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

Sponsor
luyun (Other)
Overall Status
Recruiting
CT.gov ID
NCT05754268
Collaborator
(none)
10,000
1
36
278

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Establishment, Verification and Clinical Application of Chinese Version of Surgical Risk Assessment System
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. The occurrence of complications [Within one month after the operation]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yiheng Ju Qingdao Shan Dong China 266003

Sponsors and Collaborators

  • luyun

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
luyun, Chief physician, The Affiliated Hospital of Qingdao University
ClinicalTrials.gov Identifier:
NCT05754268
Other Study ID Numbers:
  • CSRAS
First Posted:
Mar 3, 2023
Last Update Posted:
Mar 7, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 7, 2023