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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| with mesh | Placement of lightweight (<50g/m2) monofilament mesh during colostomy formation | ||
| no mesh | colostomy without mesh placement |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of parastomal hernia between groups | Percentage patients with parastomal hernia taken from patient medical records | 5 years after colostomy formation |
| Date of parastomal hernia | Date of parastomal hernia taken from patient records | 5 years after colostomy formation |
| Measure | Description | Time Frame |
|---|---|---|
| Protrusion around the stoma | Yes/no | 5 years after colostomy formation |
| Patient reported pain | Yes/no | 5 years after colostomy formation |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of patients included in the GRECCAR 07 cohort.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michel Prudhomme, MD | Contact | 06.43.50.35.22 | michel.prudhomme@chu-nimes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Michel Prudhomme, MD | CHU Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| L'Hôpital Jean Minjoz | Recruiting | Besançon | France |
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| Occlusion | Yes/no | 5 years after colostomy formation |
| Incarceration | Yes/no | 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) | 5 years after colostomy formation |
| Pain at colostomy site | 0-100 scale (no pain to intolerable pain) | 5 years after colostomy formation |
| Discomfort | 0-100 scale (very uncomfortable to very comfortable) | 5 years after colostomy formation |
| Patient reported satisfaction | 0-100 scale (not at all satisfied to very satisfied) | 5 years after colostomy formation |
| Number of specialist and general consultations attended by patients between groups | number of consultations | 5 years after colostomy formation |
| Number of medications taken in each group | Number of medications taken | 5 years after colostomy formation |
| Other associated treatment received by patients in each group | number of treatments received | 5 years after colostomy formation |
| Rehabilitation sessions undergone by patients in each group | number of rehabilitation sessions | 5 years after colostomy formation |
| Sick leave taken by patients in each group | Number of days | 5 years after colostomy formation |
| Cost of patients care | Euros | 5 years after colostomy formation |
| CHU de Bordeaux | Not yet recruiting | Bordeaux | France |
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| CHRU Clermont- Ferrand Hôtel -Dieu | Recruiting | Clermont-Ferrand | France |
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| Hôpital Beaujon (AP-HP) | Not yet recruiting | Clichy | France |
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| Hôpital Albert Michallon | Not yet recruiting | Grenoble | France |
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| Centre Oscar Lambret | Recruiting | Lille | France |
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| Centre Hospitalier Lyon-Sud | Recruiting | Lyon | France |
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| Centre Régional de Lutte contre le Cancer Institut Paoli-Calmettes | Not yet recruiting | Marseille | France |
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| Hôpital La Timone, AP-HM | Not yet recruiting | Marseille | France |
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| CRLC Val d'Aurelle - Paul Lamarque | Not yet recruiting | Montpellier | France |
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| Centre Hospitalier Universitaire Hôtel-Dieu - CHU de Nantes | Recruiting | Nantes | France |
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| CHU de Nimes | Recruiting | Nîmes | 30029 | France |
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| Hôpital Saint Antoine (AP-HP) | Not yet recruiting | Paris | France |
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| Hôpital Pontchaillou | Not yet recruiting | Rennes | France |
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| Hôpital Charles-Nicolle | Recruiting | Rouen | France |
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| Hôpital Purpan - CHU de Toulouse | Recruiting | Toulouse | France |
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