Emergency SurgeryNCT06501170
Risk Stratification for Abdominal Emergency Surgery: a Cohort Study
An observational study of Emergency Surgery, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Emergency Surgery
- What is being tested?
- Retrospective Data Analysis of Emergency Abdominal Surgery Outcomes
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing emergency abdominal surgery at a single tertiary care institution between January 1, 2023, and June 1, 2024.
Who may be able to join
- Patients undergoing emergency abdominal surgery at a single tertiary care institution between January 1, 2023, and June 1, 2024
Who cannot join
- Repeated surgery for the same patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Emergency Surgery
- Being tested
- Retrospective Data Analysis of Emergency Abdominal Surgery Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective Data Analysis of Emergency Abdominal Surgery OutcomesOther
Retrospective Data Analysis of Emergency Abdominal Surgery Outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospital mortality
documented in-hospital mortality
Measured: From date of surgery until discharge day, assessed up to 4 weeks
in-hospital morbidity
in-hospital postoperative complications classified using Clavein-Dindo score
Measured: From date of surgery until discharge day, assessed up to 4 weeks
Secondary outcomes (2)
postoperative length of hospital stay
postoperative length of hospital stay assessed by days
Measured: From date of surgery until discharge day, assessed up to 4 weeks
Health care costs
Health care costs in RMB assessed using hospital billing records
Measured: From date of admission until discharge day, assessed up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 Jun 2024
- Primary completion27 Feb 2025
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency SurgeryStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501170
- Sponsor's protocol ID
- K6243
- Status last verified
- Feb 2025
- First submitted
- 26 Jun 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Adverse Outcomes After Emergency Abdominal Emergency Surgery and Establishment of a Risk Stratification Tool
- ClinicalTrials.gov ID
- NCT06501170
- Acronym / sponsor ID
- K6243
- Conditions
- Emergency Surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing emergency abdominal surgery at a single tertiary care institution between January 1, 2023, and June 1, 2024.
Key inclusion criteria (1 listed)
- Patients undergoing emergency abdominal surgery at a single tertiary care institution between January 1, 2023, and June 1, 2024
Key exclusion criteria (1 listed)
- Repeated surgery for the same patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective Data Analysis of Emergency Abdominal Surgery OutcomesRetrospective Data Analysis of Emergency Abdominal Surgery Outcomes | Other | – |
Primary outcome
in-hospital mortality
Time frame: From date of surgery until discharge day, assessed up to 4 weeks
documented in-hospital mortality
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
2 secondary outcomes
postoperative length of hospital stay
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Emergency Surgery
Recruiting
Aspiration Risk Assessment by Gastric Ultrasound in eMErgency Surgery and ANesThetic Decision-making: The ARGUMENT Study
Pulmonary Aspiration, Emergency Surgery
Not yet recruitingObservational study
Cumulative Intra-Abdominal Pressure Burden and Acute Kidney Injury After Emergency Abdominal Surgery
Acute Kidney Injury, Intra-Abdominal Hypertension
Active, not recruitingPhase 4
Early vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery
Laparotomy, Bowel Obstruction
Recruiting
Effect of Opioid-sparing Anesthesia on Quality of Recovery After Emergency Laparotomy
Emergency Abdominal Surgery, Opioid Sparing Anaesthesia
Not yet recruitingObservational study
Prediction of Difficult Mask Ventilation in Obese Population Undergoing Emergency Surgery
Difficult Airway Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Surgery, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-hospital mortality (time frame: From date of surgery until discharge day, assessed up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.