Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

This study has been terminated.
(Terminated at the first interim analysis in accordance with the power and enrollment calculations performed before the study began.)
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00663819
First received: April 18, 2008
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

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 staple line reinforcement material compared with standard non-reinforced colorectal, coloanal and ileoanal techniques with respect to the incidence of postoperative anastomotic leakage, anastomotic stricture and time to ileostomy closure, if applicable.


Condition Intervention
Ileostomy, When Applicable
Rectal Cancer, When Applicable
Ulcerative Colitis, FAP, Diverticulitis, Hartmann's Reversal
Device: GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers
Procedure: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal, Coloanal and Ileoanal Anastomoses: A Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Determine the clinical and radiologic postoperative anastomotic leak rate in high-risk circular stapled colorectal, coloanal,and ileoanal anastomoses using CBSG. [ Time Frame: completion of procedure and follow-up visits ] [ Designated as safety issue: No ]
  • Determine the time to ileostomy closure, if applicable following high-risk stapled circular colorectal, coloanal, and ileoanal 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, coloanal, and Ileoanal anastomoses. [ Time Frame: study completion ] [ Designated as safety issue: No ]

Enrollment: 258
Study Start Date: April 2008
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Circular stapler line reinforcement
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers used to reinforce anastomotic staple lines
Device: GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers
Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler
Active Comparator: Non-reinforced anastomotic staple line
Standard non-reinforced anastomotic staple lines
Procedure: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement
colorectal and coloanal anastomotic staple line without reinforcement

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, coloanal, and ileoanal 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 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36617
United States, California
University of Southern California, Keck School of Medicine
Los Angeles, California, United States, 90033
United States, Florida
University of South Florida-Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Illinois
Advocate Healthcare/Good Shepard Hospital
Barrington, Illinois, United States, 60010
John Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
Peoria Surgical Group
Peoria, Illinois, United States, 61606
United States, Indiana
Colon and Rectal Surgery-NEICRS Group
Fort Wayne, Indiana, United States, 46845
Kenderick Regional Center
Indianapolis, Indiana, United States, 46237
United States, Michigan
Spectrum Health -Ferguson Group
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Duluth Clinic
Duluth, Minnesota, United States, 55805
United States, New York
Albany Medical College
Albany, New York, United States, 12208
New York Presbyterian Hospital
New York, New York, United States, 10032
St. Lukes-Roosevelt Hospital Center
New York, New York, United States, 10019
United States, Ohio
University Hospitals of Cleveland, Case Medical Center
Cleveland, Ohio, United States, 44106-5047
United States, Texas
Texas Endosurgery Institute
San Antonio, Texas, United States, 78222
United States, Utah
University of Utah Health Sciences Center and Huntsman Cancer Hospital
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Anthony J Senagore, MD, MBA, MS University of Southern California, Keck School of Medicine
  More Information

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00663819     History of Changes
Other Study ID Numbers: 2008-109, CS150
Study First Received: April 18, 2008
Last Updated: April 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by W.L.Gore & Associates:
Low anterior colon resection
Proctectomy
Proctocolectomy
Anastomosis
Rectal Cancer
Ileostomy

Additional relevant MeSH terms:
Rectal Neoplasms
Colitis
Colitis, Ulcerative
Diverticulitis
Ulcer
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Gastroenteritis
Colonic Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014