Prospective multi-center registry about clinical performance for the abdominal surgery using the absorbable adhesion barrier (INTERCEED) made of oxidized regenerated cellulose.
- Conditions
- Abdominal laparoscopic surgery for colon and rectum
- Registration Number
- JPRN-UMIN000018727
- Lead Sponsor
- Johnson&Johnson K.K. Medical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adhesive Intestinal Obstruction
- Secondary Outcome Measures
Name Time Method - Revision surgery -- Revision surgery related to postoperative bleeding -- Revision surgery related to anastomotic leak/ drainage - Surgical Site Infection (SSI) -- Superficial incisional surgical site infection -- Deep incisional surgical site infection -- Organ surgical site infection - Anastomotic leak - Other adverse events that lead to therapeutic interventions (surgery and/ or medication that differ from the standard pathway of care) - Death