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Study of the Quality of Life of Patients Treated by Heavy Surgery as Part of an Enhanced Recovery at Beau Soleil Clinic- QUALICHIR

Sponsor
Clinique Beau Soleil (Other)
Overall Status
Completed
CT.gov ID
NCT04028934
Collaborator
(none)
19
Enrollment
1
Location
22.1
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Heavy and oncological surgery is undergoing a major evolution. Some surgical dogmas are falling and care is better rationalized. The interactions between the patient and the caregivers on the other hand, and from the caregiver to the caregiver are favored. Thus was born, about 10 years ago, the principle of enhanced recovery after surgery (ERAS).

But recovery has improved in the patient in the best possible shape in the operating room, and, during the gesture, minimize the negative effects of surgery and anesthesia. Finally, postoperatively, to re-empower the patient as quickly as possible.

The interest of this study is the benefit of the quality of life of the patient being treated for cystectomy as part of an enhanced recovery program. This is to argue the diffusion of this program and the care teams for its realization.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    19 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study of the Quality of Life of Patients Treated by Heavy Surgery as Part of an Enhanced Recovery at Beau Soleil Clinic- QUALICHIR
    Actual Study Start Date :
    Mar 15, 2019
    Actual Primary Completion Date :
    Sep 15, 2020
    Actual Study Completion Date :
    Jan 15, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Estimation of the percentage of patients who will have a "good or very good" quality of life, when they were included in an enhanced recovery program in urology following a cystectomy [6 months]

      An overall quality of life questionnaire adapted to each pathology, on a five-level Likert scale, will make it possible to estimate the percentage of patients whose quality of life will be "good or very good". The quality of life will be estimated globally through repeated measurements at each visit. It will be considered that if more than 80% of the answers are "good or very good", the quality of life variable will be "good or very good".

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Patients with an indication of cystectomy validated by the surgical team and if there is an oncological indication by the multidisciplinary meeting of onco-urology.

    • Patient affiliated to a social security scheme

    • Patient classified ASA from 1 to 3

    • Patient informed and having accepted the principle of enhanced recovery after surgery

    Exclusion Criteria:

    • Patients classified ASA ≥4

    • Patients with severe or poorly balanced associated conditions (diabetes, long-term corticosteroid therapy, severe undernutrition, cirrhosis, immunosuppression, cardiac disease), contraindications to enhanced recovery after surgery (ERAS) may be temporary if they are corrected.

    • Patients who can not comply with the ERAS protocol because they do not understand the language or cognitive disorder.

    • Vulnerable people (Article L 1121-6 of the CSP)

    • Majors subject to legal protection or unable to express their consent (Article 1121-8 of the CSP)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lacombe Sandy Montpellier France 34070

    Sponsors and Collaborators

    • Clinique Beau Soleil

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Clinique Beau Soleil
    ClinicalTrials.gov Identifier:
    NCT04028934
    Other Study ID Numbers:
    • 2018-A01140-55
    First Posted:
    Jul 23, 2019
    Last Update Posted:
    Feb 9, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Feb 9, 2021