Use of a Biological Mesh (StratticeTM) for the Prevention of Parastomal Hernia After Colorectal Surgery With Colostomy

Prospective, Multicenter, Randomized, Parallel Group Clinical Study Evaluating the Efficacy of a Biological Mesh (StratticeTM) for the Prevention of Parastomal Hernia After Colorectal Surgery With Colostomy

In France around 5,000 colostomies are performed after elective or emergency surgery. These colostomies could be associated with major outcomes including parastomal hernia (4 - 53%) of cases.

To reduce the incidence of these outcomes, several methods have been proposed but the more pertinent consist in the use of a biological mesh during the stoma's conception.

Nevertheless there is no data on the use of a biological mesh (StratticeTM) for the prevention of parastomal hernia.

Inclusion Criteria:

• Patient requiring a colorectal surgery with a terminal colostomy
• Elective or emergency surgery

Exclusion Criteria:

• Has collagen-vascular, connective tissue, or uncorrectable bleeding disorders as determined clinically by the PI.
• Has any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.
• Has an autoimmune disease, an immune deficiency, or is on immune suppression drugs
• Is pregnant, or lactating.
• Allergic to any porcine or collagen products.
• survival < 6 months