According to the gore® seamguard® bioabsorbable staple line reinforcement instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: infection, inflammation, adhesions and hematoma.
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The following publication which mentions gore® seamguard® bioabsorbable staple line reinforcement was reviewed: bioabsorbable staple line reinforcement in restorative proctectomy and anterior resection: a randomized study.
Background: anastomotic complications, including leaks, strictures/stenosis, and bleeding, cause considerable mortality and morbidity after colorectal surgery.
Methods: this study was conducted at 17 centers in the united states.
The 258 patients 123 in the reinforcement group (gore® seamguard® circular bioabsorbable staple line reinforcement) and 135 control subjects underwent surgery for a variety of conditions, but most (n = 200) were treated for rectal cancer.
A double-stapled, circular-stapler anastomosis was performed in all of the patients.
The diameter of the circular stapler (28 to 34 mm) was determined by the operating surgeon in each case.
Results: five patients in each group were found to have an anastomotic air leak at the time of surgery.
Three of the leaks in each group required repair; the other 2 did not.
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