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

NCT05754268 | Unknown

• 1 other identifier: CSRAS
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Chinese version of the surgical risk assessment system PROCEDURE

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

Chinese version of Surgical risk Assessment system Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• luyun: lead

Study Sites (1)

Yiheng Ju

Qingdao, Shandong, 266003, China

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lu Yun, Doctor

  The Affiliated Hospital of Qingdao University

  STUDY DIRECTOR

Central Study Contacts

Ju Yiheng, Doctor

CONTACT

17562468826; juyiheng0815@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 3, 2023
• Study Start: January 1, 2022
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

CN (1)