Risk Stratification for Abdominal Emergency Surgery: a Cohort Study

March 4, 2025 updated by: Peking Union Medical College Hospital

Risk Factors of Adverse Outcomes After Emergency Abdominal Emergency Surgery and Establishment of a Risk Stratification Tool

The goal of this retrospective observational study is to identify risk factors of unwanted outcomes (in-hospital morbidity and mortality) among patients undergoing emergency abdominal surgery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing emergency abdominal surgery at a single tertiary care institution with a high volume of emergency abdominal surgeries, especially for high-acuity patients, between January 1, 2023, and June 1, 2024, will be included. Baseline demographics, indication for surgery, and preoperative status (respiratory support, cardiovascular stability, Glasgow score, SOFA score, preoperative lab results, and preoperative waiting time including Time to Theatre (TTT) and Time to Knife (TTK)) will be recorded.

Definitions:

Time to Theatre (TTT): The duration from when it is determined that the patient needs surgery to the time the patient arrives at the operating theatre.

Time to Knife (TTK): The duration from when the patient enters the operating theatre to the time the first incision is made.

These data will be retrieved from the electronic health record system.

Intraoperative factors, including ASA classification, anesthesia method, type of surgical intervention, intraoperative lab results, transfusions, input/output (I/O), inotropic/vasopressor usage, and discharge ward, will also be retrieved from the electronic health record system. Postoperative outcomes, including in-hospital mortality and morbidity (complications stratified by the Clavien-Dindo classification system), will be assessed by trained investigators. Secondary outcomes include postoperative length of hospital stay and health care costs.

A statistical model will be built to identify risk factors for morbidity and mortality.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100073
        • Lu Che

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 undergoing emergency abdominal surgery at a single tertiary care institution between January 1, 2023, and June 1, 2024.

Description

Inclusion Criteria:

Patients undergoing emergency abdominal surgery at a single tertiary care institution between January 1, 2023, and June 1, 2024

Exclusion Criteria:

Repeated surgery for the same patients

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
in-hospital mortality
Time Frame: From date of surgery until discharge day, assessed up to 4 weeks
documented in-hospital mortality
From date of surgery until discharge day, assessed up to 4 weeks
in-hospital morbidity
Time Frame: From date of surgery until discharge day, assessed up to 4 weeks
in-hospital postoperative complications classified using Clavein-Dindo score
From date of surgery until discharge day, assessed up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative length of hospital stay
Time Frame: From date of surgery until discharge day, assessed up to 4 weeks
postoperative length of hospital stay assessed by days
From date of surgery until discharge day, assessed up to 4 weeks
Health care costs
Time Frame: From date of admission until discharge day, assessed up to 4 weeks
Health care costs in RMB assessed using hospital billing records
From date of admission until discharge day, assessed up to 4 weeks

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

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 (Actual)

June 1, 2024

Primary Completion (Actual)

February 27, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K6243

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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