Parastomal HerniaPhase 4NCT00509054
Prevention of Parastomal Hernia With a Mesh
A Phase 4 study testing Prophylactic mesh in people with Parastomal Hernia, run by Sundsvall Hospital at 1 site in Sweden.
Trial summary
Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Parastomal Hernia
- What is being tested?
- Prophylactic mesh
- Type of treatment
- Surgery or procedure
- How many people
- 54 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2001to Jul 2007
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical need of an enterostoma
Who cannot join
- Patients denies inclusion in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Clinical Trial of the Use of a Prosthetic Mesh to Prevent Parastomal Hernia
Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position.
Read the detailed description
Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position. Randomisation is by opening closed envelopes.
A low-weight,partly absorbable mesh is used. Patients are followed for 5 years. Clinical follow up after one month to register early complications such as wound infection or mesh infection.
Clinical follow up after 12 months to register parastomal herniation, fistula formation, stenosis.
Clinical follow up after 5 years to register parastomal herniation, fistula formation, stenosis. At this clinical follow up radiologic examination is added.
- Conditions
- Parastomal Hernia
- Being tested
- Prophylactic mesh
- Keywords
- Parastomal hernia, wound infection, stoma care.
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic meshProcedure or surgery
Also called Vypro mesh, Ethicon.
A low weigth partly absorbable mesh in a subaly posistion
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound infection,mesh infection, parastomal hernia.
Measured: Within five years
Secondary outcomes (1)
Fistula formation, stenosis,pain.
Measured: Within five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
- Study startJan 2001
- Primary completionJun 2007
- Study completionJul 2007
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 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sundsvall Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Leif A Israelsson, MD,PhD, Study director, Umea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509054
- Sponsor's protocol ID
- Preventing parastomal hernia
- Status last verified
- Jan 2001
- First submitted
- 30 Jul 2007
- Last updated
- 16 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Janes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh. Arch Surg. 2004 Dec;139(12):1356-8. doi: 10.1001/archsurg.139.12.1356.
PubMed 15613293
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Clinical Trial of the Use of a Prosthetic Mesh to Prevent Parastomal Hernia
- ClinicalTrials.gov ID
- NCT00509054
- Acronym / sponsor ID
- Preventing parastomal hernia
- Conditions
- Parastomal Hernia
- Keywords
- Parastomal hernia, wound infection, stoma care.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Sundsvall HospitalUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 31 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.
Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position.
Detailed description
Parastomal hernias are randomised to either a conventional stoma formed through the rectus anterior muscle or to the same procedure with the addition of a prophylactic mesh in a sublay position. Randomisation is by opening closed envelopes.
A low-weight,partly absorbable mesh is used. Patients are followed for 5 years. Clinical follow up after one month to register early complications such as wound infection or mesh infection.
Clinical follow up after 12 months to register parastomal herniation, fistula formation, stenosis.
Clinical follow up after 5 years to register parastomal herniation, fistula formation, stenosis. At this clinical follow up radiologic examination is added.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical need of an enterostoma
Key exclusion criteria (1 listed)
- Patients denies inclusion in the trial.
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 |
|---|---|---|
| Prophylactic meshAlso: Vypro mesh, Ethicon.A low weigth partly absorbable mesh in a subaly posistion | Procedure or surgery | – |
Primary outcome
Wound infection,mesh infection, parastomal hernia.
Time frame: Within five years
1 secondary outcome
Fistula formation, stenosis,pain.
Time frame: Within five 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 16 Apr 2008.
- Results publication: PubMed 15613293Janes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh. Arch Surg. 2004 Dec;139(12):1356-8. doi: 10.1001/archsurg.139.12.1356.
Related trials for Parastomal Hernia
RecruitingObservational study
Parastomal Hernia at 1 and 3 Years: Radiological Incidence, Progression, and Impact on Quality of Life
Parastomal Hernia, Colorectal Cancer (Diagnosis)
Not yet recruitingObservational study
Improving Decisions and Outcomes in Parastomal Hernia Surgery
Parastomal Hernia
RecruitingObservational study
Risk Factors for Mesh Infection After Abdominal Wall Reconstruction
Incisional Hernia, Ventral Hernia
Recruiting
Comparing the Incidence of Parastomal Hernia After Mesenteric Molding Suturing and Non-molding Suturing in Colostomy Surgery
Parastomal Hernia
Recruiting
Laparoscopic Total Extraperitoneal Plasty as a Modification of Sugabecker's Operation
Parastomal Hernia
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.
Leif A Israelsson, MD,PhD study director
Umea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prophylactic mesh in people with Parastomal Hernia, run by Sundsvall Hospital at 1 site in Sweden.
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 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: finished, as of the sponsor's last update on 16 Apr 2008. 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 Sweden. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Wound infection,mesh infection, parastomal hernia. (time frame: Within five years). 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 NCT00509054, 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 16 Apr 2008; AzTrials last refreshed its copy on 6 Nov 2026.