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

Not Applicable

Active, not recruiting

• Conditions: Parastomal Hernia; Terminal Colostomy
• Interventions: Device: strattice; Procedure: No strattice

• Registration Number: NCT02121743
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-14
• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-23
• Primary Completion: 2018-12-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-13
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Strattice	strattice	a strattice (10 x 10) will be used during the surgery, prior to the colostomy's conception
No strattice	No strattice	the colostomy is not reinforced with a mesh

Primary Outcome Measures

Name	Time	Method
rate of parastomal hernia	postoperative month 6	the presence of a parastomal hernia will be diagnosed either by the clinical examination either by a CT scan

Secondary Outcome Measures

Name	Time	Method
the postoperative morbidity	postoperative month 1	the postoperative morbidity will be assessed with the Dindo Clavien classification
the parastomal hernia rate	postoperative year 1	The parastomal hernia rate will be evaluated 1 year after the surgery during the clinical examination
the quality of life	2 years after the surgery	The quality of life will be assessed with the STOMA QoL form, the 12-Item Short Form Health Survey (SF12) and the Carolina comfort scale at 1 month, 6 months, 1 year and 2 years after the surgery
evaluation of the pain	2 years after the surgery	The pain will be evaluated with a visual scale 1 month, 6 months, 1 year and 2 years after the surgery

Trial Locations

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