NCT04926025

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 30, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

1.4 years

First QC Date

June 9, 2021

Last Update Submit

July 21, 2021

Conditions

Postoperative Death

Keywords

Postoperative deathProlonged surgeryPrediction model

Outcome Measures

Primary Outcomes (1)

  • Postoperative Death

    The mortality within 5 years after the prolonged surgery

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients Undergoing Prolonged Surgery

You may qualify if:

  • Patients Undergoing Prolonged Surgery

You may not qualify if:

  • Patients with incomplete electronic medical record information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention

Beijing, Beijing Municipality, 100050, China

Location

Henan People's Hospital, Henan, China

Zhengzhou, Henan, 450003, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Xiangya Hospital, Hunan, China

Changsha, Hunan, 410008, China

Location

Shanxi Bethune hospital, Shanxi, China

Taiyuan, Shanxi, 030032, China

Location

Central Study Contacts

Yu Wang, Dr.

CONTACT

+86 15972918891wangdayuanesthe@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 14, 2021

Study Start

July 30, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

July 26, 2021

Record last verified: 2021-07

Locations

CN(5)