PREObs - Strategies for caring for the risk of venous thromboembolism in surgery for abdomino-pelvic cancer
Head :
Vignal Franck
Last update : 03/07/2016 | Version : 4 | ID : 95
| General | |
| Identification | |
| Detailed name | Strategies for caring for the risk of venous thromboembolism in surgery for abdomino-pelvic cancer |
| Sign or acronym | PREObs |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Numéro CNIL 909037, CPP = NA, Afssaps = NA |
| General Aspects | |
| Medical area |
Urology, andrology and nephrology |
| Keywords | surgical intervention |
| Scientific investigator(s) (Contact) | |
| Name of the director | Vignal |
| Surname | Franck |
| Phone | +33 (0)1 57 63 26 47 |
| franck.vignal@sanofi.com | |
| Organization | Sanofi Aventis |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Sanofi-Aventis France |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Sanofi-Aventis France |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | Describe the strategies for caring for the risk of venous thromboembolism (peri- and postoperative) in patients who must undergo surgery for abdomino-pelvic cancer. |
| Inclusion criteria |
• Over the age of 18 years.
• Hospitalized for the scheduled surgery for abdomino-pelvic cancer (digestive, urological or gynecological) • Informed Non-selection criterion: • Endoscopic approach for the cancer surgery |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) 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 |
National |
| Detail of the geography area | Metropolitan France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2009 |
| Date of last collection (YYYY or MM/YYYY) | 2011 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | in progress |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures |
| Paraclinical data (detail) | Doppler ultrasound and/or scintigraphy and/or angiography and/or spiral scanner |
| Biological data (detail) | Preoperative renal function if available:• Date• Creatininemia Preoperative blood count is available• Date of sample• Platelets / White blood cells / Hemoglobin |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | thrombosis |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/PUBMED-PREObs |
| Link to the document | http://tinyurl.com/HAL-PREObs |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | methods for accessing the database are currently being defined |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
