- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07259837
Association Between Preoperative Health and Functional Status and Postoperative Complications in Elderly Patients
December 7, 2025 updated by: Yanhong Liu, Chinese PLA General Hospital
Association Between Preoperative Health and Functional Status and Postoperative Complications in Elderly Patients: An Analysis of a Prospective Cohort
Using prospectively collected clinical data from the Chinese Perioperative Database of Elderly Patients, this study retrospectively analyzed patients aged ≥65 years who underwent elective non-cardiac, non-neurosurgical procedures under general anesthesia between April 2020 and April 2022.
The study examined the associations between various preoperative health and functional status assessment tools and the occurrence of cardiovascular and cerebrovascular complications within 30 days after surgery, aiming to compare the clinical value of different assessment instruments.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
8751
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100853
- Chinese PLA General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients were interviewed one day before surgery and completed a comprehensive preoperative functional status and quality of life assessment, which included the Basic Activities of Daily Living (BADL), Instrumental Activities of Daily Living (IADL), EuroQol Five-Dimension Five-Level (EQ-5D-5L), Metabolic Equivalent of Task (MET), and FRAIL scale.
Description
Inclusion criteria:
- Aged ≥65 years;
- Scheduled for elective non-cardiac, non-neurosurgical procedures;
- Consented to undergo preoperative functional status and quality of life assessments.
Exclusion criteria:
- Had severe dementia, language disorders, significant hearing or visual impairments, or were in a coma;
- Had Mini-Mental State Examination (MMSE) scores below the established educational thresholds: <18 for illiterate individuals, <21 for those with primary education (≤6 years), and <25 for those with secondary education or higher (>6 years);
- Underwent local anesthesia or monitored anesthesia care;
- Had an operative time ≤30 minutes;
- Incompleted all the designated functional status and quality of life assessments.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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A retrospective cohort study based on prospectively collected data.
Patients were divided into the MACCE group and the non-MACCE group according to the occurrence of major adverse cardiac and cerebrovascular events within 30 days after surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The primary outcome was the occurrence of MACCE within 30 days after surgery.
Time Frame: Within 30 days after surgery.
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The primary outcome was the occurrence of MACCE within 30 days after surgery, defined as any of the following: stroke, myocardial infarction, angina pectoris, congestive heart failure, cardiac arrest, or all-cause mortality.[33]
Postoperative complications were systematically assessed on days 1-5, 7, and 30, and continued until discharge.
For discharged patients, outcomes were recorded via telephone follow-up, with diagnoses from the treating hospital.
For MACCE, postoperative medical records of hospitalized patients were thoroughly reviewed according to the follow-up schedule, including serial measurements of serum myocardial injury biomarkers, electrocardiograms, echocardiograms, coronary angiography findings, postoperative progress notes, consultation records, and expert diagnostic evaluations.
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Within 30 days after surgery.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2020
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
May 31, 2022
Study Registration Dates
First Submitted
November 21, 2025
First Submitted That Met QC Criteria
November 21, 2025
First Posted (Estimated)
December 2, 2025
Study Record Updates
Last Update Posted (Estimated)
December 9, 2025
Last Update Submitted That Met QC Criteria
December 7, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLAGH - SCALE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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