Postoperative Recovery in Elderly Patients Assessed With QoR-15E

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age80+
SponsorHospital Universitari Vall d'Hebron Research Institute

About this trial

Postoperative recovery in elderly patients is an important part of the surgical process and affects how patients feel after surgery. To date, recovery has been measured mostly with clinical outcomes, such as complications or length of stay, but not from the patient's perspective. The QoR-15 questionnaire was designed to assess recovery from the patient's point of view and has recently been validated in Spanish as the QoR-15E.

This study aims to evaluate postoperative recovery in patients aged 80 years and older undergoing elective surgery with hospital admission, using the QoR-15E questionnaire. Patients will complete the questionnaire before surgery and on postoperative days 1, 2, 7, and 30. Additional assessments will include frailty and delirium scales, and postoperative complications will be recorded. Mortality will be evaluated 90 days after surgery, alongside the patient's subjective perception of their recovery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 80 years or older.

Undergoing elective surgery requiring hospital admission.

Able to understand and provide written informed consent.

Disqualifiers

Inability to speak Spanish.

Pre-existing cognitive impairment.

Emergency or urgent surgery.

Neurosurgical or cardiac surgical procedures.

Trial population

The study population includes patients aged 80 years and older who are undergoing elective surgery requiring hospital admission. Participants must be able to understand and provide written informed consent. Patients who do not speak Spanish, have pre-existing cognitive impairment, undergo emergency or urgent surgery, undergo neurosurgical or cardiac procedures, or have ambulatory (outpatient) surgery without hospital admission will be excluded.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • QoR-15E questionnaire.

    Diagnostic test

    A first QoR-15E questionnaire will be completed at baseline (T0) (before surgery). Other QoR-15E questionnaires will be completed at 24h (T1), 48h (T2), day 7 (T3) and day 30 (T4) after surgery.

  • Clinical Frailty Scale

    Diagnostic test

    The Clinical Frailty Scale will be administered before surgery to determine patients' clinical fragility

  • Confusional Assessment Method

    Other intervention

    We will use the "Confusional Assessment Method" to assess the presence of confusion or delirium in the immediate postoperative period.

  • Post-Operative Morbidity Survey

    Other intervention

    Postoperative morbidity will be collected through the POMS survey.

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: Patients aged 80 years and older undergoing elective surgery requiring hospital admission4 interventions

Trial outcomes

Primary outcomes

1

Postoperative quality of recovery (QoR-15E)

The QoR-15E questionnaire evaluates patient-reported quality of recovery after surgery. It includes 15 items covering physical, emotional, and psychological recovery domains.

Time frame
Preoperatively and on postoperative days 1, 2, 7, and 30

Secondary outcomes

1

Problems interfering with postoperative recovery assessed by the QoR-15E questionnaire.

Items of the QoR-15E questionnaire indicating difficulties in physical, emotional, or psychological recovery will be analyzed to identify problems that interfere with overall postoperative recovery.

Time frame
Preoperatively and on postoperative days 1, 2, 7, and 30
2

Contribution to optimization of ERAS and Multimodal Rehabilitation programs assessed by QoR-15E and clinical recovery indicators

Patient-reported outcomes (QoR-15E) and clinical recovery indicators will be analyzed to identify areas for optimizing ERAS and Multimodal Rehabilitation programs in elderly patients undergoing elective surgery.

Time frame
Preoperatively and on postoperative days 1, 2, 7, and 30
3

Contribution to clinical decision-making based on QoR-15E recovery scores

QoR-15E questionnaire results will be analyzed to support postoperative clinical decision-making in elderly patients, evaluating recovery across physical, emotional, and psychological domains.

Time frame
Preoperatively and on postoperative days 1, 2, 7, and 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Universitari Vall d'Hebron Research Institute

Lead sponsor

Hospital de la Santa creu i Sant Pau - Barcelona

Collaborator

Hospital Clinic of Barcelona

Collaborator

Hospital Vall d'Hebron

Collaborator

Hospital del Mar

Collaborator