Quality of RecoveryFQoR-15UNCT04845763
Validation of the QoR-15 Score for Emergency Surgery
An observational study of Quality of Recovery and Perioperative Complication, run by University Hospital, Angers.
Trial summary
Recovery from surgery is a complex process, depending on the characteristics of the patient, the anesthesia used, and the time required for surgical management. In the context of emergency surgery, the perioperative period is associated with an increase in morbidity and mortality, which may lead us to suspect an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Recovery, Perioperative Complication, Anesthesia
- What is being tested?
- FQoR-15 questionnaire
- Type of treatment
- Pill or oral medicine
- How many people
- 375 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 1 May 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted for emergency surgery
Who may be able to join
- ≥ 18 years old,
- French speaking,
- Admitted for any type of urgent surgery (time to surgery < 72 hours) traumaor not
- Able to answer the questionnaire at hospital admission, alone or with the help of a third party,
- And agreeing to participate in the study.
Who cannot join
- Patients with psychiatric or neurological pathologies that compromise cooperation with the protocol,
- Patients admitted for cardiac surgery or obstetrical surgery (caesarean section),
- Patients admitted for revision surgery,
- Patients already included in the study during a previous admission.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Validation of the QoR-15 Score for Assessing Quality of Recovery From Emergency Surgery and Its Association With Long-term Quality of Life.
Recovery from surgery is a complex process, depending on the characteristics of the patient, the anesthesia used, and the time required for surgical management.
In the context of emergency surgery, the perioperative period is associated with an increase in morbidity and mortality, which may lead us to suspect an alteration in the quality of recovery.
Read more
Different scales to measure the quality of post-operative recovery have been developed. The QoR-40 and QoR-15 questionnaires assess recovery after elective surgery.These scoring tools accurately measure postoperative recovery by addressing key domains: pain, physical comfort, physical independence, psychological support and emotional state. Their use is recommended as an endpoint for assessing patient comfort in clinical trials, according to the Standardized Endpoints in Perioperative Medicine (StEP) initiative. In addition, monitoring of the QoR-15 is recommended by the American Society for Enhanced Recovery. A recent French translation of the QoR-15 score has been validated for use in scheduled surgery.
All of these scores, regardless of the language in which they are translated, have been developed and validated in patients who have undergone scheduled surgery. Until now, no validated scoring tool has been available to assess recovery after emergency surgery, whether traumatological or not.
Read the detailed description
Recovery from surgery is a complex process, depending on the characteristics of the patient, the anesthesia used, and the time required for surgical management. This event is a source of stress, anxiety, pain, and even complications, both minor (nausea, vomiting) and major (such as surgical revision). The perioperative management and the psychological support allocated to each patient will have an impact on the hospitalization experience.
In the context of emergency surgery, the perioperative period is associated with an increase in morbidity and mortality, which may lead us to suspect an alteration in the quality of recovery.
Most clinical studies are interested in the reduction of perioperative morbidity and mortality (e.g. decrease in pain intensity measured by a visual analog scale, decrease in the frequency of nausea/vomiting, decrease in the time to remobilization, etc.) but still few of them evaluate in a global way the recovery, in particular in the emergency context.
Currently there is a desire to improve the physical and psychological recovery of our patients. In this context, scales to measure the quality of post-operative recovery have been developed. The QoR-40 and QoR-15 questionnaires assess recovery after elective surgery.These scoring tools accurately measure postoperative recovery by addressing key domains: pain, physical comfort, physical independence, psychological support and emotional state. Their use is recommended as an endpoint for assessing patient comfort in clinical trials, according to the Standardized Endpoints in Perioperative Medicine (StEP) initiative. In addition, monitoring of the QoR-15 is recommended by the American Society for Enhanced Recovery. A recent French translation of the QoR-15 score has been validated for use in scheduled surgery.
All of these scores, regardless of the language in which they are translated, have been developed and validated in patients who have undergone scheduled surgery. Until now, no validated scoring tool has been available to assess recovery after emergency surgery, whether traumatological or not.
- Conditions
- Quality of Recovery, Perioperative Complication, Anesthesia, Patient Reported Outcome Measures, Surgery, Postoperative Complications
- Being tested
- FQoR-15 questionnaire
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FQoR-15 questionnaireOther
The FQoR-15 questionnaire (French version) consists of 15 questions concerning five domains (the patient's feelings, comfort, pain, dependence on the health care team and psychological well-being). Two to three minutes are required to complete all the questions. If the patient is not able to read the questionnaire himself, a third person can ask the patient the questions orally. In the case of ambulatory surgery, the patient is contacted by telephone to answer the questionnaire. Each item is scored from 0 to 10 and the total score is the sum of the score obtained for each item, i.e. a score from 0 to 150.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Each patient complete the french version of the QoR-15 score (FQoR-15) at 3 times (before surgery, on Day 1, on Day 2). Receives: Other: FQoR-15 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of FQoR-15 questionnaire (24 hours)
Evaluate the validity of the French version of the QoR-15 to assess immediate postoperative recovery after emergency surgery (at 24 hours)
Measured: At 24 hours after surgery
Validity of FQoR-15 questionnaire (48 hours)
Evaluate the validity of the French version of the QoR-15 to assess immediate postoperative recovery after emergency surgery (at 48 hours)
Measured: At 48 hours after surgery
Secondary outcomes (4)
Validity of FQoR-15 questionnaire for trauma surgery
Ensure the validity of the questionnaire in the sub-population of trauma emergency surgery at 24 and 48 hours
Measured: At 24 and 48 hours after surgery
Validity of FQoR-15 questionnaire for non-traumatic surgery
Ensure the validity of the questionnaire in the sub-population of non-traumatic emergency surgery at 24 and 48 hours
Measured: At 24 and 48 hours after surgery
Minimal important difference
Estimate minimal important difference from the FQoR-15 questionnaire in the emergency surgery population.
Measured: At 24 and 48 hours after surgery
Quality of life (EQ5D-3L)
To study the association between the quality of postoperative recovery (both at 24 hours and at 48 hours of surgery) with quality of life at 3 months (measured by the EQ5D-3L visual analog scale)
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality of RecoveryStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845763
- Sponsor's protocol ID
- FQoR-15U
- Acronym
- FQoR-15U
- Status last verified
- Apr 2021
- First submitted
- 11 Apr 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leger M, Campfort M, Cayla C, Parot-Schinkel E, Lasocki S, Rineau E. Validation of an alternative French version of the Quality of Recovery-15 Score: the FQoR-15. Br J Anaesth. 2020 Oct;125(4):e345-e347. doi: 10.1016/j.bja.2020.05.052. Epub 2020 Jul 9. No abstract available.
PubMed 32654751Le Bescond V, Petit-Phan J, Campfort M, Nicolleau C, Conte M, Bouhours G, Rony L, Lasocki S, Leger M. Validation of the postoperative Quality of Recovery-15 questionnaire after emergency surgery and association with quality of life at three months. Can J Anaesth. 2024 May;71(5):590-599. doi: 10.1007/s12630-024-02722-4. Epub 2024 Mar 19.
PubMed 38504036
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the QoR-15 Score for Assessing Quality of Recovery From Emergency Surgery and Its Association With Long-term Quality of Life.
- ClinicalTrials.gov ID
- NCT04845763
- Acronym / sponsor ID
- FQoR-15U / FQoR-15U
- Conditions
- Quality of Recovery, Perioperative Complication, Anesthesia, Patient Reported Outcome Measures, Surgery, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 15 Apr 2021 (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.
Recovery from surgery is a complex process, depending on the characteristics of the patient, the anesthesia used, and the time required for surgical management.
In the context of emergency surgery, the perioperative period is associated with an increase in morbidity and mortality, which may lead us to suspect an alteration in the quality of recovery.
Different scales to measure the quality of post-operative recovery have been developed. The QoR-40 and QoR-15 questionnaires assess recovery after elective surgery.These scoring tools accurately measure postoperative recovery by addressing key domains: pain, physical comfort, physical independence, psychological support and emotional state. Their use is recommended as an endpoint for assessing patient comfort in clinical trials, according to the Standardized Endpoints in Perioperative Medicine (StEP) initiative. In addition, monitoring of the QoR-15 is recommended by the American Society for Enhanced Recovery. A recent French translation of the QoR-15 score has been validated for use in scheduled surgery.
All of these scores, regardless of the language in which they are translated, have been developed and validated in patients who have undergone scheduled surgery. Until now, no validated scoring tool has been available to assess recovery after emergency surgery, whether traumatological or not.
Detailed description
Recovery from surgery is a complex process, depending on the characteristics of the patient, the anesthesia used, and the time required for surgical management. This event is a source of stress, anxiety, pain, and even complications, both minor (nausea, vomiting) and major (such as surgical revision). The perioperative management and the psychological support allocated to each patient will have an impact on the hospitalization experience.
In the context of emergency surgery, the perioperative period is associated with an increase in morbidity and mortality, which may lead us to suspect an alteration in the quality of recovery.
Most clinical studies are interested in the reduction of perioperative morbidity and mortality (e.g. decrease in pain intensity measured by a visual analog scale, decrease in the frequency of nausea/vomiting, decrease in the time to remobilization, etc.) but still few of them evaluate in a global way the recovery, in particular in the emergency context.
Currently there is a desire to improve the physical and psychological recovery of our patients. In this context, scales to measure the quality of post-operative recovery have been developed. The QoR-40 and QoR-15 questionnaires assess recovery after elective surgery.These scoring tools accurately measure postoperative recovery by addressing key domains: pain, physical comfort, physical independence, psychological support and emotional state. Their use is recommended as an endpoint for assessing patient comfort in clinical trials, according to the Standardized Endpoints in Perioperative Medicine (StEP) initiative. In addition, monitoring of the QoR-15 is recommended by the American Society for Enhanced Recovery. A recent French translation of the QoR-15 score has been validated for use in scheduled surgery.
All of these scores, regardless of the language in which they are translated, have been developed and validated in patients who have undergone scheduled surgery. Until now, no validated scoring tool has been available to assess recovery after emergency surgery, whether traumatological or not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Other: FQoR-15 questionnaireEach patient complete the french version of the QoR-15 score (FQoR-15) at 3 times (before surgery, on Day 1, on Day 2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted for emergency surgery
Key inclusion criteria (5 listed)
- ≥ 18 years old,
- French speaking,
- Admitted for any type of urgent surgery (time to surgery < 72 hours) traumaor not
- Able to answer the questionnaire at hospital admission, alone or with the help of a third party,
- And agreeing to participate in the study.
Key exclusion criteria (4 listed)
- Patients with psychiatric or neurological pathologies that compromise cooperation with the protocol,
- Patients admitted for cardiac surgery or obstetrical surgery (caesarean section),
- Patients admitted for revision surgery,
- Patients already included in the study during a previous admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FQoR-15 questionnaireThe FQoR-15 questionnaire (French version) consists of 15 questions concerning five domains (the patient's feelings, comfort, pain, dependence on the health care team and psychological well-being). Two to three minutes are required to complete all the questions. If the patient is not able to read the questionnaire himself, a third person can ask the patient the questions orally. In the case of ambulatory surgery, the patient is contacted by telephone to answer the questionnaire. Each item is scored from 0 to 10 and the total score is the sum of the score obtained for each item, i.e. a score from 0 to 150. | Other | Intervention |
Primary outcome
Validity of FQoR-15 questionnaire (24 hours)
Time frame: At 24 hours after surgery
Evaluate the validity of the French version of the QoR-15 to assess immediate postoperative recovery after emergency surgery (at 24 hours)
Validity of FQoR-15 questionnaire (48 hours)
Time frame: At 48 hours after surgery
Evaluate the validity of the French version of the QoR-15 to assess immediate postoperative recovery after emergency surgery (at 48 hours)
4 secondary outcomes
Validity of FQoR-15 questionnaire for trauma surgery
Time frame: At 24 and 48 hours after surgery
Validity of FQoR-15 questionnaire for non-traumatic surgery
Time frame: At 24 and 48 hours after surgery
Minimal important difference
Time frame: At 24 and 48 hours after surgery
Quality of life (EQ5D-3L)
Time frame: 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Background: PubMed 32654751Leger M, Campfort M, Cayla C, Parot-Schinkel E, Lasocki S, Rineau E. Validation of an alternative French version of the Quality of Recovery-15 Score: the FQoR-15. Br J Anaesth. 2020 Oct;125(4):e345-e347. doi: 10.1016/j.bja.2020.05.052. Epub 2020 Jul 9. No abstract available.
- Derived from this study: PubMed 38504036Le Bescond V, Petit-Phan J, Campfort M, Nicolleau C, Conte M, Bouhours G, Rony L, Lasocki S, Leger M. Validation of the postoperative Quality of Recovery-15 questionnaire after emergency surgery and association with quality of life at three months. Can J Anaesth. 2024 May;71(5):590-599. doi: 10.1007/s12630-024-02722-4. Epub 2024 Mar 19.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Recovery and Perioperative Complication, run by University Hospital, Angers.
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 5 inclusion and 4 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 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Maxime Léger, MD (2 41 35 36 35 ext. +33, maxime.leger@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of FQoR-15 questionnaire (24 hours) (time frame: At 24 hours after surgery). The study lists 2 primary outcomes in all. 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 NCT04845763, which also lists 2 linked publications.
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 15 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.