Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Prolonged Surgery

Postoperative Death Clinical Trial

Official title:

Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Prolonged Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04926025
• Other study ID #: PODSV2
• Status: Not yet recruiting
• Start date: July 30, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: Huazhong University of Science and Technology
• Contact: Yu Wang, Dr.
• Phone: +86 15972918891
• Email: wangdayuanesthe[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The investigators are aimed to develop and externally validate a prediction model of clinical risk factors that quantifies postoperative death after prolonged surgery.

The investigators identify all patients undergoing prolonged surgery which the operation time >3 h, between 2000 and 2020, within the Wuhan Union hospital and all collaborators. The surgical patient cohort will be matched with the National Death database to determine the patient's postoperative death data.

60% patients were randomly selected to the development cohort. Logistic regression analysis for prediction of postoperative death adjusted for different covariates. The model was externally validated in the remaining 40% patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients Undergoing Prolonged Surgery

Exclusion Criteria:

• Patients with incomplete electronic medical record information

Related Conditions & MeSH terms

• Death
• Postoperative Death

Locations

Country	Name	City	State
China	National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention	Beijing	Beijing
China	Xiangya Hospital, Hunan, China	Changsha	Hunan
China	Shanxi Bethune hospital, Shanxi, China	Taiyuan	Shanxi
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Henan People's Hospital, Henan, China	Zhengzhou	Henan

Sponsors (5)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	Henan People's Hospital, Henan, China, National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Shanxi Bethune hospital, Shanxi, China, Xiangya Hospital, Hunan, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Death		The mortality within 5 years after the prolonged surgery