Confirmatory trial with dMD-003

JRCT ID: jRCT2072230089

Registered date:11/11/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Rectal cancer
• Date of first enrollment: 01/11/2023
• Target sample size: 150
• Study type: Interventional
• Intervention(s): The study device (dMD-003 or Seprafilm) is applied, in principle, under the midline incision immediately before wound closure in a temporary ileostomy.

Outcome(s)

• Primary Outcome: Presence or absence of adhesion.

Key inclusion & exclusion criteria

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

Include criteria

(1) Patients with initial and primary rectal cancer.
(2) Patients with cStage 0 to cStage III cancer.
(3) Patients who are scheduled to undergo laparoscopic or robot-assisted rectal resection in which a temporary ileostomy is scheduled to be performed.
Other criteria.

Exclude criteria

(1) Patients who have previously undergone surgery in the abdominal cavity (excluding appendicitis surgery).
(2) Patients with cStage IV cancer.
(3) Patients who are scheduled to have samples removed from a site other than the midline incision.
Other criteria.

Related Information

• Primary Sponsor: Aihara Fumiaki