An Evaluation of the SprayShield Adhesion Barrier System in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Ulcerative Colitis, Familial Polyposis
Both
Ulcerative Colitis, Familial Polyposis
Trial Information
An Evaluation of the SprayShield Adhesion Barrier System in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery
Inclusion Criteria:
- Diagnosis of ulcerative colitis or familial polyposis and require two-stage surgery
for treatment of either of these disorders will be eligible
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Outcome Measure:
To evaluate the incidence of adhesions, defined as the proportion of subjects presenting at the follow-up surgery (10-12 weeks) with one or more adhesions to the midline incision, regardless of extent and/or severity.
Outcome Time Frame:
10-12 Weeks post Initial Surgery for J-Pouch
Safety Issue:
No
Authority:
Czech Republic: Ethics Committee
Study ID:
ABD-08-001
NCT ID:
NCT01002287
Start Date:
October 2009
Completion Date:
May 2011
Related Keywords:
- Ulcerative Colitis
- Familial Polyposis
- Colitis
- Colitis, Ulcerative
- Adenomatous Polyposis Coli
- Ulcer
Name | Location |
|---|---|
| Confluent Surgical | Waltham, Massachusetts 02451 |
