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

This study is currently recruiting participants.
Study NCT00663819.   Last updated on May 20, 2008.   Information provided by Spectrum Health Hospitals

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Descriptive Information Fields
Brief Title  Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal and Coloanal Anastomoses: A Prospective Randomized Study
Official Title  Efficacy of Bioabsorbable Staple Line Reinforcement in Colorectal and Coloanal Anastomoses: A Prospective Randomized Study
Brief Summary

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.

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.

Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  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 Measure  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 ]
Condition  Ileostomy
Colorectal Surgery
Proctectomy
Anastomosis
Rectal Cancer
Intervention  Device: GORE SEAMGUARD®
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  750
Start Date  April 2008
Completion Date December 2011
Eligibility 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).
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Linda Lamphere     928-864-3439     llampher@wlgore.com    
Contact: Jason Smith     610-675-6135     jsmith@wlgore.com    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00663819
Organization ID 2008-109
Secondary IDs †† CS150
Study Sponsor  Spectrum Health Hospitals
Collaborators †† W.L.Gore & Associates
Investigators 
Principal Investigator:     Anthony Senagore, MD, MBA, MS     Spectrum Health Hospitals    
Information Provided By Spectrum Health Hospitals
Verification Date May 2008
First Received Date  April 18, 2008
Last Updated Date May 20, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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