Clinical trial NCT06501170: Risk Stratification for Abdominal Emergency Surgery: a Cohort Study
Official title: Risk Factors of Adverse Outcomes After Emergency Abdominal Emergency Surgery and Establishment of a Risk Stratification Tool
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Emergency Surgery
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: in-hospital mortality
timeFrame: From date of surgery until discharge day, assessed up to 4 weeks
measure: in-hospital morbidity
timeFrame: From date of surgery until discharge day, assessed up to 4 weeks
Secondary outcomes:
measure: postoperative length of hospital stay
timeFrame: From date of surgery until discharge day, assessed up to 4 weeks
measure: Health care costs
timeFrame: From date of admission until discharge day, assessed up to 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lu Che
state: Beijing
Study officials:
References: