Colostomy Stoma, Parastomal Hernia
Conditions
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.
Interventions
None listed
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Protrusion around the stoma | 5 years after colostomy formation | Yes/no |
| 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 |
| Number of specialist and general consultations attended by patients between groups | 5 years after colostomy formation | number of consultations |
| Patient reported pain | 5 years after colostomy formation | Yes/no |
Countries
France
Contacts
Primary ContactMichel Prudhomme, MD
Outcome results
None listed