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NOT YET RECRUITING
NCT07621198

Postoperative Complications in Major Surgery

Sponsor: Hospital Departamental de Villavicencio

View on ClinicalTrials.gov

Summary

The primary objective of this study is to develop and validate a multivariable risk prediction model for 30-day major postoperative complications and mortality in patients undergoing major surgery across participating international centers. Despite advancements in perioperative care, surgical complications remain a leading cause of global morbidity and preventable death, particularly in resource-limited or low- and middle-income country (LMIC) settings. This study utilizes a prospective, multicenter, international cohort design. Data will be collected on patient-level risk factors (e.g., age, frailty, comorbidities), hospital-level infrastructure (e.g., nurse-to-patient ratios, rescue capacity), and perioperative safety processes (e.g., adherence to the WHO Surgical Safety Checklist). Patients will be followed prospectively for up to 30 days post-surgery. The collected data will be used to construct robust predictive models to identify individual patient risk and uncover actionable system-level factors to optimize surgical safety globally.

Official title: Prediction of Postoperative Complications in Major Surgery: A Prospective, Multicenter, Cohort Study in Low- and Middle-income Settings

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

364

Start Date

2026-08-01

Completion Date

2027-08-30

Last Updated

2026-06-02

Healthy Volunteers

No

Conditions

Interventions

OTHER

Patients with postoperative complications

Patients with observed complications (Clavien-Dindo \>3)

Locations (1)

Hospital Departamental de Villavicencio

Villavicencio, Meta Department, Colombia