NCT07621211

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45,000

participants targeted

Target at P75+ for all trials

Timeline
28mo left

Started May 2026

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
May 2026Dec 2028

Study Start

First participant enrolled

May 15, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

May 27, 2026

Last Update Submit

May 27, 2026

Conditions

Keywords

surgical proceduressocial deprivationrisk factors

Outcome Measures

Primary Outcomes (1)

  • 30-day in-hospital postoperative mortality

    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

Secondary Outcomes (1)

  • Admission to intensive care unit or regular ward after surgery

    Immediate postoperative destination

Study Arms (1)

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.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hospital das Clínicas da Universidade Federal da Bahia

Salvador, Estado de Bahia, 40110-060, Brazil

Location

Hospital São Domingos

São Luís, Maranhão, 65060-645, Brazil

Location

Hospital São Marcelino Champagnat

Curitiba, Paraná, 80050-370, Brazil

Location

Hospital São José

Criciuma, Rio Grande do Sul, 88.811-500, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90410-000, Brazil

Location

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Hospital São Paulo

São Paulo, São Paulo, 04038-032, Brazil

Location

Study Officials

  • Luciana PC Stefani, Md, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Weber, Md

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2026

First Posted

June 2, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations