Recovery of FunctionQoR-15FNCT03578068
Translation and Validation of the French Version of the Postoperative Quality of Recovery Score QoR-15
An observational study of Recovery of Function, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
After a surgery, the recovery of the previous health status of patients, such as walk, body care, sleep, diet, feeling of comfort, is one of the priorities of the perioperative medicine. The QoR-15 was designed to measure quality of recovery after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recovery of Function
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2018to Aug 2019
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patient operated at Strasbourg University Hospital for a minor, intermediate or major programmed surgery
Who may be able to join
- Age ≥ 18 years
- Patient operated at Strasbourg University Hospital for a minor, intermediate or major programmed surgery
- Patient agreeing to use his data for research purposes
Who cannot join
- Patient operated on a surgery for which it is highly probable that the postoperative management does not allow him to propose the completion of the J1 questionnaire
- Patient unable to express non-opposition to participation in the study
- Patient expressing opposition to participating in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service D'Anesthesiologie - Reanimation Chirurgicale
Strasbourg, 67098
Eric Noll, MD, 33 3 88 55 23 37, eric.noll@chru-strasbourg.fr
Pierre Diemunsch, MD, 33 3 88 12 70 76, pierre.diemunsch@chru-strasbourg.fr
About this study
After a surgery, the recovery of the previous health status of patients, such as walk, body care, sleep, diet, feeling of comfort, is one of the priorities of the perioperative medicine. The QoR-15 was designed to measure quality of recovery after surgery. It provided a valid, extensive and efficient evaluation of the postoperative quality of recovery. The primary objectives of this study is to translate the original QoR-15 questionnaire into French, and do a full psychometric evaluation of the French version. We will test its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients undergoing abdominal, orthopedic, […], gynecological surgery, in the University Hospital of Strasbourg. The secondary objectives will be to evaluate the quality of recovery of the patients who undergone surgery at Strasbourg University Hospital, and to evaluate the incidence of postoperative complications occurring within three months postoperatively and a possible association with the QoR-15F.
- Conditions
- Recovery of Function
- Keywords
- Quality of Recovery, Postoperative, Surgery, French, Translation, Validation
What is being measured
The primary outcome is the main question the study is designed to answer.
QoR-15F score Title: QoR-15F score Description: Time Frame: 24h befor surgery Outcome 2 Title: QoR-15F score Description: Time Frame: 24h after surgery
the score is calculated from the questionnaire 24 hours after the surgery
Measured: 24h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start1 May 2018
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recovery of FunctionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Noll, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578068
- Sponsor's protocol ID
- 7051
- Acronym
- QoR-15F
- Status last verified
- May 2018
- First submitted
- 28 May 2018
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demumieux F, Ludes PO, Diemunsch P, Bennett-Guerrero E, Lujic M, Lefebvre F, Noll E. Validation of the translated Quality of Recovery-15 questionnaire in a French-speaking population. Br J Anaesth. 2020 Jun;124(6):761-767. doi: 10.1016/j.bja.2020.03.011. Epub 2020 Apr 15.
PubMed 32303379
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of the French Version of the Postoperative Quality of Recovery Score QoR-15
- ClinicalTrials.gov ID
- NCT03578068
- Acronym / sponsor ID
- QoR-15F / 7051
- Conditions
- Recovery of Function
- Keywords
- Quality of Recovery, Postoperative, Surgery, French, Translation, Validation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 5 Jul 2018 (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.
After a surgery, the recovery of the previous health status of patients, such as walk, body care, sleep, diet, feeling of comfort, is one of the priorities of the perioperative medicine. The QoR-15 was designed to measure quality of recovery after surgery. It provided a valid, extensive and efficient evaluation of the postoperative quality of recovery. The primary objectives of this study is to translate the original QoR-15 questionnaire into French, and do a full psychometric evaluation of the French version. We will test its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients undergoing abdominal, orthopedic, […], gynecological surgery, in the University Hospital of Strasbourg. The secondary objectives will be to evaluate the quality of recovery of the patients who undergone surgery at Strasbourg University Hospital, and to evaluate the incidence of postoperative complications occurring within three months postoperatively and a possible association with the QoR-15F.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient operated at Strasbourg University Hospital for a minor, intermediate or major programmed surgery
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Patient operated at Strasbourg University Hospital for a minor, intermediate or major programmed surgery
- Patient agreeing to use his data for research purposes
Key exclusion criteria (3 listed)
- Patient operated on a surgery for which it is highly probable that the postoperative management does not allow him to propose the completion of the J1 questionnaire
- Patient unable to express non-opposition to participation in the study
- Patient expressing opposition to participating in the study
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
QoR-15F score Title: QoR-15F score Description: Time Frame: 24h befor surgery Outcome 2 Title: QoR-15F score Description: Time Frame: 24h after surgery
Time frame: 24h after surgery
the score is calculated from the questionnaire 24 hours after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Derived from this study: PubMed 32303379Demumieux F, Ludes PO, Diemunsch P, Bennett-Guerrero E, Lujic M, Lefebvre F, Noll E. Validation of the translated Quality of Recovery-15 questionnaire in a French-speaking population. Br J Anaesth. 2020 Jun;124(6):761-767. doi: 10.1016/j.bja.2020.03.011. Epub 2020 Apr 15.
- Individual participant dataSharing planned: No
Related trials for Recovery of Function
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
Recruiting
Cervical tsDCS on Stroke Patients
Functional Recovery, Motor Rehabilitation
RecruitingPhase 2
Evaluating Intranasal Oxytocin (TNX-1900) for Pain Relief and Recovery After Pituitary Surgery
Pain, Pituitary Surgery
Not yet recruiting
Physiology of Liberation
Psychophysiological Reactivity and Recovery
Recruiting
Baduanjin Rehabilitation for Functional Restoration in ICI-Associated Myocarditis
Immune Checkpoint Inhibitors Related Myocarditis
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.
Eric Noll, MD principal investigator
University Hospital, Strasbourg, France
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 Recovery of Function, run by University Hospital, Strasbourg, France 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Noll, MD (33 3 88 55 23 37, eric.noll@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoR-15F score Title: QoR-15F score Description: Time Frame: 24h befor surgery Outcome 2 Title: QoR-15F score Description: Time Frame: 24h after surgery (time frame: 24h after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03578068, which also lists 1 linked publication.
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 5 Jul 2018.