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Validation of the QoR-15 Score for Emergency Surgery (FQoR-15U)

U

University Hospital, Angers

Status

Unknown

Conditions

Postoperative Complications
Perioperative Complication
Quality of Recovery
Emergency Surgery
Surgery
Patient Reported Outcome Measures
Anesthesia

Treatments

Other: FQoR-15 questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT04845763
FQoR-15U

Details and patient eligibility

About

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.

Full 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.

Enrollment

375 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

375 participants in 1 patient group

Intervention
Description:
Each patient complete the french version of the QoR-15 score (FQoR-15) at 3 times (before surgery, on Day 1, on Day 2).
Treatment:
Other: FQoR-15 questionnaire

Trial contacts and locations

0

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Central trial contact

Maxime Léger, MD; Béatrice Gable

Data sourced from clinicaltrials.gov

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