Postoperative Recovery in Elderly Patients Assessed With QoR-15E (PQoRE)

March 26, 2026 updated by: Hospital Universitari Vall d'Hebron Research Institute

Postoperative Quality of Recovery in Elderly Patients Undergoing Elective Surgery With Hospital Admission: a Multicenter Prospective Cohort Study Based on Patient-reported Outcome Measures (PQoRE Study)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • Barcelona, Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Contact:
      • Barcelona, Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
      • Barcelona, Barcelona, Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:
      • Barcelona, Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar de Barcelona
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  • Patients aged 80 years or older.
  • Undergoing elective surgery requiring hospital admission.
  • Able to understand and provide written informed consent.

Exclusion Criteria:

  • Inability to speak Spanish.
  • Pre-existing cognitive impairment.
  • Emergency or urgent surgery.
  • Neurosurgical or cardiac surgical procedures.
  • Ambulatory (outpatient) surgery without hospital admission.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients aged 80 years and older undergoing elective surgery requiring hospital admission
This cohort includes patients aged 80 years and older who are undergoing elective surgery requiring hospital admission. Recovery will be assessed using the QoR-15E questionnaire, completed preoperatively and on postoperative days 1, 2, 7, and 30. Additional assessments include preoperative frailty and postoperative delirium. Postoperative complications and 90-day mortality will also be recorded. No experimental interventions will be applied; all patients will receive standard perioperative care according to hospital protocols.
Diagnostic test: QoR-15E questionnaire.
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.
Other Names:
  • QoR-15E
Diagnostic test: Clinical Frailty Scale
The Clinical Frailty Scale will be administered before surgery to determine patients' clinical fragility
Other Names:
  • CFS
Other: Confusional Assessment Method
We will use the "Confusional Assessment Method" to assess the presence of confusion or delirium in the immediate postoperative period.
Other Names:
  • CAM
Other: Post-Operative Morbidity Survey
Postoperative morbidity will be collected through the POMS survey.
Other Names:
  • POMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative quality of recovery (QoR-15E)
Time Frame: Preoperatively and on postoperative days 1, 2, 7, and 30
The QoR-15E questionnaire evaluates patient-reported quality of recovery after surgery. It includes 15 items covering physical, emotional, and psychological recovery domains.
Preoperatively and on postoperative days 1, 2, 7, and 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Problems interfering with postoperative recovery assessed by the QoR-15E questionnaire.
Time Frame: Preoperatively and on postoperative days 1, 2, 7, and 30
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.
Preoperatively and on postoperative days 1, 2, 7, and 30
Contribution to optimization of ERAS and Multimodal Rehabilitation programs assessed by QoR-15E and clinical recovery indicators
Time Frame: Preoperatively and on postoperative days 1, 2, 7, and 30
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.
Preoperatively and on postoperative days 1, 2, 7, and 30
Contribution to clinical decision-making based on QoR-15E recovery scores
Time Frame: Preoperatively and on postoperative days 1, 2, 7, and 30
QoR-15E questionnaire results will be analyzed to support postoperative clinical decision-making in elderly patients, evaluating recovery across physical, emotional, and psychological domains.
Preoperatively and on postoperative days 1, 2, 7, and 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborators

Hospital Clinic of Barcelona
Hospital del Mar
Hospital Vall d'Hebron
Hospital de la Santa creu i Sant Pau - Barcelona

Investigators

  • Principal Investigator: Victor Morales-Ariza, MD, Vall d'Hebron University Hospital / Universitat Autònoma de Barcelona
  • Study Chair: Miriam de Nadal, MD, PhD, Vall d'Hebron University Hospital / Universitat Autònoma de Barcelona
  • Study Director: Marcos de Miguel, MD, PhD, Vall d'Hebron University Hospital / Universitat Autònoma de Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PR(AG)06/2024
  • ISCIII grant PI24/00712 (Other Grant/Funding Number: Instituto de Salud Carlos III)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Recovery in Elderly Patients

Clinical Trials on QoR-15E questionnaire.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe