Parastomal HerniaPREVEMACNCT06533839
Prevention of Parastomal Hernias With a Preformed Three-dimensional, Funnel-shaped Mesh
A study testing Permanent colostomy in people with Parastomal Hernia, run by Consorci Sanitari Integral at 1 site in Spain.
Trial summary
Parastomal hernia (PH) remains a significant complication following stoma creation, boasting a considerable prevalence in the range of 30 to 50% within the first year post-surgery, a figure that climbs even higher when considering radiological evidence irrespective of clinical symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parastomal Hernia
- What is being tested?
- Permanent colostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2024to 1 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients undergoing a definitive colostomy confection
- Terminal colostomy confection
- ASA index III or inferior
- Patients who have given legat authorization to participate in the study
Who cannot join
- Lateral colostomy or a colostomy that will be removed posteriorly
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona, 08970
Laura Sobrerroca Porras, MD, lsobrerrocap@csi.cat
Jesús Badia Closa, jbadiac@csi.cat
About this study
Official title: Prevention of Parastomal Hernias With a Preformed Three-dimensional, Funnel-shaped Mesh. A Prospective, Multicenter and Randomized Study (PREVEMAC)
Parastomal hernia (PH) remains a significant complication following stoma creation, boasting a considerable prevalence in the range of 30 to 50% within the first year post-surgery, a figure that climbs even higher when considering radiological evidence irrespective of clinical symptoms. A noteworthy one-third of these cases necessitate subsequent surgical interventions, yielding suboptimal outcomes both in the short and long term. The clinical manifestations of PH are diverse, ranging from mild inconveniences like fecal leakage and dermatitis to more severe and potentially life-threatening complications such as intestinal obstruction, hernia incarceration, and ischemia.
Various systematic reviews and meta-analyses have advocated for the adoption of prophylactic meshes, although defining precise incidence and recurrence rates has proven challenging due to methodological disparities across studies. Keyhole and modified Sugarbaker techniques dominate laparoscopic and robotic approaches, yet none offer ideal outcomes.
The aim of this study is to evaluate the decrease of postoperative parastomal hernia using this three-dimensional, funnel-shaped mesh.
- Conditions
- Parastomal Hernia
- Being tested
- Permanent colostomy
- Keywords
- Parastomal hernia, end colostomy, prophylactic mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permanent colostomyProcedure or surgery
A long-term (permanent) colostomy will be performed in the diseased colon or rectum.
| Study group | Role | What they receive |
|---|---|---|
| IPST mesh placement | Experimental | A three-dimensional, funnel-shaped mesh will be used. Receives: Procedure: Permanent colostomy |
| No mesh | Active comparator | No mesh will be applied. Receives: Procedure: Permanent colostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative parastomal hernia prevention
proportion of Postoperative parastomal hernias
Measured: up to one year post-intervention
Secondary outcomes (3)
Postoperative parastomal hernia prevention
proportion of Postoperative parastomal hernias
Measured: 5 years after surgery
readmissions for complications
proportion of hospital readmissions
Measured: up to one year post-intervention
morbidity
Comprehensive Complication Index (CCI) 20
Measured: up to one year post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parastomal HerniaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari Integral
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533839
- Sponsor's protocol ID
- 24/20
- Acronym
- PREVEMAC
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Parastomal Hernias With a Preformed Three-dimensional, Funnel-shaped Mesh. A Prospective, Multicenter and Randomized Study (PREVEMAC)
- ClinicalTrials.gov ID
- NCT06533839
- Acronym / sponsor ID
- PREVEMAC / 24/20
- Conditions
- Parastomal Hernia
- Keywords
- Parastomal hernia, end colostomy, prophylactic mesh
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Consorci Sanitari IntegralUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 1 Aug 2024 (actual)
- 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.
Parastomal hernia (PH) remains a significant complication following stoma creation, boasting a considerable prevalence in the range of 30 to 50% within the first year post-surgery, a figure that climbs even higher when considering radiological evidence irrespective of clinical symptoms. A noteworthy one-third of these cases necessitate subsequent surgical interventions, yielding suboptimal outcomes both in the short and long term. The clinical manifestations of PH are diverse, ranging from mild inconveniences like fecal leakage and dermatitis to more severe and potentially life-threatening complications such as intestinal obstruction, hernia incarceration, and ischemia.
Various systematic reviews and meta-analyses have advocated for the adoption of prophylactic meshes, although defining precise incidence and recurrence rates has proven challenging due to methodological disparities across studies. Keyhole and modified Sugarbaker techniques dominate laparoscopic and robotic approaches, yet none offer ideal outcomes.
The aim of this study is to evaluate the decrease of postoperative parastomal hernia using this three-dimensional, funnel-shaped mesh.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Multicentric randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| IPST mesh placement | Experimental | Procedure: Permanent colostomyA three-dimensional, funnel-shaped mesh will be used. |
| No mesh | Active comparator | Procedure: Permanent colostomyNo mesh will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing a definitive colostomy confection
- Terminal colostomy confection
- ASA index III or inferior
- Patients who have given legat authorization to participate in the study
Key exclusion criteria (1 listed)
- Lateral colostomy or a colostomy that will be removed posteriorly
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 |
|---|---|---|
| Permanent colostomyA long-term (permanent) colostomy will be performed in the diseased colon or rectum. | Procedure or surgery | IPST mesh placement, No mesh |
Primary outcome
Postoperative parastomal hernia prevention
Time frame: up to one year post-intervention
proportion of Postoperative parastomal hernias
3 secondary outcomes
Postoperative parastomal hernia prevention
Time frame: 5 years after surgery
readmissions for complications
Time frame: up to one year post-intervention
morbidity
Time frame: up to one year post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Permanent colostomy in people with Parastomal Hernia, run by Consorci Sanitari Integral at 1 site in Spain.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Sobrerroca Porras, MD (+34935531200, lsobrerrocap@csi.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative parastomal hernia prevention (time frame: up to one year post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2024.