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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 (QUALICHIR)

2021年2月8日更新者：Clinique Beau Soleil

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.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

法国
- - Montpellier、法国、34070
    - Lacombe Sandy

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 100年 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

概率样本

研究人群

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, and having accepted the principle of ERAS

描述

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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
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 大体时间：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".	6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Clinique Beau Soleil

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年3月15日

初级完成 (实际的)

2020年9月15日

研究完成 (实际的)

2021年1月15日

研究注册日期

首次提交

2019年7月19日

首先提交符合 QC 标准的

2019年7月19日

首次发布 (实际的)

2019年7月23日

研究记录更新

最后更新发布 (实际的)

2021年2月9日

上次提交的符合 QC 标准的更新

2021年2月8日

最后验证

2021年2月1日