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

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.

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Key information

Conditions

Enhanced Recovery After Surgery Cystectomy

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lacombe Sandy

Montpellier, 34070, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

Time frame: 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".

Sponsors and collaborators

Lead sponsor

Clinique Beau Soleil

Other

Registry information

Acronym: QUALICHIR

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2021
First posted: Jul 23, 2019
Registry last updated: Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed