Parastomal HerniaPROBIOCOLNCT02121743
Use of a Biological Mesh (StratticeTM) for the Prevention of Parastomal Hernia After Colorectal Surgery With Colostomy
A study testing strattice and No strattice in people with Parastomal Hernia and Terminal Colostomy, run by Centre Hospitalier Universitaire, Amiens at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parastomal Hernia, Terminal Colostomy
- What is being tested?
- strattice and No strattice
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 7 sitesFrance
- Study dates
- 14 Apr 2014to 9 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient requiring a colorectal surgery with a terminal colostomy
- Elective or emergency surgery
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Amiens Universitary Hospital
Amiens
Amiens university hospital
Amiens
Beauvais hospital
Beauvais
Caen hospital
Caen
Claude Huriet Hospital
Lille
Lariboisiere Hospital
Paris
Charles Nicolle Hospital
Rouen
About this study
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
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
- Being tested
- strattice, No strattice
- Keywords
- strattice, colostomy, parastomal hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stratticeDevice
use of a strattice
No stratticeProcedure or surgery
no use of a strattice
| Study group | Role | What they receive |
|---|---|---|
| Strattice | Experimental | a strattice (10 x 10) will be used during the surgery, prior to the colostomy's conception Receives: Device: strattice |
| No strattice | Placebo comparator | the colostomy is not reinforced with a mesh Receives: Procedure: No strattice |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of parastomal hernia
the presence of a parastomal hernia will be diagnosed either by the clinical examination either by a CT scan
Measured: postoperative month 6
Secondary outcomes (4)
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
Measured: 2 years after the surgery
the postoperative morbidity
the postoperative morbidity will be assessed with the Dindo Clavien classification
Measured: postoperative month 1
the parastomal hernia rate
The parastomal hernia rate will be evaluated 1 year after the surgery during the clinical examination
Measured: postoperative year 1
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
Measured: 2 years after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study start14 Apr 2014
- Primary completion25 Sep 2024
- Study completion9 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parastomal HerniaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- LifeCell
- Responsible party
- Sponsor
- Investigators
- jean marc regimbeau, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121743
- Sponsor's protocol ID
- PI2014_843_0001
- Other IDs
- 2013-A01461-44
- Acronym
- PROBIOCOL
- Status last verified
- Jun 2026
- First submitted
- 22 Apr 2014
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24238119Lee 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.
PubMed 24210147Swann 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.
PubMed 3374759
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02121743
- Acronym / sponsor ID
- PROBIOCOL / PI2014_843_0001
- Conditions
- Parastomal Hernia, Terminal Colostomy
- Keywords
- strattice, colostomy, parastomal hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- LifeCell
- Study start
- 14 Apr 2014 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strattice | Experimental | Device: stratticea strattice (10 x 10) will be used during the surgery, prior to the colostomy's conception |
| No strattice | Placebo comparator | Procedure: No stratticethe colostomy is not reinforced with a mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient requiring a colorectal surgery with a terminal colostomy
- Elective or emergency surgery
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stratticeuse of a strattice | Device | Strattice |
| No stratticeno use of a strattice | Procedure or surgery | No strattice |
Primary outcome
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
4 secondary outcomes
evaluation of the pain
Time frame: 2 years after the surgery
the postoperative morbidity
Time frame: postoperative month 1
the parastomal hernia rate
Time frame: postoperative year 1
the quality of life
Time frame: 2 years after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 24238119Timmermans 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.
- Background: PubMed 24210147Lee 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.
- Background: PubMed 3374759Swann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jean marc regimbeau, MD, PhD principal investigator
CHU Amiens
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing strattice and No strattice in people with Parastomal Hernia and Terminal Colostomy, run by Centre Hospitalier Universitaire, Amiens at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of parastomal hernia (time frame: postoperative month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02121743, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.