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| ID | Type | Description | Link |
|---|---|---|---|
| ISCIII grant PI24/00712 | Other Grant/Funding Number | Instituto de Salud Carlos III |
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| Name | Class |
|---|---|
| Hospital de la Santa creu i Sant Pau - Barcelona | OTHER |
| Hospital Clinic of Barcelona | OTHER |
| Hospital Vall d'Hebron | OTHER |
| Hospital del Mar |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Preoperatively and on postoperative days 1, 2, 7, and 30 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victor Morales Ariza, MD | Contact | +34934893000 | 6004 | victor.morales@vallhebron.cat |
| Miriam de Nadal, MD, PhD | Contact | +34934893000 | 6004 | miriam.denadal@vallhebron.cat |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar de Barcelona | Recruiting | Barcelona | Barcelona | 08003 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36414472 | Background | 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. | |
| 22795861 |
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| OTHER |
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| Clinical Frailty Scale | Diagnostic Test | The Clinical Frailty Scale will be administered before surgery to determine patients' clinical fragility |
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| Confusional Assessment Method | Other | We will use the "Confusional Assessment Method" to assess the presence of confusion or delirium in the immediate postoperative period. |
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| Post-Operative Morbidity Survey | Other | Postoperative morbidity will be collected through the POMS survey. |
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| 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. | Preoperatively and on postoperative days 1, 2, 7, and 30 |
| 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. | Preoperatively and on postoperative days 1, 2, 7, and 30 |
| Marcos de Miguel, MD, PhD | Vall d'Hebron University Hospital / Universitat Autònoma de Barcelona | Study Director |
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | Barcelona | 08035 | Spain |
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| Hospital Clinic de Barcelona | Recruiting | Barcelona | Barcelona | 08036 | Spain |
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| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Barcelona | 08041 | Spain |
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| 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. |
| 17689808 | 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. |
| 29605019 | 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. |
| 29038186 | 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. |
| 35033845 | 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. |
| 23411725 | 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. |
| 29397134 | 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. |
| 29293180 | 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. |
| 31493848 | 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. |