Ignite Creation Date:
2024-07-17 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501170
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-26
Brief Title:
Risk Stratification for Abdominal Emergency Surgery a Cohort Study
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Risk Factors of Adverse Outcomes After Emergency Abdominal Emergency Surgery and Establishment of a Risk Stratification Tool
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 inputoutput IO inotropicvasopressor 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
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 inputoutput IO inotropicvasopressor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None