Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

Ulcerative Colitis Clinical Trial

Official title:

Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal, Coloanal and Ileoanal Anastomoses: A Prospective Randomized Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00663819
• Other study ID #: 2008-109
• Secondary ID: CS150
• Status: Terminated
• Phase: N/A
• First received: April 18, 2008
• Last updated: March 16, 2018
• Start date: April 2008
• Est. completion date: October 2012

Study information

• Verified date: March 2018
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 258
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Adenomatous Polyposis Coli
• Colitis, Ulcerative
• Diverticulitis
• Familial Adenomatous Polyposis
• Rectal Cancer
• Rectal Neoplasms
• Ulcerative Colitis

Intervention

Device:
• GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement
Colorectal, coloanal, and ileoanal anastomotic staple line reinforcement with GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement configured for circular stapler

Procedure:
• Staple line without reinforcement
colorectal and coloanal anastomotic staple line without reinforcement

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	Advocate Healthcare/Good Shepard Hospital	Barrington	Illinois
United States	John Stroger Hospital of Cook County	Chicago	Illinois
United States	University Hospitals of Cleveland, Case Medical Center	Cleveland	Ohio
United States	Duluth Clinic	Duluth	Minnesota
United States	Colon and Rectal Surgery-NEICRS Group	Fort Wayne	Indiana
United States	Spectrum Health -Ferguson Group	Grand Rapids	Michigan
United States	Kenderick Regional Center	Indianapolis	Indiana
United States	University of Southern California, Keck School of Medicine	Los Angeles	California
United States	University of South Alabama	Mobile	Alabama
United States	New York Presbyterian Hospital	New York	New York
United States	St. Lukes-Roosevelt Hospital Center	New York	New York
United States	Peoria Surgical Group	Peoria	Illinois
United States	University of Utah Health Sciences Center and Huntsman Cancer Hospital	Salt Lake City	Utah
United States	Texas Endosurgery Institute	San Antonio	Texas
United States	University of South Florida-Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Completion of procedure through 4-12 weeks post procedure
Secondary	Identify and Compare the Rate of Anastomotic Stenosis Associated With Circular Stapled Anastomoses Constructed With and Without CBSG.		Post operative
Secondary	Determine the Rate of Significant Staple Line Hemorrhage With and Without the Use of CBSG in Circular Stapled Anastomoses		Post operative
Secondary	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.	Within 4 - 12 weeks post-surgery