Clinical trial to evaluate the efficacy and safety of nDM-14R intended for two-stage operation cases.
- Conditions
- Postoperative Adhesion
- Registration Number
- JPRN-jRCT1092220091
- Lead Sponsor
- Kawasumi. laboratory .inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
(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.
(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.
(11) Participation in other clinical studies either concurrently or within the last three months.
(12) Patient who were deemed inappropriate as the subject of clinical trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The presence or absence of post operation adhesion
- Secondary Outcome Measures
Name Time Method Adhesion area / adhesion grade