024
• Target sample size: 50
• Study type: Observational

Outcome(s)

• Primary Outcome: Complete suture rate of the wound

Secondary Outcome

(1) Number of suturing clips used (Mantis/Long/Normal/Short)
(2) Suturing time
(3) Rate of submucosal dead space (SDS) formation
(4) ESD duration
(5) En bloc resection
(6) Complete en bloc resection
(7) Curative resection
(8) Operator change during wound suturing

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients diagnosed with colorectal epithelial tumors of 20-50mm through endoscopic examination, undergoing ESD.
(2) Preoperative diagnosis is adenoma or early cancer (cT1a).
(3) Patients who are 20 years of age or older at the time of consent acquisition.
(4) Patients with a Performance Status of 0, 1, or 2.
(5) Patients who have received sufficient explanation about this research plan, fully understand it, and are capable of giving consent on their own.

Exclude criteria

(1) Cecal lesions involving the ileocecal valve or the opening of the appendix.
(2) Colonic lesions involving a diverticulum.
(3) Rectal lesions involving the lower rectum.
(4) Patients undergoing dialysis.
(5) Patients requiring continuous administration of heparin during the perioperative period.
(6) Patients for whom endoscopic examination is contraindicated (patients with ileus, gastrointestinal perforation, severe respiratory diseases, and cardiovascular diseases).
(7) Patients deemed inappropriate for the study by the attending physician.

Related Information

• Primary Sponsor: Sumida Yorinobu