Clinical trial NCT03459235: Assessment of Functional Digestive and Genitourinary Outcomes in Patients With Rectal Cancer.
Official title: Assessment of Functional Digestive and Genitourinary Outcomes in Patients With Rectal Cancer Living After 2 Years Without Recurrence. Population Study. (Rectqol)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Surgery
Keywords: rectal cancer
proctectomy
digestive sequelae
quality of life
Urinary and Sexual sequelae
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: 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.

Exclusion Criteria:

* Dead patients
* patients with cancer recurrence
* Patient with severe cognitive disorders (confusions) preventing the good understanding of questionnaires.

Primary outcomes:
measure: assessment of digestive sequelae in patients operated for a rectal cancer (rectal resection)
timeFrame: more than 2 years after rectal resection
measure: assessment of global quality of life in patients operated for a rectal cancer (rectal resection)
timeFrame: more than 2 years after rectal resection
measure: assessment of specific quality of life in patients operated for a rectal cancer (rectal resection)
timeFrame: more than 2 years after rectal resection
measure: assessment of quality of life of patients operated for a rectal cancer (rectal resection) - urinary sequelae (for women)
timeFrame: more than 2 years after rectal resection
measure: assessment of quality of life of patients operated for a rectal cancer (rectal resection) - urinary sequelae (for men)
timeFrame: more than 2 years after rectal resection
measure: assessment of quality of life of patients operated for a rectal cancer (rectal resection) - Sexual sequelae (for women)
timeFrame: more than 2 years after rectal resection
measure: assessment of quality of life of patients operated for a rectal cancer (rectal resection) - Sexual sequelae (for men)
timeFrame: more than 2 years after rectal resection
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: François baclesse Center - U1086 - Anticipe
state: Normandie
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.