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

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ClinicalTrials.gov Identifier: NCT02121743
Recruitment Status : Active, not recruiting
First Posted : April 23, 2014
Last Update Posted : March 13, 2023
Sponsor:
Collaborator:
LifeCell
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Study Description
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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.


Condition or disease Intervention/treatment Phase
Parastomal Hernia Terminal Colostomy Device: strattice Procedure: No strattice Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : April 14, 2014
Actual Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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. the postoperative morbidity [ Time Frame: postoperative month 1 ]
    the postoperative morbidity will be assessed with the Dindo Clavien classification

  3. 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

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121743


Locations
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France
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
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
LifeCell
Investigators
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Principal Investigator: jean marc regimbeau, MD, PhD CHU Amiens
More Information
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Publications:

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02121743    
Other Study ID Numbers: PI2014_843_0001
2013-A01461-44 ( Other Identifier: ID-RCB )
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: March 13, 2023
Last Verified: March 2023
Keywords provided by Centre Hospitalier Universitaire, Amiens:
strattice
colostomy
parastomal hernia
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical