Establishment, Verification and Clinical Application of Chinese Version of Surgical Risk Assessment System (CSRAS)

The goal of this observational study is to establish and verify the Chinese version of surgical risk assessment system and explore its clinical application. The main questions it aims to answer are: The process of establishing a Chinese version of surgical risk assessment system; What is the accuracy of the system; How can the system be used in clinic; How does this system compare with other systems (such as NSQIP). Participants will comprehensively collect the general information, examination and pathological information of the patients, using machine learning and artificial intelligence methods for data processing. Finally, the Chinese version of the surgical risk assessment system will be established. After the system is established, investigators will evaluate the accuracy of the system and compare it with other related systems.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Artificial Intelligence; Risk Factors; Machine Learning; Risk Assessment; Operative Surgical Procedure
• Intervention / Treatment: Procedure: Chinese version of the surgical risk assessment system

Detailed Description

The research process is as follows:

1. Determine the collection index and the complications to be evaluated, and retrospectively collect the preoperative clinical data (including preoperative medical records, examination and examination results) of patients with postoperative complications of gastric and colorectal cancer in our hospital in the past ten years. Preliminary construction of surgical risk assessment system (gastrointestinal surgery)
2. Retrospective or prospective collection of gastric cancer and colorectal surgery cases (not included in the system)
3. The occurrence of postoperative complications was observed until 1 month after discharge. Compare the evaluation results of the system with the actual situation and feedback to further improve the system.
4. The same batch of patient data can be input into NSQIP to re-evaluate and predict the occurrence of patient complications, and then compare the results of the two systems.
5. The incidence of postoperative complications (number of cases and accuracy) of the two groups were counted respectively, and the accuracy and practicability of the evaluation of the two systems were compared to further improve the system.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Ju Yiheng, Doctor; Phone Number: 17562468826; Email: juyiheng0815@163.com

Study Locations

• China
  • Shan Dong
    • Qingdao, Shan Dong, China, 266003
      • Recruiting
      • Yiheng Ju
      • Contact: Lu Yun, Doctor; Phone Number: 18661802231; Email: luyun@edu.qdu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Mainly collect the patients who were diagnosed as gastric cancer or colorectal cancer and received a single limited period of surgical treatment.

Description

Inclusion Criteria:

• Preoperative colonoscopy and biopsy confirmed gastric and colorectal cancer.
• Laparotomy or laparoscopic radical resection of gastric or colorectal cancer.
• No postoperative complications such as pneumonia, venous thrombosis, cardiovascular and cerebrovascular accidents occurred before operation.
• There was no serious organ dysfunction before operation.
• Complete auxiliary examination and the availability of examination and examination data were carried out before operation.

Exclusion Criteria:

• Complicated with malignant tumors of other organs.
• Unresectable tumors.
• Distant metastasis.
• Severe organ system dysfunction before operation.
• Patients with non-operative treatment.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chinese version of Surgical risk Assessment system Group; This group of patients used the Chinese version of the surgical risk assessment system to evaluate the complications.	Procedure: Chinese version of the surgical risk assessment system; There is no need to interfere with the patient. Investigators can observe the outcome after using the system for evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The occurrence of complications	The following complications occurred or did not occur in the patient: death, cardio-cerebrovascular accident, pneumonia, lower extremity deep venous thrombosis, anastomotic fistula, incision infection, intrabody periorgan infection, systemic septicemia, urinary system infection, renal insufficiency / failure, unplanned reoperation, intestinal obstruction.	Within one month after the operation

Collaborators and Investigators

• Sponsor: luyun
• Investigators: Study Director: Lu Yun, Doctor, The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): August 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 5, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: CSRAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No