JPRN-UMIN000018727
Completed
N/A
Prospective multi-center registry about clinical performance for the abdominal surgery using the absorbable adhesion barrier (INTERCEED) made of oxidized regenerated cellulose. - Prospective multi-center registry about clinical performance for the abdominal surgery using the absorbable adhesion barrier (INTERCEED) made of oxidized regenerated cellulose.
Johnson&Johnson K.K. Medical Company0 sites200 target enrollmentAugust 23, 2015
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Abdominal laparoscopic surgery for colon and rectum
- Sponsor
- Johnson&Johnson K.K. Medical Company
- Enrollment
- 200
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\. Subjects in whom the laparoscopic procedure needs to be converted to open surgery. 2\. Patients in whom significant adhesive disease is already present at the inception of the procedure requiring adhesiolysis that impacts surgical time. 3\. Subjects in whom a complete excision of the tumor could not be achieved. 4\. Subjects with intraoperative intraperitoneal administration of chemotherapy. 5\. Subjects with severe hepatic dysfunction, renal failure, heart disease and infectious disease. 6\. Subjects in whom alternate adhesive prevention methods are used 7\. Subjects in whom complete hemostasis could not be achieved at the location where INTERCEED was going to be used 8\. Subjects in whom the location where INTERCEED was going to be used is considered infected 9\. Subjects with history of severe drug allergy. 10\. Subjects with allergy of oxidized regenerated cellulose. 11\. Subjects in whom the treating physician does not feel that the application of INTERCEED is appropriate
Outcomes
Primary Outcomes
Not specified
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