Validation of the QoR-15 Score for Emergency Surgery

NCT04845763 | Unknown

• 1 other identifier: FQoR-15U
• Study Type: observational
• Target: 375
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  At 48 hours after surgery

Secondary Outcomes (4)

• Validity of FQoR-15 questionnaire for trauma surgery

  At 24 and 48 hours after surgery

• Validity of FQoR-15 questionnaire for non-traumatic surgery

  At 24 and 48 hours after surgery

• Minimal important difference

  At 24 and 48 hours after surgery

• Quality of life (EQ5D-3L)

  3 months after surgery

Study Arms (1)

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).

Other: FQoR-15 questionnaire

Interventions

FQoR-15 questionnaire OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted for emergency surgery

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Angers: lead

Related Publications (2)

• 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.

  PMID: 32654751 BACKGROUND

• Le 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.

  PMID: 38504036 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maxime Léger, MD

CONTACT

2 41 35 36 35; maxime.leger@chu-angers.fr

Béatrice Gable

CONTACT

2 41 35 68 25; begable@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 15, 2021
• Study Start: June 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: May 1, 2022
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share