Parastomal HerniaPhase 2/3NCT00641342
Prevention of Parastomal Hernia by Primary Mesh Insertion
A Phase 2/3 study testing onlay mesh in people with Parastomal Hernia, run by University Hospital, Gentofte, Copenhagen at 2 sites in Denmark.
Trial summary
Approximately 1/3 of patients with a permanent end-colostomy will experience a hernia around the stoma. In some cases these problems result in the need of surgical correction and the risk of recurrent hernia after operative intervention is regrettably high. 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?
- onlay mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 2 sitesDenmark
- Study dates
- Mar 2007to Feb 2015
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Permanent end-colostomy after surgery for rectosigmoid cancer with extirpation or Hartmann's procedure.
Who cannot join
- ASA > 3
- Acute surgery
- Known immune deficiency
- Surgery with insertion of foreign body (orthopaedic prosthesis, mechanical or bio-logical heart valve etc.) within the last 3 months.
- Pregnancy
- Known inflammatory bowel disease
- Lack of written informed consent
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Copenhagen University Hospital, Gentofte
Hellerup, Copenhagen, 2900
Copenhagen University Hospital, Hvidovre
Hvidovre, Copebhagen, 2630
About this study
Official title: Prevention of Parastomal Hernia by Primary Mesh Insertion: a Randomized Double-blinded Controlled Multi-centre Study.
Approximately 1/3 of patients with a permanent end-colostomy will experience a hernia around the stoma. In some cases these problems result in the need of surgical correction and the risk of recurrent hernia after operative intervention is regrettably high. Preliminary investigations suggest a role for primary mesh placement to prevent parastomal hernia. The use of a mesh as a preventive measure is a safe procedure. This study will focus on the effect of primary mesh placement (two different operative procedures are used) compared to patients without mesh placement.
- Conditions
- Parastomal Hernia
- Being tested
- onlay mesh
- Keywords
- Parastomal hernia, Onlay mesh, Sublay mesh, Pain, Health questionnaire
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onlay meshDevice
StomaMesh (Precut heavyweight polypropylene mesh) Vypro Mesh (lightweight Prolene and vicryl mesh)
| Study group | Role | What they receive |
|---|---|---|
| onlay mesh | Active comparator | Not described Receives: Device: onlay mesh |
| sublay mesh | Active comparator | Not described Receives: Device: onlay mesh |
| no mesh | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parastomal hernia verified by CT-scan
Measured: one year after surgery, reassessed after 2, 3 and 5 years
Secondary outcomes (3)
Clinically detected parastomal hernia
Measured: one year after surgery, reassessed after 2, 3 and 5 years
Pain
Measured: one year after surgery, reassessed after 2, 3 and 5 years
Disease specific and general health questionnaire
Measured: one year after surgery, reassessed after 2, 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startMar 2007
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Why it stopped: Lack of recruitment from different study sites and due to structural changes in the included centers
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Hvidovre University Hospital, Copenhagen University Hospital at Herlev, Esbjerg Hospital - University Hospital of Southern Denmark, Hillerod Hospital, Denmark, Vejle Hospital, Zealand University Hospital
- Responsible party
- Principal investigator, Ismail Gögenur, University Hospital, Gentofte, Copenhagen
- Investigators
- Ismail Gögenur, Principal investigator, University Hospital of Copenhagen, GEntofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641342
- Sponsor's protocol ID
- PMPC
- Status last verified
- Mar 2008
- First submitted
- 18 Mar 2008
- Last updated
- 7 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Parastomal Hernia by Primary Mesh Insertion: a Randomized Double-blinded Controlled Multi-centre Study.
- ClinicalTrials.gov ID
- NCT00641342
- Acronym / sponsor ID
- PMPC
- Conditions
- Parastomal Hernia
- Keywords
- Parastomal hernia, Onlay mesh, Sublay mesh, Pain, Health questionnaire
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment from different study sites and due to structural changes in the included centers
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Hvidovre University Hospital, Copenhagen University Hospital at Herlev, Esbjerg Hospital - University Hospital of Southern Denmark, Hillerod Hospital, Denmark, Vejle Hospital, Zealand University Hospital
- Study start
- Mar 2007
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 24 Mar 2008 (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.
Approximately 1/3 of patients with a permanent end-colostomy will experience a hernia around the stoma. In some cases these problems result in the need of surgical correction and the risk of recurrent hernia after operative intervention is regrettably high. Preliminary investigations suggest a role for primary mesh placement to prevent parastomal hernia. The use of a mesh as a preventive measure is a safe procedure. This study will focus on the effect of primary mesh placement (two different operative procedures are used) compared to patients without mesh placement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| onlay mesh | Active comparator | Device: onlay mesh |
| sublay mesh | Active comparator | Device: onlay mesh |
| no mesh | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Permanent end-colostomy after surgery for rectosigmoid cancer with extirpation or Hartmann's procedure.
Key exclusion criteria (7 listed)
- ASA > 3
- Acute surgery
- Known immune deficiency
- Surgery with insertion of foreign body (orthopaedic prosthesis, mechanical or bio-logical heart valve etc.) within the last 3 months.
- Pregnancy
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 |
|---|---|---|
| onlay meshStomaMesh (Precut heavyweight polypropylene mesh) Vypro Mesh (lightweight Prolene and vicryl mesh) | Device | onlay mesh, sublay mesh |
Primary outcome
Parastomal hernia verified by CT-scan
Time frame: one year after surgery, reassessed after 2, 3 and 5 years
3 secondary outcomes
Clinically detected parastomal hernia
Time frame: one year after surgery, reassessed after 2, 3 and 5 years
Pain
Time frame: one year after surgery, reassessed after 2, 3 and 5 years
Disease specific and general health questionnaire
Time frame: one year after surgery, reassessed after 2, 3 and 5 years
Results and safety
The study was stopped early (reason given: Lack of recruitment from different study sites and due to structural changes in the included centers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2014.
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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.
Ismail Gögenur principal investigator
University Hospital of Copenhagen, GEntofte
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing onlay mesh in people with Parastomal Hernia, run by University Hospital, Gentofte, Copenhagen at 2 sites in Denmark.
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 7 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: stopped early, as of the sponsor's last update on 7 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Lack of recruitment from different study sites and due to structural changes in the included centers). Results are not available in the source record.
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 verified by CT-scan (time frame: one year after surgery, reassessed after 2, 3 and 5 years). 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 7 Feb 2014.