JRCT ID: jRCT2072230089
Registered date:11/11/2023
Confirmatory trial with dMD-003
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Rectal cancer |
Date of first enrollment | 12/01/2024 |
Target sample size | 150 |
Countries of recruitment | |
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. |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | relations Public relations |
Address | 7, Yotsuya 1-chome, Shinjuku-ku, Tokyo Tokyo Japan 160-8515 |
Telephone | +81-332256303 |
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 |
dmd003.mdbd@mochida.co.jp | |
Affiliation | Mochida Pharmaceutical Co., Ltd. |