Risk Stratification for Abdominal Emergency Surgery: a Cohort Study

Active, not recruiting

• Conditions: Emergency Surgery

• Registration Number: NCT06501170
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2024-06-01
• Study First Submitted: 2024-06-26
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-15
• Status Verified: 2025-02
• Primary Completion: 2025-02-27
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
in-hospital mortality	From date of surgery until discharge day, assessed up to 4 weeks	documented in-hospital mortality
in-hospital morbidity	From date of surgery until discharge day, assessed up to 4 weeks	in-hospital postoperative complications classified using Clavein-Dindo score

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lu Che; 🇨🇳 Beijing, Beijing, China