Clinical trial NCT04845763: Validation of the QoR-15 Score for Emergency Surgery
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Recovery
Perioperative Complication
Anesthesia
Patient Reported Outcome Measures
Surgery
Postoperative Complications
Emergency Surgery
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2021-04-15
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted for emergency surgery

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* ≥ 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Validity of FQoR-15 questionnaire (24 hours)
timeFrame: At 24 hours after surgery
measure: Validity of FQoR-15 questionnaire (48 hours)
timeFrame: At 48 hours after surgery
Secondary outcomes:
measure: Validity of FQoR-15 questionnaire for trauma surgery
timeFrame: At 24 and 48 hours after surgery
measure: Validity of FQoR-15 questionnaire for non-traumatic surgery
timeFrame: At 24 and 48 hours after surgery
measure: Minimal important difference
timeFrame: At 24 and 48 hours after surgery
measure: Quality of life (EQ5D-3L)
timeFrame: 3 months after surgery
Other outcomes:
Locations:
Study officials:
References:
citation: 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.