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Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh (RESEDAE)

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ClinicalTrials.gov Identifier: NCT04282473
Recruitment Status : Recruiting
First Posted : February 24, 2020
Last Update Posted : September 28, 2022
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Study Description
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Brief 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.

Condition or disease
Colostomy Stoma Parastomal Hernia

Study Design
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Study Type : Observational
Estimated Enrollment : 134 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh: Material-epidemiology Study
Actual Study Start Date : May 24, 2022
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Groups and Cohorts
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Group/Cohort
with mesh
Placement of lightweight (<50g/m2) monofilament mesh during colostomy formation
no mesh
colostomy without mesh placement


Outcome Measures
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Primary Outcome Measures :
  1. Rate of parastomal hernia between groups [ Time Frame: 5 years after colostomy formation ]
    Percentage patients with parastomal hernia taken from patient medical records

  2. Date of parastomal hernia [ Time Frame: 5 years after colostomy formation ]
    Date of parastomal hernia taken from patient records


Secondary Outcome Measures :
  1. Protrusion around the stoma [ Time Frame: 5 years after colostomy formation ]
    Yes/no

  2. Patient reported pain [ Time Frame: 5 years after colostomy formation ]
    Yes/no

  3. Occlusion [ Time Frame: 5 years after colostomy formation ]
    Yes/no

  4. Incarceration [ Time Frame: 5 years after colostomy formation ]
    Yes/no

  5. Patient reported quality of life [ Time Frame: 5 years after colostomy formation ]
    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)

  6. Pain at colostomy site [ Time Frame: 5 years after colostomy formation ]
    0-100 scale (no pain to intolerable pain)

  7. Discomfort [ Time Frame: 5 years after colostomy formation ]
    0-100 scale (very uncomfortable to very comfortable)

  8. Patient reported satisfaction [ Time Frame: 5 years after colostomy formation ]
    0-100 scale (not at all satisfied to very satisfied)

  9. Number of specialist and general consultations attended by patients between groups [ Time Frame: 5 years after colostomy formation ]
    number of consultations

  10. Number of medications taken in each group [ Time Frame: 5 years after colostomy formation ]
    Number of medications taken

  11. Other associated treatment received by patients in each group [ Time Frame: 5 years after colostomy formation ]
    number of treatments received

  12. Rehabilitation sessions undergone by patients in each group [ Time Frame: 5 years after colostomy formation ]
    number of rehabilitation sessions

  13. Sick leave taken by patients in each group [ Time Frame: 5 years after colostomy formation ]
    Number of days

  14. Cost of patients care [ Time Frame: 5 years after colostomy formation ]
    Euros


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of patients included in the GRECCAR 07 cohort.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282473


Contacts
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Contact: Michel Prudhomme, MD 06.43.50.35.22 michel.prudhomme@chu-nimes.fr

Locations
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France
L'Hôpital Jean Minjoz Recruiting
Besançon, France
Contact: Zaher Lakkis    03 81 66 71 73    zlakkis@chu-besancon.fr   
Principal Investigator: Zaher Lakkis         
CHU de Bordeaux Not yet recruiting
Bordeaux, France
Contact: Eric Rullier    05 56 79 58 10    eric.rullier@chu-bordeaux.fr   
Principal Investigator: Eric Rullier         
CHRU Clermont- Ferrand Hôtel -Dieu Recruiting
Clermont-Ferrand, France
Contact: Denis Pezet    04 73 75 04 94    dpezet@chu-clermontferrand.fr   
Principal Investigator: Denis Pezet         
Hôpital Beaujon (AP-HP) Not yet recruiting
Clichy, France
Contact: Yves Panis    01 40 87 45 47    yves.panis@bjn.aphp.fr   
Principal Investigator: Yves Panis         
Hôpital Albert Michallon Not yet recruiting
Grenoble, France
Contact: Jean-Luc Faucheron    04 76 76 55 26    JLFaucheron@chu-grenoble.fr   
Principal Investigator: Jean-Luc Faucheron         
Centre Oscar Lambret Recruiting
Lille, France
Contact: Mehrdad Jafari    03 20 29 59 20    m-jafari@o-lambret.fr   
Principal Investigator: Mehrdad Jafari         
Centre Hospitalier Lyon-Sud Recruiting
Lyon, France
Contact: Eddy Cotte    04 78 86 18 01    eddy.cotte@chu-lyon.fr   
Principal Investigator: Eddy Cotte         
Centre Régional de Lutte contre le Cancer Institut Paoli-Calmettes Not yet recruiting
Marseille, France
Contact: Bernard Lelong    04 91 22 37 00    lelongb@ipc.unicancer.fr   
Principal Investigator: Bernard Lelong         
Hôpital La Timone, AP-HM Not yet recruiting
Marseille, France
Contact: Julie Duclos    04 91 38 58 52    julie.duclos@ap-hm.fr   
Principal Investigator: Julie Duclos         
CRLC Val d'Aurelle - Paul Lamarque Not yet recruiting
Montpellier, France
Contact: Philippe Rouanet    04 67 61 31 14    philippe.rouanet@montpellier.unicancer.fr   
Principal Investigator: Philippe Rouanet         
Centre Hospitalier Universitaire Hôtel-Dieu - CHU de Nantes Recruiting
Nantes, France
Contact: Guillaume Meurette    02 40 08 30 22    guillaume.meurette@chu-nantes.fr   
Principal Investigator: Guillaume Meurette         
CHU de Nimes Recruiting
Nîmes, France, 30029
Contact: Anissa Megzari    04.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: Michel Prudhomme         
Hôpital Saint Antoine (AP-HP) Not yet recruiting
Paris, France
Contact: Yann Parc    01 49 28 25 47    yann.parc@sat.aphp.fr   
Principal Investigator: Yann Parc         
Hôpital Pontchaillou Not yet recruiting
Rennes, France
Contact: Bernard Meunier    02 99 28 42 65    bernard.meunier@chu-rennes.fr   
Principal Investigator: Bernard Meunier         
Hôpital Charles-Nicolle Recruiting
Rouen, France
Contact: Jean-Jacques Tuech    02 32 88 85 72    jean-jacques.tuech@univ-rouen.fr   
Principal Investigator: Jean-Jacques Tuech         
Hôpital Purpan - CHU de Toulouse Recruiting
Toulouse, France
Contact: Guillaume Portier    05 61 77 25 30    portier.g@chu-toulouse.fr   
Principal Investigator: Guillaume Portier         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Michel Prudhomme, MD CHU Nimes
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT04282473    
Other Study ID Numbers: NIMAO/2018-02/MP-01
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical