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Postoperative Recovery in Elderly PatientsPQoRENCT07505758

Postoperative Recovery in Elderly Patients Assessed With QoR-15E

An observational study of Postoperative Recovery in Elderly Patients and Quality of Recovery After Elective Surgery, run by Hospital Universitari Vall d'Hebron Research Institute at 4 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 80 years and older
What is being tested?
QoR-15E questionnaire., Clinical Frailty Scale and Confusional Assessment Method
How many people
600 participants
Where
4 sitesSpain
Study dates
4 Mar 2024to Sep 2027
How long will I take part?
3 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 80 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Victor Morales Ariza, MD contact

+34934893000 ext. 6004

victor.morales@vallhebron.cat

Miriam de Nadal, MD, PhD contact

+34934893000 ext. 6004

miriam.denadal@vallhebron.cat

Spain4 sites, 4 recruiting

  • Hospital del Mar de Barcelona

    Barcelona, Barcelona, 08003

    Study Coordinator, Hospital del Mar de Barcelona, +34932483000, victor.morales@vallhebron.cat

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona, 08035

    Victor Morales Ariza, MD, +34934893000 ext. 6004, victor.morales@vallhebron.cat

    Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, Barcelona, 08036

    Study Coordinator, Hospital Clinic de Barcelona, +34932275400, victor.morales@vallhebron.cat

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08041

    Study Coordinator, Hospital de la Santa creu i Sant Pau, +34932919000, victor.morales@vallhebron.cat

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Being tested
QoR-15E questionnaire., Clinical Frailty Scale, Confusional Assessment Method, Post-Operative Morbidity Survey
Keywords
Quality of Recovery, Patient Reported Outcome Measure, Enhanced Recovery After Surgery, Health Care Quality, Postoperative Care, Older adults

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QoR-15E questionnaire.Diagnostic test

    Also called QoR-15E

    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 ScaleDiagnostic test

    Also called CFS

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

  • Confusional Assessment MethodOther

    Also called CAM

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

  • Post-Operative Morbidity SurveyOther

    Also called POMS

    Postoperative morbidity will be collected through the POMS survey.

Study groups in NCT07505758
Study groupRoleWhat they receive
Patients aged 80 years and older undergoing elective surgery requiring hospital admissionThis 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.
Receives: Diagnostic Test: QoR-15E questionnaire.; Diagnostic Test: Clinical Frailty Scale; Other: Confusional Assessment Method; Other: Post-Operative Morbidity Survey

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Preoperatively and on postoperative days 1, 2, 7, and 30

Secondary outcomes (3)

  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.

    Measured: 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.

    Measured: 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.

    Measured: Preoperatively and on postoperative days 1, 2, 7, and 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2026
  2. Study start4 Mar 2024
  3. Primary completionMay 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07505758
Sponsor's protocol ID
PR(AG)06/2024
Other IDs
ISCIII grant PI24/00712
Acronym
PQoRE
Status last verified
Mar 2026
First submitted
22 Feb 2024
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Morales-Ariza V, Loaiza-Aldean Y, de Miguel M, Pena-Navarro M, Martinez-Silva O, Gonzalez-Tallada A, Manrique-Munoz S, de Nadal M. Validation and cross-cultural adaptation of the postoperative quality of recovery 15 (QoR-15) questionnaire for Spanish-speaking patients: A prospective cohort study. Am J Surg. 2023 Apr;225(4):740-747. doi: 10.1016/j.amjsurg.2022.11.009. Epub 2022 Nov 17.

    PubMed 36414472

  • Pelavski AD, Lacasta A, de Miguel M, Rochera MI, Roca M. Mortality and surgical risk assessment among the extreme old undergoing emergency surgery. Am J Surg. 2013 Jan;205(1):58-63. doi: 10.1016/j.amjsurg.2012.03.008. Epub 2012 Jul 15.

    PubMed 22795861

  • Grocott MP, Browne JP, Van der Meulen J, Matejowsky C, Mutch M, Hamilton MA, Levett DZ, Emberton M, Haddad FS, Mythen MG. The Postoperative Morbidity Survey was validated and used to describe morbidity after major surgery. J Clin Epidemiol. 2007 Sep;60(9):919-28. doi: 10.1016/j.jclinepi.2006.12.003. Epub 2007 May 7.

    PubMed 17689808

  • Kleif J, Gogenur I. Severity classification of the quality of recovery-15 score-An observational study. J Surg Res. 2018 May;225:101-107. doi: 10.1016/j.jss.2017.12.040. Epub 2018 Feb 21.

    PubMed 29605019

  • Carter HE, Winch S, Barnett AG, Parker M, Gallois C, Willmott L, White BP, Patton MA, Burridge L, Salkield G, Close E, Callaway L, Graves N. Incidence, duration and cost of futile treatment in end-of-life hospital admissions to three Australian public-sector tertiary hospitals: a retrospective multicentre cohort study. BMJ Open. 2017 Oct 16;7(10):e017661. doi: 10.1136/bmjopen-2017-017661.

    PubMed 29038186

  • Campfort M, Cayla C, Lasocki S, Rineau E, Leger M. Early quality of recovery according to QoR-15 score is associated with one-month postoperative complications after elective surgery. J Clin Anesth. 2022 Jun;78:110638. doi: 10.1016/j.jclinane.2021.110638. Epub 2022 Jan 13.

    PubMed 35033845

  • Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.

    PubMed 23411725

  • Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22.

    PubMed 29397134

  • Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, Fiore JF Jr, Shaw AD, Thacker JKM, Gan TJ, Miller TE, Hedrick TL, McEvoy MD, Mythen MG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M; Perioperative Quality Initiative (POQI) 2 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Patient-Reported Outcomes in an Enhanced Recovery Pathway. Anesth Analg. 2018 Jun;126(6):1874-1882. doi: 10.1213/ANE.0000000000002758.

    PubMed 29293180

  • Moonesinghe SR, Jackson AIR, Boney O, Stevenson N, Chan MTV, Cook TM, Lane-Fall M, Kalkman C, Neuman MD, Nilsson U, Shulman M, Myles PS; Standardised Endpoints in Perioperative Medicine-Core Outcome Measures in Perioperative and Anaesthetic Care (StEP-COMPAC) Group. Systematic review and consensus definitions for the Standardised Endpoints in Perioperative Medicine initiative: patient-centred outcomes. Br J Anaesth. 2019 Nov;123(5):664-670. doi: 10.1016/j.bja.2019.07.020. Epub 2019 Sep 5.

    PubMed 31493848

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Recovery in Elderly Patients and Quality of Recovery After Elective Surgery, run by Hospital Universitari Vall d'Hebron Research Institute at 4 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Victor Morales Ariza, MD (+34934893000 ext. 6004, victor.morales@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative quality of recovery (QoR-15E) (time frame: Preoperatively and on postoperative days 1, 2, 7, and 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07505758, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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