HerniaPhase 3NCT00496418
Peristomal Mesh for Prophylaxis of Parastomal Hernia
A Phase 3 study testing Mesh in permanent colostomy in people with Hernia, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The study aims to prove differences or equalities in outcome for patients operated with or without a peristomal mesh in the sublay position when establishing a permanent colostomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hernia
- What is being tested?
- Mesh in permanent colostomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Jul 2007to Nov 2014
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Condition with indication for establishing a permanent end-colostomy.
Who cannot join
- Age under 18
- ASA score above 3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Open Interventional Study for Evaluation of Use of Peristomal Mesh for Prophylaxis of Parastomal Hernia
The study aims to prove differences or equalities in outcome for patients operated with or without a peristomal mesh in the sublay position when establishing a permanent colostomy.
Read the detailed description
Patients are randomized to 2 groups equal in number: a group with mesh implantation and a control group without mesh implantation.
Primary endpoint is Parastomal hernia. Secondary endpoints are operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy. Patients are followed 4 years after operation with clinical examination
- Conditions
- Hernia
- Being tested
- Mesh in permanent colostomy
- Keywords
- colostomy, parastomal, peristomal, hernia, mesh, surgery, Indication for permanent end colostomy
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesh in permanent colostomyDevice
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic stoma mesh | Experimental | Mesh Receives: Device: Mesh in permanent colostomy |
| No mesh prophylaxis | Active comparator | No mesh Receives: Device: Mesh in permanent colostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parastomal hernia
Measured: at 3, 12, 24, 36 and 48 months
Secondary outcomes (1)
Operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionSep 2011
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HerniaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Lambrecht, Oslo University Hospital
- Investigators
- Jan Lambrecht, MD, Principal investigator, Rikshospitalet-Radiumhospitalet HF, Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496418
- Sponsor's protocol ID
- S-07203a
- Status last verified
- Jan 2015
- First submitted
- 3 Jul 2007
- Last updated
- 14 Jan 2015
- Results posted
- No
Publications
Lambrecht JR. Diagnostic methods in parastomal hernia; research and clinical relevance. Hernia. 2021 Jun;25(3):817-820. doi: 10.1007/s10029-020-02177-8. Epub 2020 Mar 28. No abstract available.
PubMed 32222841
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Open Interventional Study for Evaluation of Use of Peristomal Mesh for Prophylaxis of Parastomal Hernia
- ClinicalTrials.gov ID
- NCT00496418
- Acronym / sponsor ID
- S-07203a
- Conditions
- Hernia
- Keywords
- colostomy, parastomal, peristomal, hernia, mesh, surgery, Indication for permanent end colostomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 4 Jul 2007 (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.
The study aims to prove differences or equalities in outcome for patients operated with or without a peristomal mesh in the sublay position when establishing a permanent colostomy.
Detailed description
Patients are randomized to 2 groups equal in number: a group with mesh implantation and a control group without mesh implantation.
Primary endpoint is Parastomal hernia. Secondary endpoints are operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy. Patients are followed 4 years after operation with clinical examination
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic stoma mesh | Experimental | Device: Mesh in permanent colostomyMesh |
| No mesh prophylaxis | Active comparator | Device: Mesh in permanent colostomyNo mesh |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Condition with indication for establishing a permanent end-colostomy.
Key exclusion criteria (2 listed)
- Age under 18
- ASA score above 3
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 |
|---|---|---|
| Mesh in permanent colostomy | Device | No mesh prophylaxis, Prophylactic stoma mesh |
Primary outcome
Parastomal hernia
Time frame: at 3, 12, 24, 36 and 48 months
1 secondary outcome
Operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy
Time frame: 4 years
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 14 Jan 2015.
- Derived from this study: PubMed 32222841Lambrecht JR. Diagnostic methods in parastomal hernia; research and clinical relevance. Hernia. 2021 Jun;25(3):817-820. doi: 10.1007/s10029-020-02177-8. Epub 2020 Mar 28. No abstract available.
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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.
Jan Lambrecht, MD principal investigator
Rikshospitalet-Radiumhospitalet HF, Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mesh in permanent colostomy in people with Hernia, run by Oslo University Hospital at 1 site in Norway.
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 1 inclusion and 2 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 14 Jan 2015. 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 Norway. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Parastomal hernia (time frame: at 3, 12, 24, 36 and 48 months). 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 NCT00496418, which also lists 1 linked publication.
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 14 Jan 2015.