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

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

Tracking Information

• First Submitted Date: February 21, 2020
• First Posted Date: February 24, 2020
• Last Update Posted Date: September 28, 2022
• Actual Study Start Date: May 24, 2022
• Estimated Primary Completion Date: May 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 21, 2020)

• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 21, 2020)

• Protrusion around the stoma [ Time Frame: 5 years after colostomy formation ]
  Yes/no
• Patient reported pain [ Time Frame: 5 years after colostomy formation ]
  Yes/no
• Occlusion [ Time Frame: 5 years after colostomy formation ]
  Yes/no
• Incarceration [ Time Frame: 5 years after colostomy formation ]
  Yes/no
• 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)
• Pain at colostomy site [ Time Frame: 5 years after colostomy formation ]
  0-100 scale (no pain to intolerable pain)
• Discomfort [ Time Frame: 5 years after colostomy formation ]
  0-100 scale (very uncomfortable to very comfortable)
• Patient reported satisfaction [ Time Frame: 5 years after colostomy formation ]
  0-100 scale (not at all satisfied to very satisfied)
• Number of specialist and general consultations attended by patients between groups [ Time Frame: 5 years after colostomy formation ]
  number of consultations
• Number of medications taken in each group [ Time Frame: 5 years after colostomy formation ]
  Number of medications taken
• Other associated treatment received by patients in each group [ Time Frame: 5 years after colostomy formation ]
  number of treatments received
• Rehabilitation sessions undergone by patients in each group [ Time Frame: 5 years after colostomy formation ]
  number of rehabilitation sessions
• Sick leave taken by patients in each group [ Time Frame: 5 years after colostomy formation ]
  Number of days
• Cost of patients care [ Time Frame: 5 years after colostomy formation ]
  Euros

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: The study population consists of patients included in the GRECCAR 07 cohort.

Condition

• Colostomy Stoma
• Parastomal Hernia

• Intervention: Not Provided

Study Groups/Cohorts

• with mesh
  Placement of lightweight (<50g/m2) monofilament mesh during colostomy formation
• no mesh
  colostomy without mesh placement

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 21, 2020): 134
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2024
• Estimated Primary Completion Date: May 2023 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04282473
• Other Study ID Numbers: NIMAO/2018-02/MP-01
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Centre Hospitalier Universitaire de Nīmes
• Original Responsible Party: Same as current
• Current Study Sponsor: Centre Hospitalier Universitaire de Nīmes
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Michel Prudhomme, MD; CHU Nimes

• PRS Account: Centre Hospitalier Universitaire de Nīmes
• Verification Date: February 2022