ITMO public health
Last update : 07/22/2015 | Version : 2 | ID : 60104
| General | |
| Identification | |
| Detailed name | Monitoring a cohort with anal incontinence in the Rhône-Alpes area |
| Sign or acronym | ORALIA |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Accord CNIL |
| General Aspects | |
| Medical area |
Urology, andrology and nephrology |
| Health determinants |
Iatrogenic |
| Keywords | Medical treatment, surgical treatment, perineal re-education, additional diagnostic examinations, absence from work |
| Scientific investigator(s) (Contact) | |
| Name of the director | Damon |
| Surname | Henri |
| Address | 69437 LYON CEDEX 3 |
| Phone | 04 72 11 75 51 |
| damon.henri.heh.2014@gmail.com | |
| Unit | SERVICE EXPLORATIONS FONCTIONNELLES DIGESTIVES HOPITAL EDOUARD HERRIOT- HOSPICES CIVILS DE LYON |
| Name of the director | Mion |
| Surname | François |
| Address | 69437 LYON CEDEX 3 |
| Phone | 472110136 |
| francois.mion@chu-lyon.fr | |
| Unit | SERVICE EXPLORATIONS FONCTIONNELLES DIGESTIVES – HOPITAL EDOUARD HERRIOT |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | PHRC 2007 |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Hospices civils de Lyon |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Prospective Closing date for inclusion not determined: |
| Database objective | |
| Main objective | To assess treatment outcome (by medical, surgical and physiotherapy treatment) for patients with anal incontinence included in the ORALIA cohort and to measure any observed improvement to symptoms and quality of life. Secondary objectives: - to study the development of associated perineal disorders: constipation, urinary incontinence, sexual issues, - to estimate treatment costs proposed to patients based on their measured impact. |
| Inclusion criteria | Anal incontinence: Wexner score greater than 5/20 |
| Population type | |
| Age |
Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
Regional |
| French regions covered by the database |
Auvergne Rhône-Alpes |
| Detail of the geography area | Rhône Alpes |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 10/2002 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 621 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Paraclinical data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview Phone interview |
| Paraclinical data (detail) | Anorectal manometry, anal endosonography, defecography, electrophysiological exploration, pelvic MRI. |
| Presence of a biobank |
No |
| Health parameters studied |
Quality of life/health perception |
| Procedures | |
| Data collection method | Self-administered questionnaire: entry from a paper questionnaire; Interviews: entry from a paper questionnaire; Clinical examinations: handwritten. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 3 years |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | PMSI |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=%28Damon+H[author]+OR+Mion+F[author]%29+AND+ORALIA |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may not be used by academic or industrial teams |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
No access |
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