JPRN-jRCT1092220091
Completed
未知
Clinical trial to evaluate the efficacy and safety of nDM-14R intended for two-stage operation cases.
Kawasumi. laboratory .inc0 sites130 target enrollmentJuly 2, 2012
ConditionsPostoperative Adhesion
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Postoperative Adhesion
- Sponsor
- Kawasumi. laboratory .inc
- Enrollment
- 130
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Patients of 20 years or more at the time of obtaining informed consent.
- •(2\) Patient who will have covering colostomy and colostomy closure.
- •(3\) Patient or legal representative who well understand the protocol with written informed consent.
Exclusion Criteria
- •(1\) Patient scheduled for first\-stage laparoscopic surgery.
- •(2\) Patient who need intraperitoneal injection of perfusate of drugs that affect on adhesion formation during 24 hours to 7 days after first\-stage surgery.
- •(3\) Patient who have had previous abdominal median incision.
- •(4\) Cancer patient of stageIV.
- •(5\) Patient with ECOG Performance Status over 3\.
- •(6\) Patient with a history of severe drug allergy.
- •(7\) Patient with an allergy to materials of investigational device.
- •(8\) Patient with body\-wide infection.
- •(9\) Patient who wish to become pregnant during the study or pregnant, lactating.
- •(10\) Patient from the course of the disease, life expectancy less than one year.
Outcomes
Primary Outcomes
Not specified
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