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Social Deprivation and Postoperative Mortality

27 maggio 2026 aggiornato da: Hospital de Clinicas de Porto Alegre

Assessment of the Impact of Socioeconomic Factors on Perioperative Outcomes

Socioeconomic factors are associated with differences in health outcomes, but their impact on surgical patients is still not well understood, especially in low- and middle-income countries. Social deprivation may affect perioperative outcomes through differences in access to healthcare, burden of comorbidities, timing of care, and hospital resources. However, few studies have evaluated this association in large and diverse surgical populations, and data from Brazil are limited.

This retrospective multicenter cohort study will evaluate the association between socioeconomic deprivation and perioperative outcomes among patients undergoing surgery in Brazil. The study will include patients aged 16 years or older who underwent elective or urgent surgical procedures in participating public and private hospitals between January 1 and December 31, 2024. Patients undergoing ophthalmologic procedures, diagnostic procedures, procedures performed under local anesthesia only, selected transplant procedures, and organ donors after brain death will be excluded.

Socioeconomic deprivation will be assessed using georeferenced area-level indices derived from each patient's residential address, including the Brazilian Deprivation Index, the Social Vulnerability Index, and the Municipal Human Development Index. The researchers will grou patients according to deprivation levels, and analyze the association between deprivation and postoperative outcomes.

The primary outcome will be 30-day in-hospital postoperative mortality. The study will also evaluate demographic, clinical, surgical, and hospital-level factors associated with mortality, including age, sex, ethnicity, American Society of Anesthesiologists physical status classification, surgical urgency, surgical magnitude, surgical specialty, and type of healthcare system. Multivariable logistic regression models will be used to assess whether socioeconomic deprivation is independently associated with postoperative mortality after adjustment for relevant clinical and surgical factors.

The results of this study may improve the understanding of how socioeconomic deprivation influences perioperative risk in Brazil. The findings may help identify vulnerable surgical patients, support risk prediction models that include social determinants of health, and inform strategies to reduce inequities in perioperative care.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

Socioeconomic deprivation is a multidimensional determinant of health that may influence perioperative outcomes through several pathways, including differences in baseline health status, burden of comorbidities, access to timely healthcare, perioperative optimization, and hospital-level resources. Although previous studies have suggested an association between social deprivation and worse postoperative outcomes, most available evidence comes from high-income countries or from studies focused on specific surgical populations. Data from low- and middle-income countries, including Brazil, remain limited.

This study is a retrospective, multicenter cohort study designed to assess the association between socioeconomic deprivation and perioperative outcomes among surgical patients treated in Brazilian hospitals. Participating centers will include both public and private hospitals from different regions of the country. The study will use routinely collected institutional data from patients who underwent surgical procedures during the 2024 calendar year. No additional contact, intervention, or change in clinical care will occur as part of the study.

The main exposure of interest is socioeconomic deprivation, assessed through georeferenced area-level indicators based on each patient's residential address. Residential addresses will be geocoded to identify the corresponding census tract or human development unit. Socioeconomic deprivation will then be measured using validated Brazilian indices, including the Brazilian Deprivation Index, the Social Vulnerability Index, and the Municipal Human Development Index. These indices capture different dimensions of socioeconomic context, including income, education, household conditions, urban infrastructure, human capital, and vulnerability related to work and income.

The study database will include demographic, clinical, surgical, and structural variables routinely available in hospital electronic records. These variables include age, sex, ethnicity, American Society of Anesthesiologists physical status classification, educational level, occupation, surgical procedure, surgical urgency, date of surgery, date of hospital discharge or in-hospital death, surgical specialty, surgical magnitude, and type of healthcare system. Surgical procedures will be standardized using Brazilian procedural classification systems (Classificação Brasileira Hierarquizada de Procedimentos Médicos -CBHPM). If a patient undergoes more than one eligible surgical procedure during the study period, only the first procedure will be considered for outcome analysis.

Data will be extracted locally by the information technology teams of participating centers using structured database queries. Identifiable patient information will not be included in the analytical dataset. Residential addresses will be used only for geocoding and linkage to area-level socioeconomic indices. After geospatial processing, the final research dataset will exclude full residential addresses and other direct identifiers. Access to study data will be restricted to authorized members of the research team, and data will be stored in a secure institutional environment.

The primary analysis will evaluate whether higher levels of socioeconomic deprivation are associated with 30-day in-hospital postoperative mortality. Deprivation indices will be analyzed in categories, including quintiles, to assess gradients of risk across socioeconomic strata. Baseline characteristics will be summarized across deprivation groups using appropriate descriptive statistics. Multivariable logistic regression models will be used to estimate the association between socioeconomic deprivation and postoperative mortality after adjustment for relevant demographic, clinical, surgical, and hospital-level factors. Planned covariates include age, sex, ethnicity, ASA physical status, surgical urgency, surgical magnitude, surgical specialty, and healthcare system type.

Model performance will be assessed using calibration and discrimination measures. Calibration will be evaluated using the Hosmer-Lemeshow goodness-of-fit test, and discrimination will be assessed using the area under the receiver operating characteristic curve. Results will be reported as odds ratios with 95% confidence intervals. A significance level of 5% will be used for statistical analyses.

The study also aims to explore whether incorporating socioeconomic deprivation into perioperative risk assessment may improve the identification of vulnerable surgical patients. By evaluating social deprivation alongside established clinical and surgical risk factors, this study may contribute to a better understanding of inequities in perioperative care and support future strategies for risk stratification, resource allocation, and quality improvement in both public and private healthcare settings in Brazil.

Tipo di studio

Osservativo

Iscrizione (Stimato)

45000

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Brasile
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brasile, 40110-060
        • Hospital das Clínicas da Universidade Federal da Bahia
        • Contatto:
    • Maranhão
      • São Luís, Maranhão, Brasile, 65060-645
    • Paraná
      • Curitiba, Paraná, Brasile, 80050-370
    • Rio Grande do Sul
      • Criciuma, Rio Grande do Sul, Brasile, 88.811-500
        • Hospital São José
        • Contatto:
      • Porto Alegre, Rio Grande do Sul, Brasile, 91350-200
        • Hospital Nossa Senhora da Conceicao
        • Contatto:
      • Porto Alegre, Rio Grande do Sul, Brasile, 90410-000
        • Hospital de Clinicas de Porto Alegre
        • Contatto:
    • São Paulo
      • São Paulo, São Paulo, Brasile, 04038-032

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Study participants will be selected from surgical patients treated at participating public and private hospitals in Brazil. The participating centers are Hospital São José in Criciúma, Santa Catarina; Hospital de Clínicas de Porto Alegre and Hospital Nossa Senhora da Conceição in Porto Alegre, Rio Grande do Sul; Hospital São Domingos in São Luís, Maranhão; Hospital Marcelino Champagnat in Curitiba, Paraná; Hospital São Paulo in São Paulo, São Paulo; and Hospital da Universidade Federal da Bahia in Salvador, Bahia.

These hospitals represent different geographic regions of Brazil and include both public and private healthcare settings.

Descrizione

Inclusion Criteria:

  • Patients aged 16 years or older.
  • Patients who underwent an elective or urgent surgical procedure in an operating room at a participating hospital.
  • Surgical procedure performed between January 1, 2024, and December 31, 2024.

Exclusion Criteria:

  • Patients who underwent ophthalmologic surgery, diagnostic procedures only and procedures performed under local anesthesia only.
  • Patients who underwent liver, lung or heart transplantation.
  • Patients diagnosed with brain death who were organ donor candidates.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
2024 Surgical Patients

Patients aged 16 years or older who underwent elective or urgent surgical procedures in participating Brazilian hospitals between January 1 and December 31, 2024. Participating centers will include public and private hospitals. The cohort will be identified retrospectively from routinely collected hospital electronic records.

There will be no study intervention and no change in patient care. The exposure of interest is socioeconomic deprivation, assessed using georeferenced area-level indices derived from each patient's residential address. Patients will be categorized according to levels of socioeconomic deprivation, and perioperative outcomes will be compared across these groups.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
30-day in-hospital postoperative mortality
Lasso di tempo: 30 days
Number of participants who died during the hospital stay within 30 days after the index surgical procedure. Mortality will be assessed using routinely collected hospital electronic records, including the date of surgery, date of hospital discharge, and date of in-hospital death when applicable. Participants discharged alive before 30 days will be considered alive for this outcome. Participants who remain hospitalized beyond 30 days will be assessed up to postoperative day 30 only. This is a binary outcome, reported as death or no death within 30 days after surgery.
30 days

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Admission to intensive care unit or regular ward after surgery
Lasso di tempo: Immediate postoperative destination
Admission to an intensive care unit or to a regular inpatient ward after the index surgical procedure. Postoperative destination will be assessed using routinely collected hospital electronic records. Intensive care unit admission will include admission to an intensive care unit or equivalent critical care unit immediately after surgery. Regular inpatient ward admission will include admission to a standard hospital ward without intensive care support. This is a categorical outcome, reported according to the first postoperative destination after surgery.
Immediate postoperative destination

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hospital de Clinicas de Porto Alegre

Collaboratori

Federal University of Rio Grande do Sul

Investigatori

  • Investigatore principale: Luciana PC Stefani, Md, PhD, Hospital de Clinicas de Porto Alegre

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 maggio 2026

Completamento primario (Stimato)

1 maggio 2027

Completamento dello studio (Stimato)

1 dicembre 2028

Date di iscrizione allo studio

Primo inviato

27 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 maggio 2026

Primo Inserito (Effettivo)

2 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 2025-0217

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared. This is a retrospective study using routinely collected hospital data from multiple participating centers, including sensitive clinical information and residential address data used for georeferencing. Although the final analytical dataset will be de-identified, sharing individual-level data could pose confidentiality risks and may not be permitted under local ethics approvals and institutional data governance agreements. Study results will be reported only in aggregate form.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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