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

Primary Purpose

Parastomal Hernia, Terminal Colostomy

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
strattice
No strattice
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parastomal Hernia focused on measuring strattice, colostomy, parastomal hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Amiens Universitary Hospital
  • Amiens university hospital
  • Beauvais hospital
  • Caen hospital
  • Claude Huriet Hospital
  • Lariboisiere Hospital
  • Charles Nicolle Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Strattice

No strattice

Arm Description

a strattice (10 x 10) will be used during the surgery, prior to the colostomy's conception

the colostomy is not reinforced with a mesh

Outcomes

Primary Outcome Measures

rate of parastomal hernia
the presence of a parastomal hernia will be diagnosed either by the clinical examination either by a CT scan

Secondary Outcome Measures

evaluation of the pain
The pain will be evaluated with a visual scale 1 month, 6 months, 1 year and 2 years after the surgery
the postoperative morbidity
the postoperative morbidity will be assessed with the Dindo Clavien classification
the parastomal hernia rate
The parastomal hernia rate will be evaluated 1 year after the surgery during the clinical examination
the quality of life
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

Full Information

First Posted
April 22, 2014
Last Updated
March 9, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
LifeCell
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1. Study Identification

Unique Protocol Identification Number
NCT02121743
Brief Title
Use of a Biological Mesh (StratticeTM) for the Prevention of Parastomal Hernia After Colorectal Surgery With Colostomy
Acronym
PROBIOCOL
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 14, 2014 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
LifeCell

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parastomal Hernia, Terminal Colostomy
Keywords
strattice, colostomy, parastomal hernia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strattice
Arm Type
Experimental
Arm Description
a strattice (10 x 10) will be used during the surgery, prior to the colostomy's conception
Arm Title
No strattice
Arm Type
Placebo Comparator
Arm Description
the colostomy is not reinforced with a mesh
Intervention Type
Device
Intervention Name(s)
strattice
Intervention Description
use of a strattice
Intervention Type
Procedure
Intervention Name(s)
No strattice
Intervention Description
no use of a strattice
Primary Outcome Measure Information:
Title
rate of parastomal hernia
Description
the presence of a parastomal hernia will be diagnosed either by the clinical examination either by a CT scan
Time Frame
postoperative month 6
Secondary Outcome Measure Information:
Title
evaluation of the pain
Description
The pain will be evaluated with a visual scale 1 month, 6 months, 1 year and 2 years after the surgery
Time Frame
2 years after the surgery
Title
the postoperative morbidity
Description
the postoperative morbidity will be assessed with the Dindo Clavien classification
Time Frame
postoperative month 1
Title
the parastomal hernia rate
Description
The parastomal hernia rate will be evaluated 1 year after the surgery during the clinical examination
Time Frame
postoperative year 1
Title
the quality of life
Description
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
Time Frame
2 years after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jean marc regimbeau, MD, PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amiens Universitary Hospital
City
Amiens
Country
France
Facility Name
Amiens university hospital
City
Amiens
Country
France
Facility Name
Beauvais hospital
City
Beauvais
Country
France
Facility Name
Caen hospital
City
Caen
Country
France
Facility Name
Claude Huriet Hospital
City
Lille
Country
France
Facility Name
Lariboisiere Hospital
City
Paris
Country
France
Facility Name
Charles Nicolle Hospital
City
Rouen
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
24238119
Citation
Timmermans L, Deerenberg EB, Lamme B, Jeekel J, Lange JF. Parastomal hernia is an independent risk factor for incisional hernia in patients with end colostomy. Surgery. 2014 Jan;155(1):178-83. doi: 10.1016/j.surg.2013.06.014. Epub 2013 Nov 12.
Results Reference
background
PubMed Identifier
24210147
Citation
Lee L, Saleem A, Landry T, Latimer E, Chaudhury P, Feldman LS. Cost effectiveness of mesh prophylaxis to prevent parastomal hernia in patients undergoing permanent colostomy for rectal cancer. J Am Coll Surg. 2014 Jan;218(1):82-91. doi: 10.1016/j.jamcollsurg.2013.09.015. Epub 2013 Sep 29.
Results Reference
background
PubMed Identifier
3374759
Citation
Swann JM, Turek FW. Transfer from long to short days reduces the frequency of pulsatile luteinizing hormone release in intact but not in castrated male golden hamsters. Neuroendocrinology. 1988 Apr;47(4):343-9. doi: 10.1159/000124935.
Results Reference
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Use of a Biological Mesh (StratticeTM) for the Prevention of Parastomal Hernia After Colorectal Surgery With Colostomy

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