Assessment of Functional Digestive and Genitourinary Outcomes in Patients With Rectal Cancer.
NCT ID: NCT03459235
Last Updated: 2018-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2018-03-20
2018-06-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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population from registry data
the intervention involves completing several quality of life questionnaires validated in the medical literature (LARS score, FSFI, USP, IIEF, IPPS, QLQ C-30, QLQ-CR29)
quality of life
Assessment of the impact of digestive sequelae (LARS score) and genitourinary sequelae (score IPSS, USP, FSFI et IIEF) in Patients With Rectal Cancer using validated questionnaires on quality of life (EORTC QLQ-C30 et QLQ-CR 29).
Interventions
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quality of life
Assessment of the impact of digestive sequelae (LARS score) and genitourinary sequelae (score IPSS, USP, FSFI et IIEF) in Patients With Rectal Cancer using validated questionnaires on quality of life (EORTC QLQ-C30 et QLQ-CR 29).
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* patients with cancer recurrence
* Patient with severe cognitive disorders (confusions) preventing the good understanding of questionnaires.
18 Years
80 Years
ALL
No
Sponsors
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University Hospital, Caen
OTHER
Responsible Party
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Locations
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François baclesse Center - U1086 - Anticipe
Caen, Normandy, France
Countries
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Central Contacts
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Facility Contacts
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References
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Abdelli A, Tillou X, Alves A, Menahem B. Genito-urinary sequelae after carcinological rectal resection: What to tell patients in 2017. J Visc Surg. 2017 Apr;154(2):93-104. doi: 10.1016/j.jviscsurg.2016.10.002. Epub 2017 Feb 1.
Alves A. [Recommendations for clinical practice. Therapeutic choices for rectal cancer. How can we reduce therapeutic sequelae and preserve quality of life?]. Gastroenterol Clin Biol. 2007 Jan;31 Spec No 1:1S52-62, 1S95-7. No abstract available. French.
Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.
Eid Y, Bouvier V, Menahem B, Thobie A, Dolet N, Finochi M, Renier M, Gardy J, Launoy G, Dejardin O, Morello R, Alves A; Rectqol Group. Digestive and genitourinary sequelae in rectal cancer survivors and their impact on health-related quality of life: Outcome of a high-resolution population-based study. Surgery. 2019 Sep;166(3):327-335. doi: 10.1016/j.surg.2019.04.007. Epub 2019 Jun 14.
Other Identifiers
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2017 - A02645-48
Identifier Type: -
Identifier Source: org_study_id
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