Postoperative Complications in Major Surgery

ConditionMajor Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHospital Departamental de Villavicencio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Major surgery

Adult or pediatric patients

Emergency or elective surgery

Ambulatory or hospitalized patients

Disqualifiers

Patients derived to other institution

Trial population

Patients included in the study are those with a major operative procedure during a window opportunity of 7 days.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Patients with postoperative complications

    Other intervention

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

Treatment groups

364 Participants
are divided into 2 treatment groups
Group A: Complications1 intervention
Group B: No complications0 interventions

Trial outcomes

Primary outcomes

1

Combined complications

Postoperative complications by Clavien-Dindo classification \> 3

Time frame
30 days

Secondary outcomes

1

Mortality

Patients with postoperative mortality before discharge or within 30 days.

Time frame
30 days
2

Surgical site infection

Surgical site infection according to clinical charts

Time frame
30 days

Other outcomes

Sponsors and contacts

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