Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal and Coloanal Anastomoses: A Prospective Randomized Study - Full Text View

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 Surgery

U.S. FDA Resources

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

Further study details as provided by Spectrum Health Hospitals:

Primary Outcome Measures:

Determine the clinical and radiologic postoperative anastomotic leak rate in high-risk circular stapled colorectal and coloanal anastomoses using CBSG. [ Time Frame: completion of procedure and follow-up visits ] [ Designated as safety issue: No ]
Determine the time to ileostomy closure following diverted high-risk stapled circular colorectal and coloanal anastomoses with and without CBSG [ Time Frame: completion of procedure and follow-up visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Identify and compare the rate of anastomotic stenosis associated with circular stapled anastomoses constructed with and without CBSG. [ Time Frame: post operative ] [ Designated as safety issue: No ]
Determine the rate of significant staple line hemorrhage with and without the use of CBSG in circular stapled anastomoses [ Time Frame: post operative ] [ Designated as safety issue: No ]
Provide a cost/benefit analysis with regard to the use of CBSG in stapled circular anastomoses [ Time Frame: study completion ] [ Designated as safety issue: No ]
Determine the efficacy and further substantiate safety of CBSG used in conjunction with circular staplers when performing high-risk colorectal and coloanal anastomoses. [ Time Frame: study completion ] [ Designated as safety issue: No ]

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	Device: GORE SEAMGUARD® The rates of anastomotic leaks will be compared using standard stapling anastomosis versus the GORE SEAMGUARD® anastomoses.
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.

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 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

Criteria

Inclusion Criteria:

Subjects who will undergo preoperative chemoradiation therapy in the treatment of their rectal cancer.
Subjects who will have a diverting loop ileostomy as a component of their initial surgery for rectal cancer.
Subjects that will undergo restorative proctectomy with a low circular stapled colorectal or coloanal anastomosis (<10cm from the anal verge) with or without reservoir.

Exclusion Criteria:

Subjects 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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663819

Contacts

Contact: Linda Lamphere	928-864-3439	llampher@wlgore.com
Contact: Jason Smith	610-675-6135	jsmith@wlgore.com

Locations

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

Sponsors and Collaborators

Spectrum Health Hospitals

W.L.Gore & Associates

Investigators

Principal Investigator:

Anthony Senagore, MD, MBA, MS

Spectrum Health Hospitals

More Information

No publications provided

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 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Spectrum Health Hospitals:

Ileostomy
Colorectal Surgery
Proctectomy
Anastomosis
Rectal Cancer

Study placed in the following topic categories:

Rectal Cancer
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Rectal Neoplasm

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009