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| Sponsors and Collaborators: |
Spectrum Health Hospitals W.L.Gore & Associates |
| Information provided by: | Spectrum Health Hospitals |
| ClinicalTrials.gov Identifier: | NCT00663819 |
Purpose
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 |
|
Ileostomy Colorectal Surgery Proctectomy Anastomosis Rectal Cancer |
Device: GORE SEAMGUARD® |
| MedlinePlus related topics: | Cancer |
| 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 |
|
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
|
Device: GORE SEAMGUARD®
The rates of anastomotic leaks will be compared using standard stapling anastomosis versus the GORE SEAMGUARD® anastomoses.
|
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |||||
| Spectrum Health Hospitals |
| W.L.Gore & Associates |
| Principal Investigator: | Anthony Senagore, MD, MBA, MS | Spectrum Health Hospitals |
More Information
| Responsible Party: | Spectrum Health ( Anthony J. Senagore, MD, MBA, MS ) |
| Study ID Numbers: | 2008-109, CS150 |
| First Received: | April 18, 2008 |
| Last Updated: | May 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00663819 |
| Health Authority: | United States: Institutional Review Board |
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