Risk AssessmentCSRASNCT05754268
Establishment, Verification and Clinical Application of Chinese Version of Surgical Risk Assessment System
An observational study of Risk Assessment and Risk Factors, run by luyun at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Risk Assessment, Risk Factors, Machine Learning
- What is being tested?
- Chinese version of the surgical risk assessment system
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Mainly collect the patients who were diagnosed as gastric cancer or colorectal cancer and received a single limited period of surgical treatment.
Who may be able to join
- 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.
Who cannot join
- Complicated with malignant tumors of other organs.
- Unresectable tumors.
- Distant metastasis.
- Severe organ system dysfunction before operation.
- Patients with non-operative treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yiheng Ju
Qingdao, Shandong, 266003
Lu Yun, Doctor, 18661802231, luyun@edu.qdu.cn
About this study
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.
Read the detailed description
The research process is as follows:
- 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)
- Retrospective or prospective collection of gastric cancer and colorectal surgery cases (not included in the system)
- 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.
- 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.
- 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
- Risk Assessment, Risk Factors, Machine Learning, Artificial Intelligence, Postoperative Complications, Operative Surgical Procedure
- Being tested
- Chinese version of the surgical risk assessment system
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese version of the surgical risk assessment systemProcedure or surgery
There is no need to interfere with the patient. Investigators can observe the outcome after using the system for evaluation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Chinese version of the surgical risk assessment system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within one month after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start1 Jan 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk AssessmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- luyun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, luyun, The Affiliated Hospital of Qingdao University
- Investigators
- Lu Yun, Doctor, Study director, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754268
- Sponsor's protocol ID
- CSRAS
- Acronym
- CSRAS
- Status last verified
- Mar 2023
- First submitted
- 21 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment, Verification and Clinical Application of Chinese Version of Surgical Risk Assessment System
- ClinicalTrials.gov ID
- NCT05754268
- Acronym / sponsor ID
- CSRAS / CSRAS
- Conditions
- Risk Assessment, Risk Factors, Machine Learning, Artificial Intelligence, Postoperative Complications, Operative Surgical Procedure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- luyunUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)
- Retrospective or prospective collection of gastric cancer and colorectal surgery cases (not included in the system)
- 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.
- 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.
- 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese version of Surgical risk Assessment system Group | – | Procedure: Chinese version of the surgical risk assessment systemThis group of patients used the Chinese version of the surgical risk assessment system to evaluate the complications. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mainly collect the patients who were diagnosed as gastric cancer or colorectal cancer and received a single limited period of surgical treatment.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Complicated with malignant tumors of other organs.
- Unresectable tumors.
- Distant metastasis.
- Severe organ system dysfunction before operation.
- Patients with non-operative treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese version of the surgical risk assessment systemThere is no need to interfere with the patient. Investigators can observe the outcome after using the system for evaluation. | Procedure or surgery | Chinese version of Surgical risk Assessment system Group |
Primary outcome
The occurrence of complications
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu Yun, Doctor study director
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Risk Assessment and Risk Factors, run by luyun at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ju Yiheng, Doctor (17562468826, juyiheng0815@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of complications (time frame: Within one month after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.