Colostomy StomaRESEDAENCT04282473
Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh
An observational study of Colostomy Stoma and Parastomal Hernia, run by Centre Hospitalier Universitaire de Nīmes at 16 sites in France.
Trial summary
This study is a follow-up of the GRECCAR 07 cohort (NCT01380860). Patients will be evaluated 5 years following terminal colostomy to observe patient long-term patient outcomes from colostomy with and without mesh placement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colostomy Stoma, Parastomal Hernia
- How many people
- 134 participants
- Where
- 16 sitesFrance
- Study dates
- 24 May 2022to May 2026
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The study population consists of patients included in the GRECCAR 07 cohort.
Who may be able to join
- The patient must be affiliated with a health insurance programme
- Patient was included in the GRECCAR 07 cohort (PHRC National 2011; N° RCB: 2011-A01572-39 - ClinicalTrials.gov ID: NCT01380860)
- Patient received colostomy 5 years ago
Who cannot join
- The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
- The subject signals opposition to participating in the study
- The patient is under safeguard of justice or state guardianship
- The patient is pregnant or breastfeeding
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites, 16 recruiting
- Recruiting
L'Hôpital Jean Minjoz
Besançon
Zaher Lakkis, 03 81 66 71 73, zlakkis@chu-besancon.fr
Zaher Lakkis
- Not yet recruiting
CHU de Bordeaux
Bordeaux
Eric Rullier, 05 56 79 58 10, eric.rullier@chu-bordeaux.fr
Eric Rullier
- Recruiting
CHRU Clermont- Ferrand Hôtel -Dieu
Clermont-Ferrand
Denis Pezet, 04 73 75 04 94, dpezet@chu-clermontferrand.fr
Denis Pezet
- Not yet recruiting
Hôpital Beaujon (AP-HP)
Clichy
Yves Panis, 01 40 87 45 47, yves.panis@bjn.aphp.fr
Yves Panis
- Not yet recruiting
Hôpital Albert Michallon
Grenoble
Jean-Luc Faucheron, 04 76 76 55 26, JLFaucheron@chu-grenoble.fr
Jean-Luc Faucheron
- Recruiting
Centre Oscar Lambret
Lille
Mehrdad Jafari, 03 20 29 59 20, m-jafari@o-lambret.fr
Mehrdad Jafari
- Recruiting
Centre Hospitalier Lyon-Sud
Lyon
Eddy Cotte, 04 78 86 18 01, eddy.cotte@chu-lyon.fr
Eddy Cotte
- Not yet recruiting
Centre Régional de Lutte contre le Cancer Institut Paoli-Calmettes
Marseille
Bernard Lelong, 04 91 22 37 00, lelongb@ipc.unicancer.fr
Bernard Lelong
- Not yet recruiting
Hôpital La Timone, AP-HM
Marseille
Julie Duclos, 04 91 38 58 52, julie.duclos@ap-hm.fr
Julie Duclos
- Not yet recruiting
CRLC Val d'Aurelle - Paul Lamarque
Montpellier
Philippe Rouanet, 04 67 61 31 14, philippe.rouanet@montpellier.unicancer.fr
Philippe Rouanet
- Recruiting
Centre Hospitalier Universitaire Hôtel-Dieu - CHU de Nantes
Nantes
Guillaume Meurette, 02 40 08 30 22, guillaume.meurette@chu-nantes.fr
Guillaume Meurette
- Recruiting
CHU de Nimes
Nîmes, 30029
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Michel Prudhomme
- Not yet recruiting
Hôpital Saint Antoine (AP-HP)
Paris
Yann Parc, 01 49 28 25 47, yann.parc@sat.aphp.fr
Yann Parc
- Not yet recruiting
Hôpital Pontchaillou
Rennes
Bernard Meunier, 02 99 28 42 65, bernard.meunier@chu-rennes.fr
Bernard Meunier
- Recruiting
Hôpital Charles-Nicolle
Rouen
Jean-Jacques Tuech, 02 32 88 85 72, jean-jacques.tuech@univ-rouen.fr
Jean-Jacques Tuech
- Recruiting
Hôpital Purpan - CHU de Toulouse
Toulouse
Guillaume Portier, 05 61 77 25 30, portier.g@chu-toulouse.fr
Guillaume Portier
About this study
Official title: Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh: Material-epidemiology Study
This study is a follow-up of the GRECCAR 07 cohort (NCT01380860). Patients will be evaluated 5 years following terminal colostomy to observe patient long-term patient outcomes from colostomy with and without mesh placement.
- Conditions
- Colostomy Stoma, Parastomal Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| with mesh | Placement of lightweight (<50g/m2) monofilament mesh during colostomy formation | |
| no mesh | colostomy without mesh placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of parastomal hernia between groups
Percentage patients with parastomal hernia taken from patient medical records
Measured: 5 years after colostomy formation
Date of parastomal hernia
Date of parastomal hernia taken from patient records
Measured: 5 years after colostomy formation
Secondary outcomes (14)
Protrusion around the stoma
Yes/no
Measured: 5 years after colostomy formation
Patient reported pain
Yes/no
Measured: 5 years after colostomy formation
Occlusion
Yes/no
Measured: 5 years after colostomy formation
Incarceration
Yes/no
Measured: 5 years after colostomy formation
Patient reported quality of life
Stoma-QoL questionnaire - a 20-item questionnaire on a four-point Likert scale with total score ranging from 0 (worst score) to 100 (best score)
Measured: 5 years after colostomy formation
Pain at colostomy site
0-100 scale (no pain to intolerable pain)
Measured: 5 years after colostomy formation
Discomfort
0-100 scale (very uncomfortable to very comfortable)
Measured: 5 years after colostomy formation
Patient reported satisfaction
0-100 scale (not at all satisfied to very satisfied)
Measured: 5 years after colostomy formation
Number of specialist and general consultations attended by patients between groups
number of consultations
Measured: 5 years after colostomy formation
Number of medications taken in each group
Number of medications taken
Measured: 5 years after colostomy formation
Other associated treatment received by patients in each group
number of treatments received
Measured: 5 years after colostomy formation
Rehabilitation sessions undergone by patients in each group
number of rehabilitation sessions
Measured: 5 years after colostomy formation
Sick leave taken by patients in each group
Number of days
Measured: 5 years after colostomy formation
Cost of patients care
Euros
Measured: 5 years after colostomy formation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start24 May 2022
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colostomy StomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Prudhomme, MD, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282473
- Sponsor's protocol ID
- NIMAO/2018-02/MP-01
- Acronym
- RESEDAE
- Status last verified
- Jun 2024
- First submitted
- 21 Feb 2020
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh: Material-epidemiology Study
- ClinicalTrials.gov ID
- NCT04282473
- Acronym / sponsor ID
- RESEDAE / NIMAO/2018-02/MP-01
- Conditions
- Colostomy Stoma, Parastomal Hernia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 24 Feb 2020 (actual)
- 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 is a follow-up of the GRECCAR 07 cohort (NCT01380860). Patients will be evaluated 5 years following terminal colostomy to observe patient long-term patient outcomes from colostomy with and without mesh placement.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with mesh | – | –Placement of lightweight (<50g/m2) monofilament mesh during colostomy formation |
| no mesh | – | –colostomy without mesh placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients included in the GRECCAR 07 cohort.
Key inclusion criteria (3 listed)
- The patient must be affiliated with a health insurance programme
- Patient was included in the GRECCAR 07 cohort (PHRC National 2011; N° RCB: 2011-A01572-39 - ClinicalTrials.gov ID: NCT01380860)
- Patient received colostomy 5 years ago
Key exclusion criteria (4 listed)
- The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
- The subject signals opposition to participating in the study
- The patient is under safeguard of justice or state guardianship
- The patient is pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of parastomal hernia between groups
Time frame: 5 years after colostomy formation
Percentage patients with parastomal hernia taken from patient medical records
Date of parastomal hernia
Time frame: 5 years after colostomy formation
Date of parastomal hernia taken from patient records
14 secondary outcomes
Protrusion around the stoma
Time frame: 5 years after colostomy formation
Patient reported pain
Time frame: 5 years after colostomy formation
Occlusion
Time frame: 5 years after colostomy formation
Incarceration
Time frame: 5 years after colostomy formation
Patient reported quality of life
Time frame: 5 years after colostomy formation
Pain at colostomy site
Time frame: 5 years after colostomy formation
Discomfort
Time frame: 5 years after colostomy formation
Patient reported satisfaction
Time frame: 5 years after colostomy formation
Number of specialist and general consultations attended by patients between groups
Time frame: 5 years after colostomy formation
Number of medications taken in each group
Time frame: 5 years after colostomy formation
Other associated treatment received by patients in each group
Time frame: 5 years after colostomy formation
Rehabilitation sessions undergone by patients in each group
Time frame: 5 years after colostomy formation
Sick leave taken by patients in each group
Time frame: 5 years after colostomy formation
Cost of patients care
Time frame: 5 years after colostomy formation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
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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.
Michel Prudhomme, MD principal investigator
CHU Nimes
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colostomy Stoma and Parastomal Hernia, run by Centre Hospitalier Universitaire de Nīmes at 16 sites 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel Prudhomme, MD (06.43.50.35.22, michel.prudhomme@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of parastomal hernia between groups (time frame: 5 years after colostomy formation). 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?
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 25 Jun 2024.