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

NCT ID: NCT05754268

Last Updated: 2023-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Risk Assessment Risk Factors Machine Learning Artificial Intelligence Postoperative Complications Operative Surgical Procedure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Chinese version of the surgical risk assessment system

Intervention Type PROCEDURE

There is no need to interfere with the patient. Investigators can observe the outcome after using the system for evaluation.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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luyun

OTHER

Sponsor Role lead

Responsible Party

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luyun

Chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lu Yun, Doctor

Role: STUDY_DIRECTOR

The Affiliated Hospital of Qingdao University

Locations

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Yiheng Ju

Qingdao, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ju Yiheng, Doctor

Role: CONTACT

17562468826

Facility Contacts

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Lu Yun, Doctor

Role: primary

18661802231

Other Identifiers

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CSRAS

Identifier Type: -

Identifier Source: org_study_id

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