Functional StatusNCT07259837
Association Between Preoperative Health and Functional Status and Postoperative Complications in Elderly Patients
An observational study of Functional Status and Postoperative Complications, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Functional Status, Postoperative Complications, Older Adults (65 Years and Older)
- How many people
- 8,751 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 31 May 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Aged ≥65 years;
- Scheduled for elective non-cardiac, non-neurosurgical procedures;
- Consented to undergo preoperative functional status and quality of life assessments.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- Functional status, Quality of life, Major Adverse Cardiac and Cerebrovascular Events, Older adults
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was the occurrence of MACCE within 30 days after surgery.
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.
Measured: Within 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Apr 2020
- Primary completion30 Apr 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional StatusStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- 8,751 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Liu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259837
- Sponsor's protocol ID
- PLAGH - SCALE
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 9 Dec 2025
- 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 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Preoperative Health and Functional Status and Postoperative Complications in Elderly Patients: An Analysis of a Prospective Cohort
- ClinicalTrials.gov ID
- NCT07259837
- Acronym / sponsor ID
- PLAGH - SCALE
- Keywords
- Functional status, Quality of life, Major Adverse Cardiac and Cerebrovascular Events, Older adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,751 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 2 Dec 2025 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- Aged ≥65 years;
- Scheduled for elective non-cardiac, non-neurosurgical procedures;
- Consented to undergo preoperative functional status and quality of life assessments.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome was the occurrence of MACCE within 30 days after surgery.
Time frame: Within 30 days after surgery.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Functional Status and Postoperative Complications, run by Chinese PLA General Hospital 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 3 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: finished, as of the sponsor's last update on 9 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was the occurrence of MACCE within 30 days after surgery. (time frame: Within 30 days after surgery.). 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 9 Dec 2025.