Back to resultsBioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses
Primary Purpose
Rectal Cancer, Ulcerative Colitis, Familial Adenomatous Polyposis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement
Staple line without reinforcement
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring Low anterior colon resection, Proctectomy, Proctocolectomy, Anastomosis, Rectal Cancer, Ileostomy
Eligibility 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, familial adenomatous polyposis
, 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).
Sites / Locations
- University of South Alabama
- University of Southern California, Keck School of Medicine
- University of South Florida-Cleveland Clinic Florida
- Advocate Healthcare/Good Shepard Hospital
- John Stroger Hospital of Cook County
- Peoria Surgical Group
- Colon and Rectal Surgery-NEICRS Group
- Kenderick Regional Center
- Spectrum Health -Ferguson Group
- Duluth Clinic
- Albany Medical College
- St. Lukes-Roosevelt Hospital Center
- New York Presbyterian Hospital
- University Hospitals of Cleveland, Case Medical Center
- Texas Endosurgery Institute
- University of Utah Health Sciences Center and Huntsman Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Device
Procedure/Surgery
Arm Description
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers
Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement
Outcomes
Primary Outcome Measures
Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak
The primary endpoint for the study is the proportion of subjects who experience a clinical and/or radiologic anastomotic leak through 4 - 12 weeks post procedure.
Secondary Outcome Measures
Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG.
Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses
Determine the Efficacy and Further Substantiate Safety of CBSG Used in Conjunction With Circular Staplers When Performing High-risk Colorectal, Coloanal, and Ileoanal Anastomoses.
Compare th number of patients experiencing significant post-operative complications when performing high-risk colorectal, coloanal, and Ileoanal anastomoses across both groups studied.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00663819
Brief Title
Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses
Official Title
Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal, Coloanal and Ileoanal Anastomoses: A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Per SAP
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
W.L.Gore & Associates
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Ulcerative Colitis, Familial Adenomatous Polyposis, Diverticulitis
Keywords
Low anterior colon resection, Proctectomy, Proctocolectomy, Anastomosis, Rectal Cancer, Ileostomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
258 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device
Arm Type
Active Comparator
Arm Description
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular staplers
Arm Title
Procedure/Surgery
Arm Type
Other
Arm Description
Procedure/Surgery: colorectal, coloanal, and ileoanal anastomotic staple line without reinforcement
Intervention Type
Device
Intervention Name(s)
GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement
Intervention Description
Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler
Intervention Type
Procedure
Intervention Name(s)
Staple line without reinforcement
Intervention Description
colorectal and coloanal anastomotic staple line without reinforcement
Primary Outcome Measure Information:
Title
Proportion of Subjects Who Experience a Clinical and/or Radiologic Anastomotic Leak
Description
The primary endpoint for the study is the proportion of subjects who experience a clinical and/or radiologic anastomotic leak through 4 - 12 weeks post procedure.
Time Frame
Completion of procedure through 4-12 weeks post procedure
Secondary Outcome Measure Information:
Title
Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG.
Time Frame
Post operative
Title
Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses
Time Frame
Post operative
Title
Determine the Efficacy and Further Substantiate Safety of CBSG Used in Conjunction With Circular Staplers When Performing High-risk Colorectal, Coloanal, and Ileoanal Anastomoses.
Description
Compare th number of patients experiencing significant post-operative complications when performing high-risk colorectal, coloanal, and Ileoanal anastomoses across both groups studied.
Time Frame
Within 4 - 12 weeks post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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, familial adenomatous polyposis
, 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony J Senagore, MD, MBA, MS
Organizational Affiliation
University of Southern California, Keck School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
University of Southern California, Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of South Florida-Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Advocate Healthcare/Good Shepard Hospital
City
Barrington
State/Province
Illinois
ZIP/Postal Code
60010
Country
United States
Facility Name
John Stroger Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Peoria Surgical Group
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61606
Country
United States
Facility Name
Colon and Rectal Surgery-NEICRS Group
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Kenderick Regional Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Spectrum Health -Ferguson Group
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Duluth Clinic
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
St. Lukes-Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University Hospitals of Cleveland, Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5047
Country
United States
Facility Name
Texas Endosurgery Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78222
Country
United States
Facility Name
University of Utah Health Sciences Center and Huntsman Cancer Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses
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