Informations générales (source: ClinicalTrials.gov)

NCT03459235 Statut inconnu
Assessment of Functional Digestive and Genitourinary Outcomes in Patients With Rectal Cancer Living After 2 Years Without Recurrence. Population Study. (Rectqol) (Rectqol)
Interventional
  • Tumeurs du rectum
N/A
University Hospital, Caen (Voir sur ClinicalTrials)
mars 2018
juin 2018
29 juin 2024
Total mesorectal excision and neoadjuvant radio-chemotherapy have revolutionized the management of rectal cancer allowing an increase in survival (between 55 and 68% at 5 years) and allowing a decrease of local recurrence (under 10%) and allowing to push the limits of sphinctyer saving procedures. Parallel to the oncological findings, evaluating quality of life and functionnals sequelae has become a priority as highlighted by the second axis of "plan cancer 2014-2019". The prevalence of digestive functional sequelae decrease during the first two years after surgery. However, these results are difficult to analyse due to the heterogeneity of used scores in medical litterature. The low anterior resection syndrom associate poly-exoneration, gas and / or stool incontinence, urgency and stool splitting. The score of low anterior resection " LARS score " validated in Danemark in 2012 allow us to understand the complexity of these sequelae and to measure their impact on the quality of life of patients, that's why he is currently recommended. In the long term, almost two out of three patients suffer from this syndrom, with half of the patients in a severe form. However, its prevalence and severity are often underestimated by practitioners. It leads to inappropriate therapeutic measures. The aim of this study is to evaluate the impact of digestive and genito-urinary sequelae on quality of life from validated scores in patients operated curatively of rectal cancer using a population study. This study should include 676 patients with rectal cancer treated in calvados and alive at 2 years of their proctectomy without local or general recurrence.

Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
François baclesse Center - U1086 - Anticipe - 14000 - Caen - Normandie - France Yassine Eid, MD En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- Patients operated for a rectal adénocarcinoma with a curative aim with or without
neo-adjuvating treatment in Calvados between January 1st, 2007 (date of
recommendations for clinical practise) and december 31 th, 2014.

- Patients having their main address in the Calvados (at the time of diagnosis) and
recorded in the register of digestive tumors of the Calvados.

- patients alive on first of january 2018 without local recurrence nor global
recurrence

- patients able to understant a validated questionnaire.



- Dead patients

- patients with cancer recurrence

- Patient with severe cognitive disorders (confusions) preventing the good
understanding of questionnaires.