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Sponsors and Collaborators: |
Spectrum Health Hospitals W.L.Gore & Associates |
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Information provided by: | Spectrum Health Hospitals |
ClinicalTrials.gov Identifier: | NCT00663819 |
The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal and coloanal anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced colorectal and coloanal techniques with respect to the incidence of postoperative anastomotic leakage, anastomotic stricture and time to ileostomy closure.
Condition | Intervention |
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Ileostomy Colorectal Surgery Proctectomy Anastomosis Rectal Cancer |
Device: GORE SEAMGUARD® |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal and Coloanal Anastomoses: A Prospective Randomized Study |
Estimated Enrollment: | 750 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
GORE Bioabsorbable Seamguard* Staple Line Reinforcement material used to reinforce anastomotic staple lines
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Device: GORE SEAMGUARD®
The rates of anastomotic leaks will be compared using standard stapling anastomosis versus the GORE SEAMGUARD® anastomoses.
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2: Active Comparator
Standard non-reinforced anastomotic staple lines
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Device: GORE SEAMGUARD®
The rates of anastomotic leaks will be compared using standard stapling anastomosis versus the GORE SEAMGUARD® anastomoses.
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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 and coloanal anastomoses.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Linda Lamphere | 928-864-3439 | llampher@wlgore.com |
Contact: Jason Smith | 610-675-6135 | jsmith@wlgore.com |
United States, Florida | |
University of South Florida-Cleveland Clinic Florida | Not yet recruiting |
Weston, Florida, United States, 33331 | |
Contact: Juanita Woodard 954-659-6020 woodarj@ccf.org | |
Principal Investigator: Steven D. Wexner, MD, FACS, FRCS, FRCS(ED) | |
Sub-Investigator: Eric Weiss, MD | |
Sub-Investigator: Juan Nogueras, MD | |
Sub-Investigator: Christina Seo, MD | |
Sub-Investigator: Dana Sands, MD | |
United States, Illinois | |
Advocate Healthcare/Good Shepard Hospital | Not yet recruiting |
Barrington, Illinois, United States, 60010 | |
Contact: Nancy Fisco, RN 847-381-8167 David.Ondrula-MD@advocatehealth.com | |
Principal Investigator: David P Ondrula, MD | |
University of Illinois Surgery | Not yet recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Sandi Tenfelde, PhD(c), APN 312-413-2708 stenfeld@uic.edu | |
Principal Investigator: Marc Singer, MD | |
Sub-Investigator: Herand Abcarian, MD | |
Sub-Investigator: Jose Contron, MD | |
Peoria Surgical Group | Recruiting |
Peoria, Illinois, United States, 61603 | |
Contact: Danuta Dynda, MD dynda_di@yahoo.com | |
Principal Investigator: Julius Bonello, MD | |
United States, Indiana | |
Kenderick Regional Center | Recruiting |
Indianapolis, Indiana, United States, 46237 | |
Contact: Frederick R. Lane, MD 317-889-7906 FredL422@aol.com | |
Principal Investigator: Frederick R. Lane, MD | |
Sub-Investigator: Bridget Sanders, MD | |
Sub-Investigator: R. Barry Melbert, MD | |
Sub-Investigator: Olaf Johansen, MD | |
Sub-Investigator: Dipen Maun, MD | |
Colon and Rectal Surgery-NEICRS Group | Not yet recruiting |
Fort Wayne, Indiana, United States, 46845 | |
Contact: Paul Raiman, MD 800-801-9102 prperewin@comcast.net | |
Principal Investigator: Paul Raiman, MD | |
Sub-Investigator: Paul Conarty, MR | |
Sub-Investigator: James Edlund, MD | |
Sub-Investigator: Hisham Elhassan, MD | |
Sub-Investigator: Ateet Shah, MD | |
United States, Michigan | |
Spectrum Health | Recruiting |
Grand Rapids, Michigan, United States, 49503 | |
Contact: Alison J Dutkiewicz, RN, BSN 616-391-9369 alison.dutkiewicz@spectrum-health.org | |
Contact: Curt Gritters, RN, BSN 616-391-5083 curtis.gritters@spectrum-health.org | |
Principal Investigator: Anthony J. Senagore, MD, MS, MBA | |
Sub-Investigator: Dan Metcalf, MD | |
Sub-Investigator: Martin Luchtefeld, MD | |
Sub-Investigator: Donald Kim, MD | |
Sub-Investigator: Nadav Dujovny, MD | |
Sub-Investigator: Rebecca Hoedema, MD | |
Sub-Investigator: Heather Slay, MD | |
Sub-Investigator: Ryan Figg, MD | |
United States, Minnesota | |
Mayo Clinic-Division of Colon and Rectal Surgery | Not yet recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Sharlene Allen, RN, CCRP Allen.Sharlene@mayo.edu | |
Principal Investigator: Eric Dozois, MD, FACS, FASCRS | |
Sub-Investigator: David Larson, MD | |
Sub-Investigator: Robert Cima, MD | |
Sub-Investigator: Bruce Wolf, MD | |
Sub-Investigator: Rick Devine, MD | |
Sub-Investigator: Heidi Chua, MD | |
United States, New York | |
New York Presbyterian Hospital | Not yet recruiting |
New York, New York, United States, 10032 | |
Contact: Danny Feingold, MD 212-342-1155 | |
Principal Investigator: Richard L. Whelan, MD | |
Sub-Investigator: Danny Feingold, MD | |
United States, Ohio | |
University Hospitals of Cleveland, Case Medical Center | Not yet recruiting |
Cleveland, Ohio, United States, 44106-5047 | |
Contact: Bridget Ermlich, RN, BSN, CWCN, COCN 216-844-8087 Bridget.Ermlich@uhhospitals.org | |
Principal Investigator: Conor P. Delaney, MD, PhD | |
Sub-Investigator: Brad Champagne, MD | |
Sub-Investigator: Harry Reynolds, MD | |
Sub-Investigator: vinvent Obias, MD | |
Sub-Investigator: Eric Marderstein, MD | |
United States, Texas | |
Texas Endosurgery Institute | Recruiting |
San Antonio, Texas, United States, 78222 | |
Contact: Guillermo Portillo, MD drguillermoportillo@gmail.com | |
Principal Investigator: Morris Franklin, MD | |
Sub-Investigator: Jeffrey Glass, MD, FACS | |
Sub-Investigator: Guillermo Portillo, MD | |
United States, Utah | |
University of Utah Hospitals and Clinics-Colon and Rectal Surgery | Not yet recruiting |
Salt Lake City, Utah, United States, 84132 | |
Contact: Mary Mone 801-581-7124 mary.mone@hsc.utah.edu | |
Principal Investigator: Bradford Sklow, MD |
Principal Investigator: | Anthony Senagore, MD, MBA, MS | Spectrum Health Hospitals |
Responsible Party: | Spectrum Health ( Anthony J. Senagore, MD, MBA, MS ) |
Study ID Numbers: | 2008-109, CS150 |
Study First Received: | April 18, 2008 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00663819 |
Health Authority: | United States: Institutional Review Board |
Ileostomy Colorectal Surgery Proctectomy Anastomosis Rectal Cancer |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Rectal Neoplasms Gastrointestinal Neoplasms Intestinal Diseases |
Rectal cancer Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms Rectal neoplasm |
Neoplasms Neoplasms by Site |