RESEDAE: Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| with mesh Placement of lightweight (<50g/m2) monofilament mesh during colostomy formation |
|
| no mesh colostomy without mesh placement |
Outcome Measures
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
Secondary Outcome Measures
- Protrusion around the stoma [5 years after colostomy formation]
Yes/no
- Patient reported pain [5 years after colostomy formation]
Yes/no
- Occlusion [5 years after colostomy formation]
Yes/no
- Incarceration [5 years after colostomy formation]
Yes/no
- Patient reported quality of life [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 [5 years after colostomy formation]
0-100 scale (no pain to intolerable pain)
- Discomfort [5 years after colostomy formation]
0-100 scale (very uncomfortable to very comfortable)
- Patient reported satisfaction [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 [5 years after colostomy formation]
number of consultations
- Number of medications taken in each group [5 years after colostomy formation]
Number of medications taken
- Other associated treatment received by patients in each group [5 years after colostomy formation]
number of treatments received
- Rehabilitation sessions undergone by patients in each group [5 years after colostomy formation]
number of rehabilitation sessions
- Sick leave taken by patients in each group [5 years after colostomy formation]
Number of days
- Cost of patients care [5 years after colostomy formation]
Euros
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | L'Hôpital Jean Minjoz | Besançon | France | ||
| 2 | CHU de Bordeaux | Bordeaux | France | ||
| 3 | CHRU Clermont- Ferrand Hôtel -Dieu | Clermont-Ferrand | France | ||
| 4 | Hôpital Beaujon (AP-HP) | Clichy | France | ||
| 5 | Hôpital Albert Michallon | Grenoble | France | ||
| 6 | Centre Oscar Lambret | Lille | France | ||
| 7 | Centre Hospitalier Lyon-Sud | Lyon | France | ||
| 8 | Centre Régional de Lutte contre le Cancer Institut Paoli-Calmettes | Marseille | France | ||
| 9 | Hôpital La Timone, AP-HM | Marseille | France | ||
| 10 | CRLC Val d'Aurelle - Paul Lamarque | Montpellier | France | ||
| 11 | Centre Hospitalier Universitaire Hôtel-Dieu - CHU de Nantes | Nantes | France | ||
| 12 | CHU de Nimes | Nîmes | France | 30029 | |
| 13 | Hôpital Saint Antoine (AP-HP) | Paris | France | ||
| 14 | Hôpital Pontchaillou | Rennes | France | ||
| 15 | Hôpital Charles-Nicolle | Rouen | France | ||
| 16 | Hôpital Purpan - CHU de Toulouse | Toulouse | France |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nīmes
Investigators
- Principal Investigator: Michel Prudhomme, MD, CHU Nimes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NIMAO/2018-02/MP-01