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

Centre Hospitalier Universitaire, Amiens

Status: Active, not recruiting

Conditions: Terminal Colostomy; Parastomal Hernia

Treatments: Device: strattice; Procedure: No strattice

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02121743

2013-A01461-44 (Other Identifier)

PI2014_843_0001

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups, including a placebo group

Strattice

Experimental group

Description:

a strattice (10 x 10) will be used during the surgery, prior to the colostomy's conception

Treatment:

Device: strattice

No strattice

Placebo Comparator group

Description:

the colostomy is not reinforced with a mesh

Treatment:

Procedure: No strattice