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Studies

Observational Recruiting

NCT04282473 on ClinicalTrials.gov

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

Official title: Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh: Material-epidemiology Study

  • Sponsor: Centre Hospitalier Universitaire de Nîmes
  • Enrollment: 134 (Estimated)
  • Study start: 2022-05-24 (Actual)
  • Primary completion: 2025-05-01 (Estimated)
  • Study completion: 2026-05-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

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.

Conditions

  • Colostomy Stoma
  • Parastomal Hernia

Primary Outcome Measures

  • Rate of parastomal hernia between groups (5 years after colostomy formation)
    Percentage patients with parastomal hernia taken from patient medical records
  • Date of parastomal hernia (5 years after colostomy formation)
    Date of parastomal hernia taken from patient records

Countries

France

Locations and Investigators

  • L'Hôpital Jean Minjoz, Besançon, France (Recruiting)
  • CHU de Bordeaux, Bordeaux, France (Not yet recruiting)
    • Eric Rullier
    • Eric Rullier (Principal Investigator)
  • CHRU Clermont- Ferrand Hôtel -Dieu, Clermont-Ferrand, France (Recruiting)
  • Hôpital Beaujon (AP-HP), Clichy, France (Not yet recruiting)
  • Hôpital Albert Michallon, Grenoble, France (Not yet recruiting)
  • Centre Oscar Lambret, Lille, France (Recruiting)
    • Mehrdad Jafari
    • Mehrdad Jafari (Principal Investigator)
  • Centre Hospitalier Lyon-Sud, Lyon, France (Recruiting)
  • Centre Régional de Lutte contre le Cancer Institut Paoli-Calmettes, Marseille, France (Not yet recruiting)
    • Bernard Lelong
    • Bernard Lelong (Principal Investigator)
  • Hôpital La Timone, AP-HM, Marseille, France (Not yet recruiting)
    • Julie Duclos
    • Julie Duclos (Principal Investigator)
  • CRLC Val d'Aurelle - Paul Lamarque, Montpellier, France (Not yet recruiting)
  • Centre Hospitalier Universitaire Hôtel-Dieu - CHU de Nantes, Nantes, France (Recruiting)
    • Guillaume Meurette
    • Guillaume Meurette (Principal Investigator)
  • CHU de Nimes, Nîmes, France (Recruiting)
    • Anissa Megzari
    • Michel Prudhomme (Principal Investigator)
  • Hôpital Saint Antoine (AP-HP), Paris, France (Not yet recruiting)
    • Yann Parc
    • Yann Parc (Principal Investigator)
  • Hôpital Pontchaillou, Rennes, France (Not yet recruiting)
    • Bernard Meunier
    • Bernard Meunier (Principal Investigator)
  • Hôpital Charles-Nicolle, Rouen, France (Recruiting)
  • Hôpital Purpan - CHU de Toulouse, Toulouse, France (Recruiting)
    • Guillaume Portier
    • Guillaume Portier (Principal Investigator)

Study Officials

  • Michel Prudhomme, MD (Principal Investigator) — CHU Nimes