Status:
TERMINATED
Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses
Lead Sponsor:
W.L.Gore & Associates
Conditions:
Rectal Cancer
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable st...
Detailed Description
This is a randomized prospective trial that compares the use of GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement (CBSG) to standard stapling techniques in colorectal resections. The potential e...
Eligibility Criteria
Inclusion
- Subjects who will undergo restorative proctectomy or proctocolectomy (\<10 cm from anal verge) with a low circular stapled colorectal, coloanal or ileoanal anastomosis with or without reservoir, including treatment for rectal cancer, ulcerative colitis, familial adenomatous polyposis
- , diverticulitis, perforation of the bowel/trauma.
- Subjects undergoing Hartmann's reversal with restorative proctectomy (\<10 cm from the anal verge).
- Subjects may or may not have a diverting loop ileostomy as a component of their initial surgery.
- Subjects who meet the requirements of number 1 and 2, and are being treated for rectal cancer may or may not have preoperative chemoradiation therapy in the treatment of their rectal cancer.
Exclusion
- Subjects being treated for rectal cancer with a diagnosis of inflammatory bowel disease.
- Subjects who have significant intraoperative hypotension or cardiac events.
- Subjects with collagen vascular disease, coagulopathy, significant renal or hepatic dysfunction (creatinine \>1.6 or liver enzymes \> 50% upper limit of normal values).
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT00663819
Start Date
April 1 2008
End Date
October 1 2012
Last Update
April 17 2018
Active Locations (16)
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1
University of South Alabama
Mobile, Alabama, United States, 36617
2
University of Southern California, Keck School of Medicine
Los Angeles, California, United States, 90033
3
University of South Florida-Cleveland Clinic Florida
Weston, Florida, United States, 33331
4
Advocate Healthcare/Good Shepard Hospital
Barrington, Illinois, United States, 60010