Parastomal HerniaPhase 2/3STOMAMESHNCT00917995
Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh
A Phase 2/3 study testing Polypropylene Mesh, density 25-40g/square meter in people with Parastomal Hernia, run by Norrbottens Lans Landsting at 1 site in Sweden.
Trial summary
Specific aim: To compare patients with colostomies with or without mesh at the primary operation. Primary endpoint is the incidence of parastomal hernia requiring surgery. All patients at participating centers scheduled for permanent colostomy, after signing informed consent and meeting inclusion criteria, will be… 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?
- Polypropylene Mesh, density 25-40g/square meter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2008to Sep 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
- Patient is scheduled for permanent colostomy elective or acute operation. The optimal site for stoma is marked preoperatively.
- No previous stoma.
- Over the age of 18.
- Informed consent signed by the patient.
Who cannot join
- Expected lifetime less then 3 years.
- Fecal peritonitis (perforated bowel with free intestinal content in the peritoneal cavity).
- Previous stoma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: STOMAMESH Prospective Randomised Multicenter Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh
Specific aim:
To compare patients with colostomies with or without mesh at the primary operation. Primary endpoint is the incidence of parastomal hernia requiring surgery.
All patients at participating centers scheduled for permanent colostomy, after signing informed consent and meeting inclusion criteria, will be randomised to formation of a stoma with or without mesh.
If the inclusion criteria is fulfilled and informed consent is signed, the patient is randomised preoperatively.
Read the detailed description
Parastomal hernia is a relatively common and troublesome complication in patients with a stoma. The exact incidence is not known and depending on definitions and if a bulging is a hernia or not, as well as when after the operation the examination is performed, the incidence varies between 0-48%. A parastomal hernia may give the patient difficulties with appliance and leakage. From an economical point of view a stoma that requires special kinds of appliances is expensive. Theoretically, strengthening of the abdominal wall with a mesh at the the primary operation would reduce the risk for parastomal hernia. Recently presented data suggest that a mesh at the primary operation really does reduce the risk to develop a parastomal hernia. No negative side effects with the use of a mesh have been reported in these studies. All earlier studies have involved relatively small numbers of patients and short times of observation, and therefore under-dimensioned concerning potential negative late side-effects. Complications seen in other studies where mesh has been used in surgery of the bowel include fistulas and infections among others. To understand if mesh at the primary operation, in a safe way, reduces the risk for developing parastomal hernia compared to conventional surgery, is important to perform this new prospective randomised multicenter trial.
Specific aim:
To compare patients with colostomies with or without mesh at the primary operation. Primary endpoint is the incidence of parastomal hernia requiring surgery.
All patients at participating centers scheduled for permanent colostomy, after signing informed consent and meeting inclusion criteria, will be randomised to formation of a stoma with or without mesh.
If the inclusion criteria is fulfilled and informed consent is signed, the patient is randomised preoperatively.
- Conditions
- Parastomal Hernia
- Being tested
- Polypropylene Mesh, density 25-40g/square meter
- Keywords
- parastomal hernia, prophylactic mesh, colostomy, hernia
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polypropylene Mesh, density 25-40g/square meterDevice
colostomy with a prophylactic hernia mesh
| Study group | Role | What they receive |
|---|---|---|
| Colostomy with a prophylactic mesh | Experimental | Not described Receives: Device: Polypropylene Mesh, density 25-40g/square meter |
| Colostomy without a prophylactic mesh | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of parastomal hernias in the two groups at 12 and 36 months postoperatively
Measured: At 12 and 36 months postoperatively
Secondary outcomes (4)
Quality of life related to health
Measured: At 12 and 36 months postoperatively
The health care systems total cost related to the stoma
Measured: At 12 and 36 months postoperatively
Rate of infections 30 days postoperatively
Measured: At 30 days postoperatively
Late complication related to the mesh leading to surgery
Measured: At 12 and 36 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startJan 2008
- Primary completionSep 2015
- Study completionSep 2015
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norrbottens Lans Landsting
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pia Nasvall, Norrbottens Lans Landsting
- Investigators
- Michael Dahlberg, MD PhD, Study chair, Dept of Surgery Sunderby Hospital, Luela, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917995
- Sponsor's protocol ID
- 07-081M
- Acronym
- STOMAMESH
- Status last verified
- Oct 2015
- First submitted
- 8 Jun 2009
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Naverlo S, Gunnarsson U, Strigard K, Nasvall P. Quality of life after end colostomy without mesh and with prophylactic synthetic mesh in sublay position: one-year results of the STOMAMESH trial. Int J Colorectal Dis. 2019 Sep;34(9):1591-1599. doi: 10.1007/s00384-019-03359-2. Epub 2019 Aug 7.
PubMed 31392405
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STOMAMESH Prospective Randomised Multicenter Trial Concerning the Frequency of Parastomal Hernia With or Without a Mesh
- ClinicalTrials.gov ID
- NCT00917995
- Acronym / sponsor ID
- STOMAMESH / 07-081M
- Conditions
- Parastomal Hernia
- Keywords
- parastomal hernia, prophylactic mesh, colostomy, hernia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Norrbottens Lans LandstingUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 11 Jun 2009 (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.
Specific aim:
To compare patients with colostomies with or without mesh at the primary operation. Primary endpoint is the incidence of parastomal hernia requiring surgery.
All patients at participating centers scheduled for permanent colostomy, after signing informed consent and meeting inclusion criteria, will be randomised to formation of a stoma with or without mesh.
If the inclusion criteria is fulfilled and informed consent is signed, the patient is randomised preoperatively.
Detailed description
Parastomal hernia is a relatively common and troublesome complication in patients with a stoma. The exact incidence is not known and depending on definitions and if a bulging is a hernia or not, as well as when after the operation the examination is performed, the incidence varies between 0-48%. A parastomal hernia may give the patient difficulties with appliance and leakage. From an economical point of view a stoma that requires special kinds of appliances is expensive. Theoretically, strengthening of the abdominal wall with a mesh at the the primary operation would reduce the risk for parastomal hernia. Recently presented data suggest that a mesh at the primary operation really does reduce the risk to develop a parastomal hernia. No negative side effects with the use of a mesh have been reported in these studies. All earlier studies have involved relatively small numbers of patients and short times of observation, and therefore under-dimensioned concerning potential negative late side-effects. Complications seen in other studies where mesh has been used in surgery of the bowel include fistulas and infections among others. To understand if mesh at the primary operation, in a safe way, reduces the risk for developing parastomal hernia compared to conventional surgery, is important to perform this new prospective randomised multicenter trial.
Specific aim:
To compare patients with colostomies with or without mesh at the primary operation. Primary endpoint is the incidence of parastomal hernia requiring surgery.
All patients at participating centers scheduled for permanent colostomy, after signing informed consent and meeting inclusion criteria, will be randomised to formation of a stoma with or without mesh.
If the inclusion criteria is fulfilled and informed consent is signed, the patient is randomised preoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colostomy with a prophylactic mesh | Experimental | Device: Polypropylene Mesh, density 25-40g/square meter |
| Colostomy without a prophylactic 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 (4 listed)
- Patient is scheduled for permanent colostomy elective or acute operation. The optimal site for stoma is marked preoperatively.
- No previous stoma.
- Over the age of 18.
- Informed consent signed by the patient.
Key exclusion criteria (3 listed)
- Expected lifetime less then 3 years.
- Fecal peritonitis (perforated bowel with free intestinal content in the peritoneal cavity).
- Previous stoma.
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 |
|---|---|---|
| Polypropylene Mesh, density 25-40g/square metercolostomy with a prophylactic hernia mesh | Device | Colostomy with a prophylactic mesh |
Primary outcome
The number of parastomal hernias in the two groups at 12 and 36 months postoperatively
Time frame: At 12 and 36 months postoperatively
4 secondary outcomes
Quality of life related to health
Time frame: At 12 and 36 months postoperatively
The health care systems total cost related to the stoma
Time frame: At 12 and 36 months postoperatively
Rate of infections 30 days postoperatively
Time frame: At 30 days postoperatively
Late complication related to the mesh leading to surgery
Time frame: At 12 and 36 months postoperatively
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 Oct 2015.
- Derived from this study: PubMed 31392405Naverlo S, Gunnarsson U, Strigard K, Nasvall P. Quality of life after end colostomy without mesh and with prophylactic synthetic mesh in sublay position: one-year results of the STOMAMESH trial. Int J Colorectal Dis. 2019 Sep;34(9):1591-1599. doi: 10.1007/s00384-019-03359-2. Epub 2019 Aug 7.
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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.
Michael Dahlberg, MD PhD study chair
Dept of Surgery Sunderby Hospital, Luela, Sweden
1 site 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 Polypropylene Mesh, density 25-40g/square meter in people with Parastomal Hernia, run by Norrbottens Lans Landsting 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 4 inclusion and 3 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 Oct 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 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 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 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?
The number of parastomal hernias in the two groups at 12 and 36 months postoperatively (time frame: At 12 and 36 months postoperatively). 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 NCT00917995, 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 Oct 2015.