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JAPANESE
国立保健医療科学院
JRCT ID: jRCT2072230089

Registered date:11/11/2023

Confirmatory trial with dMD-003

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedRectal cancer
Date of first enrollment12/01/2024
Target sample size150
Countries of recruitment
Study typeInterventional
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 OutcomePresence or absence of adhesion.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
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

Contact

Public contact
Name relations Public relations
Address 7, Yotsuya 1-chome, Shinjuku-ku, Tokyo Tokyo Japan 160-8515
Telephone +81-332256303
E-mail webmaster@mochida.co.jp
Affiliation Mochida Pharmaceutical Co., Ltd.
Scientific contact
Name Fumiaki Aihara
Address 7, Yotsuya 1-chome, Shinjuku-ku, Tokyo Tokyo Japan 160-8515
Telephone +81-3-3225-6306
E-mail dmd003.mdbd@mochida.co.jp
Affiliation Mochida Pharmaceutical Co., Ltd.