Viewing Study NCT05754268


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Study NCT ID: NCT05754268
Status: UNKNOWN
Last Update Posted: 2023-03-07
First Post: 2023-02-21
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Establishment, Verification and Clinical Application of Chinese Version of Surgical Risk Assessment System
Sponsor: luyun
Organization:

Study Overview

Official Title: Establishment, Verification and Clinical Application of Chinese Version of Surgical Risk Assessment System
Status: UNKNOWN
Status Verified Date: 2023-03
Last Known Status: RECRUITING
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: CSRAS
Brief Summary: 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.
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 Oversight

Has Oversight DMC: False
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?: