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COMPLETED
NCT02121743
NA

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

Sponsor: Centre Hospitalier Universitaire, Amiens

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

81

Start Date

2014-04-14

Completion Date

2025-12-09

Last Updated

2026-06-12

Healthy Volunteers

No

Interventions

DEVICE

strattice

use of a strattice

PROCEDURE

No strattice

no use of a strattice

Locations (7)

Amiens Universitary Hospital

Amiens, France

Amiens university hospital

Amiens, France

Beauvais hospital

Beauvais, France

Caen hospital

Caen, France

Claude Huriet Hospital

Lille, France

Lariboisiere Hospital

Paris, France

Charles Nicolle Hospital

Rouen, France