Enhanced Recovery After SurgeryQUALICHIRNCT04028934
Study of the Quality of Life of Patients Treated by Heavy Surgery as Part of an Enhanced Recovery at Beau Soleil Clinic- QUALICHIR
An observational study of Enhanced Recovery After Surgery and Cystectomy, run by Clinique Beau Soleil at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Enhanced Recovery After Surgery, Cystectomy
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2019to 15 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Enhanced Recovery After Surgery, Cystectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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".
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start15 Mar 2019
- Primary completion15 Sep 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Recovery After SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Beau Soleil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028934
- Sponsor's protocol ID
- 2018-A01140-55
- Acronym
- QUALICHIR
- Status last verified
- Feb 2021
- First submitted
- 19 Jul 2019
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04028934
- Acronym / sponsor ID
- QUALICHIR / 2018-A01140-55
- Conditions
- Enhanced Recovery After Surgery, Cystectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Clinique Beau SoleilUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enhanced Recovery After Surgery and Cystectomy, run by Clinique Beau Soleil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.