NCT02121743

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parastomal Hernia
• Terminal Colostomy

Interventions

Type	Name	Description
DEVICE	strattice	use of a strattice
PROCEDURE	No strattice	no use of a strattice

Timeline

• Start date: 2014-04-14
• Primary completion: 2018-12-01
• Completion: 2023-12-01
• First posted: 2014-04-23
• Last updated: 2023-03-13

Locations

7 sites across 1 country: France