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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. |
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| 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. |
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| 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 ] |
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| 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 ] |
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| Condition † | Ileostomy Colorectal Surgery Proctectomy Anastomosis Rectal Cancer |
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| 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:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| 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 † |
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| Information Provided By | Spectrum Health Hospitals | ||||||||
| Verification Date | May 2008 | ||||||||
| First Received Date † | April 18, 2008 | ||||||||
| Last Updated Date | May 20, 2008 | ||||||||