Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal, Coloanal and Ileoanal Anastomoses: A Prospective Randomized Study
18 Years
N/A
Both
Ileostomy, When Applicable, Rectal Cancer, When Applicable, Ulcerative Colitis, FAP, Diverticulitis, Hartmann's Reversal
Trial Information
Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal, Coloanal and Ileoanal Anastomoses: A Prospective Randomized Study
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 exists to utilize CBSG as a means of lowering the rate of
post-operative anastomotic leakage and bleeding in high-risk colorectal, coloanal, and
ileoanal anastomoses.
Inclusion Criteria:
- 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,
FAP, 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 Criteria:
- 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).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the clinical and radiologic postoperative anastomotic leak rate in high-risk circular stapled colorectal, coloanal,and ileoanal anastomoses using CBSG.
Outcome Time Frame:
completion of procedure and follow-up visits
Safety Issue:
No
Principal Investigator
Anthony J Senagore, MD, MBA, MS
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Southern California, Keck School of Medicine
Authority:
United States: Institutional Review Board
Study ID:
2008-109
NCT ID:
NCT00663819
Start Date:
April 2008
Completion Date:
October 2012
Related Keywords:
- Ileostomy, When Applicable
- Rectal Cancer, When Applicable
- Ulcerative Colitis, FAP, Diverticulitis, Hartmann's Reversal
- Low anterior colon resection
- Proctectomy
- Proctocolectomy
- Anastomosis
- Rectal Cancer
- Ileostomy
- Rectal Neoplasms
- Colitis
- Colitis, Ulcerative
- Diverticulitis
- Ulcer
Name | Location |
|---|---|
| Duluth Clinic | Duluth, Minnesota 55805 |
| New York Presbyterian Hospital | New York, New York 10021 |
| University of South Alabama | Mobile, Alabama 36693 |
| University of Southern California, Keck School of Medicine | Los Angeles, California 90033 |
| Albany Medical College | Albany, New York |
| University of South Florida-Cleveland Clinic Florida | Weston, Florida 33331 |
| Advocate Healthcare/Good Shepard Hospital | Barrington, Illinois 60010 |
| John Stroger Hospital of Cook County | Chicago, Illinois 60612 |
| Peoria Surgical Group | Peoria, Illinois 61606 |
| Colon and Rectal Surgery-NEICRS Group | Fort Wayne, Indiana 46845 |
| Kenderick Regional Center | Indianapolis, Indiana 46237 |
| Spectrum Health -Ferguson Group | Grand Rapids, Michigan 49503 |
| St. Lukes-Roosevelt Hospital Center | New York, New York 10019 |
| University Hospitals of Cleveland, Case Medical Center | Cleveland, Ohio 44106-5047 |
| Texas Endosurgery Institute | San Antonio, Texas 78222 |
| University of Utah Health Sciences Center and Huntsman Cancer Hospital | Salt Lake City, Utah 84132 |
