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NCT Number: NCT06501170

Risk Stratification for Abdominal Emergency Surgery: a Cohort Study

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

Lu Che

Beijing, Beijing Municipality, 100073, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retrospective Data Analysis of Emergency Abdominal Surgery Outcomes

Other

Retrospective Data Analysis of Emergency Abdominal Surgery Outcomes

Primary outcomes

  1. in-hospital mortality

    Time frame: From date of surgery until discharge day, assessed up to 4 weeks

    documented in-hospital mortality

  2. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2024
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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