Incisional HerniaNCT00907842
Hernia Prevention in Stomas
A study testing Parietex Parastomal Mesh in people with Incisional Hernia and Parastomal Hernia, run by Marc Schreinemacher at 1 site in Netherlands.
Trial summary
Knowing that the risk of stoma associated herniation (parastomal or incisional) is 30-50% and the associated morbidity significant, standard placement of a prophylactic mesh upon stoma creation might prevent parastomal (or incisional herniation, after closure) and improve the quality of life of a large group of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia, Parastomal Hernia
- What is being tested?
- Parietex Parastomal Mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2010to Apr 2013
- Phase
- Interventional
- 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
- Adult patients with a life expectancy of at least one year
- Temporary stoma formation
- Signed informed consent
- Elective surgery
- Clean-contaminated abdomen
Who cannot join
- American Society of Anaesthesiologists (ASA) score IV or above
- Incapacitated adult or no signed informed consent
- Emergency procedure
- Contaminated or infected abdomen
- Residual intraperitoneal mesh
- Already injured part of the abdominal wall where the stoma will be sited
Show all 10Show fewer
- Contraindication to laparoscopy
- Longterm use of corticosteroids and other immunosuppressive agents
- Current antibiotic therapy
- One of the following conditions: immune deficiency, chemotherapy, ascites, peritoneal dialysis, pregnancy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, 6200 AZ
About this study
Official title: Prevention of Parastomal Hernias and Incisional Hernias in Old Stoma Wounds: a Pilot Study
Knowing that the risk of stoma associated herniation (parastomal or incisional) is 30-50% and the associated morbidity significant, standard placement of a prophylactic mesh upon stoma creation might prevent parastomal (or incisional herniation, after closure) and improve the quality of life of a large group of patients. This study is meant to be a pilot study to see whether the mesh related risks of infection and adhesion morbidity are acceptable if the mesh is placed intraperitoneally.
Read the detailed description
The idea of a prophylactic mesh has been tested before in a Swedish randomized controlled trial (RCT) with the mesh placed upon end colostomy formation. Results suggest this procedure is the panacea against stoma associated herniations. The investigators still have unanswered questions however, about the size and ideal position of the mesh, possible complications (infection, adhesions) and the benefit in terms of quality of life.
- Conditions
- Incisional Hernia, Parastomal Hernia
- Being tested
- Parietex Parastomal Mesh
- Keywords
- stoma
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parietex Parastomal MeshDevice
mesh placed intraperitoneally around the stoma
| Study group | Role | What they receive |
|---|---|---|
| mesh placement | Experimental | Not described Receives: Device: Parietex Parastomal Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications after prophylactic mesh placement around a stoma (i.e., infection of the mesh and adhesions to the mesh)
Measured: one year after placement
incisional herniation at the old stoma wound
Measured: two years
Secondary outcomes (1)
stoma complications (stenosis, bulging, prolapse, retraction, skin problems)
Measured: two years after placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study startApr 2010
- Primary completionFeb 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Incisional 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marc Schreinemacher
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marc Schreinemacher, Academisch Ziekenhuis Maastricht
- Investigators
- Nicole Bouvy, MD, PhD, Study director, Maastricht University Medical CentreMarc Schreinemacher, MD, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907842
- Sponsor's protocol ID
- MEC09-2-052
- Other IDs
- NL27625.068.09
- Status last verified
- Apr 2013
- First submitted
- 21 May 2009
- Last updated
- 8 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Janes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh: a 5-year follow-up of a randomized study. World J Surg. 2009 Jan;33(1):118-21; discussion 122-3. doi: 10.1007/s00268-008-9785-4.
PubMed 19011935Cingi A, Cakir T, Sever A, Aktan AO. Enterostomy site hernias: a clinical and computerized tomographic evaluation. Dis Colon Rectum. 2006 Oct;49(10):1559-63. doi: 10.1007/s10350-006-0681-4.
PubMed 17120189
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Parastomal Hernias and Incisional Hernias in Old Stoma Wounds: a Pilot Study
- ClinicalTrials.gov ID
- NCT00907842
- Acronym / sponsor ID
- MEC09-2-052
- Conditions
- Incisional Hernia, Parastomal Hernia
- Keywords
- stoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Marc SchreinemacherUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 25 May 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.
Knowing that the risk of stoma associated herniation (parastomal or incisional) is 30-50% and the associated morbidity significant, standard placement of a prophylactic mesh upon stoma creation might prevent parastomal (or incisional herniation, after closure) and improve the quality of life of a large group of patients. This study is meant to be a pilot study to see whether the mesh related risks of infection and adhesion morbidity are acceptable if the mesh is placed intraperitoneally.
Detailed description
The idea of a prophylactic mesh has been tested before in a Swedish randomized controlled trial (RCT) with the mesh placed upon end colostomy formation. Results suggest this procedure is the panacea against stoma associated herniations. The investigators still have unanswered questions however, about the size and ideal position of the mesh, possible complications (infection, adhesions) and the benefit in terms of quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mesh placement | Experimental | Device: Parietex Parastomal Mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients with a life expectancy of at least one year
- Temporary stoma formation
- Signed informed consent
- Elective surgery
- Clean-contaminated abdomen
Key exclusion criteria (10 listed)
- American Society of Anaesthesiologists (ASA) score IV or above
- Incapacitated adult or no signed informed consent
- Emergency procedure
- Contaminated or infected abdomen
- Residual intraperitoneal mesh
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 |
|---|---|---|
| Parietex Parastomal Meshmesh placed intraperitoneally around the stoma | Device | mesh placement |
Primary outcome
postoperative complications after prophylactic mesh placement around a stoma (i.e., infection of the mesh and adhesions to the mesh)
Time frame: one year after placement
incisional herniation at the old stoma wound
Time frame: two years
1 secondary outcome
stoma complications (stenosis, bulging, prolapse, retraction, skin problems)
Time frame: two years after placement
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 8 Apr 2013.
- Background: PubMed 19011935Janes A, Cengiz Y, Israelsson LA. Preventing parastomal hernia with a prosthetic mesh: a 5-year follow-up of a randomized study. World J Surg. 2009 Jan;33(1):118-21; discussion 122-3. doi: 10.1007/s00268-008-9785-4.
- Background: PubMed 17120189Cingi A, Cakir T, Sever A, Aktan AO. Enterostomy site hernias: a clinical and computerized tomographic evaluation. Dis Colon Rectum. 2006 Oct;49(10):1559-63. doi: 10.1007/s10350-006-0681-4.
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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.
Nicole Bouvy, MD, PhD study director
Maastricht University Medical Centre
Marc Schreinemacher, MD principal investigator
Maastricht University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parietex Parastomal Mesh in people with Incisional Hernia and Parastomal Hernia, run by Marc Schreinemacher at 1 site in Netherlands.
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 5 inclusion and 10 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 8 Apr 2013. 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 Netherlands. 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?
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?
postoperative complications after prophylactic mesh placement around a stoma (i.e., infection of the mesh and adhesions to the mesh) (time frame: one year after placement). The study lists 2 primary outcomes in all. 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 NCT00907842, which also lists 2 linked publications.
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 8 Apr 2013.