Postoperative Complications in Major Surgery (SURGCOM)

May 27, 2026 updated by: Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background and Rationale: Postoperative complications impose a substantial clinical and economic burden worldwide. While extensive research has focused on patient-derived clinical risks, fewer prospective international studies have mathematically integrated hospital structural capabilities and perioperative safety processes into multi-level predictive frameworks. This protocol describes an international, prospective, multicenter cohort study designed to build and validate a predictive model for adverse surgical outcomes. Study Design and Population: This is a multicenter, prospective cohort study. Participating centers will recruit consecutive adult or pediatric patients undergoing major elective or emergency non-cardiac surgery. Major surgery is defined internationally as any procedure requiring general or neuraxial anesthesia with an anticipated duration > 90 minutes, estimated blood loss > 500 mL, or requiring routine postoperative intensive care admission. Patients undergoing minor procedures or those unable to provide informed consent will be excluded. Data Collection and Covariates: Standardized electronic case report forms (eCRFs) will be used to collect data across three main tiers: 1. Patient-level Predictors: Demographics, insurance coverage, American Society of Anesthesiologists (ASA) physical status, Charlson Comorbidity Index, and frailty (measured via the Modified Frailty Index, mFI-5). 2. Procedure: code of surgery. 3. Type of surgery: Emergency/elective surgery, Ambulatory/hospitalized, severity, specialty. Outcomes and Follow-up: All participants will be systematically tracked during their inpatient stay, with mandatory clinical follow-up at postoperative day 30 (via medical record review). Primary Outcome: Composite incidence of major 30-day postoperative complications, graded according to the Clavien-Dindo classification (Grade > III, indicating complications requiring surgical, endoscopic, or radiological intervention, life-threatening complications, or death). Secondary Outcomes: 30-day all-cause mortality, individual complication rates (surgical site infections, major bleeding, thromboembolic events, organ failure), hospital length of stay, and "Failure to Rescue" rates (proportion of patients who die after developing a major complication). Statistical Analysis and Predictive Modeling: Sample size calculations are based on the Events Per Variable (EPV) criterion, ensuring a minimum of 15-20 events per candidate predictor in the multivariable model to prevent overfitting. Multilevel multivariable logistic regression and mixed-effects Cox proportional hazards models will be constructed, treating the hospital/country of origin as a random effect to account for institutional clustering. Model performance will be rigorously evaluated. Discriminatory capacity will be assessed using the area under the receiver operating characteristic curve (AUROC). Calibration will be assessed via calibration curves (observed vs. predicted risk). Sensitivity analyses will compare traditional regression models. Reporting will adhere strictly to TRIPOD and STROBE guidelines.

Study Type

Observational

Enrollment (Estimated)

364

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Colombia
    • Meta Department
      • Villavicencio, Meta Department, Colombia, 50001
        • Hospital Departamental de Villavicencio
        • Contact:
        • Contact:
        • Principal Investigator:
          • Norton Perez-Gutiérrez, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Major surgery
  • Adult or pediatric patients
  • Emergency or elective surgery
  • Ambulatory or hospitalized patients

Exclusion Criteria:

  • Patients derived to other institution

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Complications
Patients with postoperative complications
Other: Patients with postoperative complications
Patients with observed complications (Clavien-Dindo >3)
No complications
Patients with no postoperative complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined complications
Time Frame: 30 days
Postoperative complications by Clavien-Dindo classification > 3
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days
Patients with postoperative mortality before discharge or within 30 days.
30 days
Surgical site infection
Time Frame: 30 days
Surgical site infection according to clinical charts
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Departamental de Villavicencio

Investigators

  • Principal Investigator: Norton Perez-Gutiérrez, MD, Hospital Departamental de Villavicencio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

August 30, 2027

Study Registration Dates

First Submitted

May 27, 2026

First Submitted That Met QC Criteria

May 27, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GRIVI_2026_01_QX_COMPLIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient information involved.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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