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

March 9, 2023 updated by: Centre Hospitalier Universitaire, Amiens

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Amiens University Hospital
      • Amiens, France
        • Amiens Universitary Hospital
      • Beauvais, France
        • Beauvais hospital
      • Caen, France
        • Caen Hospital
      • Lille, France
        • Claude Huriet Hospital
      • Paris, France
        • Lariboisiere Hospital
      • Rouen, France
        • Charles Nicolle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Strattice
a strattice (10 x 10) will be used during the surgery, prior to the colostomy's conception
Device: strattice
use of a strattice
Placebo Comparator: No strattice
the colostomy is not reinforced with a mesh
Procedure: No strattice
no use of a strattice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of parastomal hernia
Time Frame: postoperative month 6
the presence of a parastomal hernia will be diagnosed either by the clinical examination either by a CT scan
postoperative month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of the pain
Time Frame: 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
2 years after the surgery
the postoperative morbidity
Time Frame: postoperative month 1
the postoperative morbidity will be assessed with the Dindo Clavien classification
postoperative month 1
the parastomal hernia rate
Time Frame: postoperative year 1
The parastomal hernia rate will be evaluated 1 year after the surgery during the clinical examination
postoperative year 1
the quality of life
Time Frame: 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
2 years after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Collaborators

LifeCell

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2014

Primary Completion (Actual)

December 1, 2018

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

April 22, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (Estimate)

April 23, 2014

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2014_843_0001
  • 2013-A01461-44 (Other Identifier: ID-RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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