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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-14

Study Completion Date

2023-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Parastomal Hernia Terminal Colostomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Strattice

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

Group Type EXPERIMENTAL

strattice

Intervention Type DEVICE

use of a strattice

No strattice

the colostomy is not reinforced with a mesh

Group Type PLACEBO_COMPARATOR

No strattice

Intervention Type PROCEDURE

no use of a strattice

Interventions

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strattice

use of a strattice

Intervention Type DEVICE

No strattice

no use of a strattice

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No