Assessment of Functional Digestive and Genitourinary Outcomes in Patients With Rectal Cancer. (Rectqol)

Caen University Hospital

Status: Unknown

Conditions: Surgery; Rectal Cancer

Treatments: Other: quality of life

Study type: Interventional

Funder types: Other

Identifiers

NCT03459235

2017 - A02645-48

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

population from registry data

Experimental group

Description:

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)

Treatment:

Other: quality of life