Construction and Validation of a Prediction Model for All - Cause Mortality Within 30 Days After Surgery in Critically Ill Patients Undergoing Emergency Gastrointestinal Surgery

NCT06787157 | Not Yet Recruiting DMC

• 1 other identifier: EGS-30MP
• Study Type: observational
• Target: 900
• Locations: 0 countries
• Sites: N/A

Brief Summary

Gastrointestinal surgeries are crucial for treating digestive tract diseases. However, they often lead to high postoperative infection rates due to long durations, bacterial translocation, weakened immunity, and reduced intestinal function post-surgery. This not only impacts surgical outcomes and patient recovery but also extends hospital stays and increases financial burdens. In severe instances, it can even result in sepsis and death. The mortality risk for emergency gastrointestinal surgeries ranges from 15% to 25%. Existing scoring systems like APACHE - Ⅱ and SOFA, designed mainly for ICU patients, are insufficient for predicting the death risk of emergency gastrointestinal surgery patients. Some machine learning models for common gastric and colorectal cancer patients lack independent prospective validation. To overcome these limitations, this study at the First Hospital of Jilin University aims to construct and validate a model predicting all - cause mortality within 30 days post - emergency gastrointestinal surgery. The study proceeds in two phases. The retrospective development phase examines patients who underwent emergency gastrointestinal surgery from July 2019 to July 2024. Data is collected via the electronic medical record system, and eligible patients form the development cohort for model building. The prospective validation phase, planned to last 5 months for patient enrollment and 30 days for follow - up, is part of a half - year study. Inclusion criteria involve patients over 18, undergoing emergency gastrointestinal surgery (ICD - 10), and meeting specific critical conditions post - surgery. Exclusion criteria include superficial surgeries, significant data loss, intraoperative death, multiple injuries, and participation in other studies. Sample size calculation, based on methods by Harrell et al. and Peduzzi et al., requires at least 80 patients with events. With a 15% event incidence, the training set needs about 534 cases, the validation set 229, for a total of 763 cases (7:3 ratio). An additional 100 cases are for external validation. Investigated factors include demographics, medical history, preoperative, intraoperative, and postoperative indicators, plus pathology. The primary endpoint is 30 - day all - cause mortality, and the secondary is 30 - day postoperative complications, assessed by Clavien - Dindo classification. Data management involves CRC and double - entry. Analysis uses SPSS 25.0 and R 4.0.2. Bias is controlled through surgeon screening and surgical quality evaluation. The study has ethical approval, and patients provide informed consent. This research aims to offer clinicians a reliable model for early high - risk patient identification and precise interventions, ultimately enhancing patient outcomes.

Conditions

Emergency Gastrointestinal Surgery; Mortality Within 30 Days

Keywords

Mortality; Prediction Model; Emergency Gastrointestinal Surgery

Outcome Measures

Primary Outcomes (1)

• All causes of death within 30 days

  Died within 30 days after surgery due to various reasons.

  30 days

Study Arms (2)

Internal Validation Group

Build a prediction model

Other: Prediction Model Construction

External Validation Group

Validating a Prediction Model

Other: Prediction Model Construction

Interventions

Prediction Model Construction OTHER

External Validation Group; Internal Validation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

emergency gastrointestinal surgery patients

You may qualify if:

• Age \> 18 years old; Underwent emergency gastrointestinal surgery \[referring to the tenth edition of the International Classification of Diseases (ICD - 10)\]; Met any of the following criteria for critically ill patients after surgery: those who still required ventilator - assisted ventilation after the surgery; those who needed norepinephrine infusion at a dose \> 1.0 μg/kg/min and even required combination with other vasopressor drugs to maintain blood pressure; those with severe arrhythmia; those with combined failure of other organ functions.

You may not qualify if:

• The surgical site is superficial and does not involve the abdominal cavity. Cases with data missing by more than 30%. Patients who died during the operation, or those for whom treatment was terminated or abandoned.
• Cases complicated with multiple injuries. Patients participating in other clinical studies.

Sponsors & Collaborators

• Quan Wang: lead

Central Study Contacts

Quan Wang Professor of Medicine

CONTACT

+86 81879174; wquan@jlu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 22, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): August 20, 2027
• Study Completion (Estimated): August 20, 2027
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share