Incisional Hernia After Diverting Stoma ClosureMEMBONCT02576184
Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery
A study testing Biologic Mesh and Synthetic Mesh in people with Incisional Hernia After Diverting Stoma Closure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after total mesorectal excision (TME) for rectal cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia After Diverting Stoma Closure
- What is being tested?
- Biologic Mesh and Synthetic Mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to 15 Nov 2020
- 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
- Age > 18
- Operated on for diverting ileostoma closure after sphincter saving rectal cancer surgery, irrespective of the time delay between ileostoma closure and rectal cancer surgery
- Signed consent
- Affiliation to the French social security system
Who cannot join
- Emergency surgery
- History of laparotomy before ileostoma closure.
- Surgery associated to the ileostoma closure, excluding appendectomy or liver biopsy
- Lactating or pregnant woman
- Allergy to porcine product or collagen-based product. Allergy to polypropylene.
- Participation to another protocol focusing on ileostoma closure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery: A Randomized-controlled Trial
This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after total mesorectal excision (TME) for rectal cancer
Read the detailed description
This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after TME for rectal cancer.
Patients are randomized in 3 groups : no mesh, synthetic mesh (Parietex, Covidien), biologic mesh (Cellis, Meccelis). Meshes are placed in retromuscular position after diverting ileostomy closure.
Primary endpoint is radiological incisional hernia rate, assessed on CT-scan, at the end of follow-up Secondary endpoints include postoperative morbidity, postoperative pain, postoperative quality of life, long-term clinical incisional hernia rate.
- Being tested
- Biologic Mesh, Synthetic Mesh
- Keywords
- Incisional hernia, Stoma, rectal cancer, synthetic mesh, biologic mesh
- Medical subject headings
- Incisional Hernia, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic MeshDevice
Biologic mesh placed in retromuscular position during ileostoma closure
Synthetic MeshDevice
synthetic mesh placed in retromuscular position during ileostoma closure
| Study group | Role | What they receive |
|---|---|---|
| Biologic Mesh | Experimental | Biologic mesh placed in retromuscular position Receives: Device: Biologic Mesh |
| Synthetic Mesh | Experimental | Synthetic mesh placed in retromuscular position Receives: Device: Synthetic Mesh |
| No Mesh | No intervention | No mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiological incisional hernia rate
Primary endpoint is radiological incisional hernia rate, assessed on CT-scan, at the end of follow-up.
Statistical analysis will be performed as soon as follow-up reach 12 months for last included patient
Measured: up to 36 months
Secondary outcomes (6)
Postoperative morbidity
Postoperative morbidity
Measured: 30 days
Postoperative pain
Score Brief Pain Inventory
Measured: 36 months
Postoperative rehospitalization
Case report form data
Measured: 36 months
Postoperative reintervention
Case report form data
Measured: 36 months
Quality of life (The Short Form (36) Health Survey score)
The Short Form (36) Health Survey
Measured: 12 months
Clinical incisional hernia rate
Clinical incisional hernia rate : Statistical analysis will be performed as soon as follow-up reach 12 months for last included patient
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startDec 2015
- Primary completion15 Nov 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional Hernia After Diverting Stoma ClosureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Biologic mesh Synthetic mesh
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leon Maggiori, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576184
- Sponsor's protocol ID
- P140312
- Other IDs
- 2015-A00410-49
- Acronym
- MEMBO
- Status last verified
- Nov 2021
- First submitted
- 5 Oct 2015
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery: A Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT02576184
- Acronym / sponsor ID
- MEMBO / P140312
- Keywords
- Incisional hernia, Stoma, rectal cancer, synthetic mesh, biologic mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 15 Oct 2015 (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.
This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after total mesorectal excision (TME) for rectal cancer
Detailed description
This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after TME for rectal cancer.
Patients are randomized in 3 groups : no mesh, synthetic mesh (Parietex, Covidien), biologic mesh (Cellis, Meccelis). Meshes are placed in retromuscular position after diverting ileostomy closure.
Primary endpoint is radiological incisional hernia rate, assessed on CT-scan, at the end of follow-up Secondary endpoints include postoperative morbidity, postoperative pain, postoperative quality of life, long-term clinical incisional hernia rate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Biologic mesh Synthetic mesh
| Arm | Type | Receives |
|---|---|---|
| Biologic Mesh | Experimental | Device: Biologic MeshBiologic mesh placed in retromuscular position |
| Synthetic Mesh | Experimental | Device: Synthetic MeshSynthetic mesh placed in retromuscular position |
| No Mesh | No intervention | –No mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18
- Operated on for diverting ileostoma closure after sphincter saving rectal cancer surgery, irrespective of the time delay between ileostoma closure and rectal cancer surgery
- Signed consent
- Affiliation to the French social security system
Key exclusion criteria (6 listed)
- Emergency surgery
- History of laparotomy before ileostoma closure.
- Surgery associated to the ileostoma closure, excluding appendectomy or liver biopsy
- Lactating or pregnant woman
- Allergy to porcine product or collagen-based product. Allergy to polypropylene.
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 |
|---|---|---|
| Biologic MeshBiologic mesh placed in retromuscular position during ileostoma closure | Device | Biologic Mesh |
| Synthetic Meshsynthetic mesh placed in retromuscular position during ileostoma closure | Device | Synthetic Mesh |
Primary outcome
radiological incisional hernia rate
Time frame: up to 36 months
Primary endpoint is radiological incisional hernia rate, assessed on CT-scan, at the end of follow-up. Statistical analysis will be performed as soon as follow-up reach 12 months for last included patient
6 secondary outcomes
Postoperative morbidity
Time frame: 30 days
Postoperative pain
Time frame: 36 months
Postoperative rehospitalization
Time frame: 36 months
Postoperative reintervention
Time frame: 36 months
Quality of life (The Short Form (36) Health Survey score)
Time frame: 12 months
Clinical incisional hernia rate
Time frame: 36 months
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 22 Nov 2021.
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.
Leon Maggiori, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biologic Mesh and Synthetic Mesh in people with Incisional Hernia After Diverting Stoma Closure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 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 22 Nov 2021. 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 France. 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?
radiological incisional hernia rate (time frame: up to 36 months). 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 22 Nov 2021; AzTrials last refreshed its copy on 30 Oct 2026.