Postoperative Recovery in Elderly Patients Assessed With QoR-15E

NCT07505758 | Recruiting DMC

• 2 other identifiers: PR(AG)06/2024ISCIII grant PI24/00712
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Perioperative Care Outcomes in Older Adults; Postoperative Recovery in Elderly Patients; Quality of Recovery After Elective Surgery

Keywords

Quality of Recovery; Patient Reported Outcome Measure; Enhanced Recovery After Surgery; Health Care Quality; Postoperative Care; Older adults

Outcome Measures

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.

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

Secondary Outcomes (3)

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

  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

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

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

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

Study Arms (1)

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.; Diagnostic Test: Clinical Frailty Scale; Other: Confusional Assessment Method; Other: Post-Operative Morbidity Survey

Interventions

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.

Also known as: QoR-15E

Patients aged 80 years and older undergoing elective surgery requiring hospital admission

Clinical Frailty Scale DIAGNOSTIC_TEST

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

Also known as: CFS

Patients aged 80 years and older undergoing elective surgery requiring hospital admission

Confusional Assessment Method OTHER

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

Also known as: CAM

Patients aged 80 years and older undergoing elective surgery requiring hospital admission

Post-Operative Morbidity Survey OTHER

Postoperative morbidity will be collected through the POMS survey.

Also known as: POMS

Patients aged 80 years and older undergoing elective surgery requiring hospital admission

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital del Mar: collaborator
• Hospital Universitari Vall d'Hebron Research Institute: lead
• Hospital de la Santa creu i Sant Pau - Barcelona: collaborator
• Hospital Clinic of Barcelona: collaborator
• Hospital Vall d'Hebron: collaborator

Study Sites (4)

Hospital del Mar de Barcelona

Barcelona, Barcelona, 08003, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

RECRUITING

Related Publications (10)

• 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.

  PMID: 36414472 BACKGROUND

• 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.

  PMID: 22795861 BACKGROUND

• 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.

  PMID: 17689808 BACKGROUND

• 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.

  PMID: 29605019 BACKGROUND

• 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.

  PMID: 29038186 BACKGROUND

• 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.

  PMID: 35033845 BACKGROUND

• 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.

  PMID: 23411725 BACKGROUND

• 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.

  PMID: 29397134 BACKGROUND

• 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.

  PMID: 29293180 BACKGROUND

• 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.

  PMID: 31493848 BACKGROUND

Study Officials

• Victor Morales-Ariza, MD

  Vall d'Hebron University Hospital / Universitat Autònoma de Barcelona

  PRINCIPAL INVESTIGATOR

• Miriam de Nadal, MD, PhD

  Vall d'Hebron University Hospital / Universitat Autònoma de Barcelona

  STUDY CHAIR

• Marcos de Miguel, MD, PhD

  Vall d'Hebron University Hospital / Universitat Autònoma de Barcelona

  STUDY DIRECTOR

Central Study Contacts

Victor Morales Ariza, MD

CONTACT

+34934893000; victor.morales@vallhebron.cat

Miriam de Nadal, MD, PhD

CONTACT

+34934893000; miriam.denadal@vallhebron.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: April 1, 2026
• Study Start: March 4, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)