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Clinical Frailty Assessment and Postoperative Adverse Outcomes and Quality of Life in Elderly Patients

Association of Clinical Frailty Assessment With Adverse Postoperative Outcomes and Quality of Life in Elderly Non-cardiac Surgery Patients: a Prospective Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05387850
Enrollment
12000
Registered
2022-05-24
Start date
2020-09-20
Completion date
2022-01-30
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Complications

Keywords

frailty assessment, non-cardiac surgery, Elderly patients, Adverse outcomes after surgery, Frailty scale

Brief summary

The frailty index may represent a useful decision support tool to optimize modifiable drivers of the quality and cost of digestive surgery care. However, classical indices are cumbersome to compute and often require unavailable data. The number of operations in the elderly is gradually increasing, and the prevention and treatment of adverse postoperative outcomes has become the focus of clinical attention. More recently, clinicians have focused more on the association between frailty and adverse postoperative outcomes, but this has not been rigorously applied to long-term prospective studies in older patients.

Detailed description

As the population aging is speeding up, senile diseases have become a significant and severe public health problem, influencing national health. More than 20 million elderly patients undergo surgery each year in China, accounting for a quarter of the population who undergo surgery. Advanced age and comorbid diseases render the elderly at increased risk of postoperative morbidity and mortality. The incidence of postoperative complications is twice as non-elderly patients, and mortality rates are five times higher than non elderly patients. Thus, it is a significant challenge to safely and stably ensure the elderly in an optimal perioperative period. Elderly patients continue to pose a major threat to the world's rapidly ageing population due to high rates of surgery and postoperative complications in elderly patients. Therefore, optimizing perioperative management strategies for elderly patients remains one of the biggest challenges facing clinicians. Frailty is a multidimensional clinical syndrome characterized by vulnerability to dependence and increased mortality when exposed to stressors. It is often clinically described as a lack of physiological reserve, manifested as a loss of physical ability, metabolic function, and cognitive abilities. A systematic review of studies of patients in general surgery reported that the prevalence of prefrailty was estimated to be between 11.3% and 45.8%, while the prevalence of frailty was estimated to be between 10.4% and 37.0%. Although clinicians or relatives may be aware of frailty, there is currently no standardized clinical gold-standard assessment tool to widely use and quantify frailty.

Interventions

OTHERno intervention

no intervention

Sponsors

Beijing Tiantan Hospital
CollaboratorOTHER
Peking University First Hospital
CollaboratorOTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
CollaboratorOTHER
Xiangya Hospital of Central South University
CollaboratorOTHER
Beijing Anzhen Hospital
CollaboratorOTHER
Central South University
CollaboratorOTHER
Peking University People's Hospital
CollaboratorOTHER
Zhejiang University
CollaboratorOTHER
Fudan University
CollaboratorOTHER
Sun Yat-sen University
CollaboratorOTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
CollaboratorOTHER
China-Japan Friendship Hospital
CollaboratorOTHER
The Affiliated Hospital Of Guizhou Medical University
CollaboratorOTHER
First Affiliated Hospital of Xinjiang Medical University
CollaboratorOTHER
First Affiliated Hospital of Guangxi Medical University
CollaboratorOTHER
Taihe Hospital
CollaboratorOTHER
Zhejiang Provincial People's Hospital
CollaboratorOTHER
Shanghai Zhongshan Hospital
CollaboratorOTHER
Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to 110 Years
Healthy volunteers
No

Inclusion criteria

* Geriatric surgical patients ≥65 years old * non-selective cardiac surgery

Exclusion criteria

* Missing or incomplete patient follow-up records * ASA degree V * Delirium before surgery * Patient refused to enroll

Design outcomes

Primary

MeasureTime frameDescription
mortalityup to 1 monthpostoperative all-cause mortality

Secondary

MeasureTime frameDescription
postoperative sleep quality6 months after surgeryThe PSQI measures sleep quality retrospectively over the previous month using self-report/recall; it consists of nineteen individual items which evaluate the seven components of sleep quality: (1) sleep duration; (2) sleep disturbance; (3) sleep latency; (4) daytime dysfunction due to sleepiness; (5) sleep efficiency; (6) overall sleep quality; and (7) sleep medication usageThese seven component scores (scored 0-3) are added together to yield one global score between 0-21, with higher scores indicating worse sleep quality . A global PSQI score ≤5 indicates good sleep quality and \>5 indicates poor sleep quality.
anxiety state and postoperative depression state12 monthsThe GAD-7 asks how often people have suffered from the seven core symptoms of GAD within the last two weeks with the response options being 'not at all', 'on some days', 'on more than half of the days' and 'almost every day' (scored 0-3, with a total score ranging from 0 to 21) . The GAD-7 has been validated within a large sample of patients in a primary care setting, and within a large general population sample in Germany.The higher the score, the worse the situation.
the incidence of postoperative deliriumDuring hospitalization (up to 1 month)the incidence of postoperative delirium (3D-CAM scale).Delirium was defined as acute, transient, fluctuating, and usually reversible disturbances in attention, cognition, or attention level. It was assessed every 12 hours by trained nurses using the confusion assessment method (CAM).
postoperative depression state (PHQ-9) Scale)12 monthsPrimary outcomes were depression (Patient Health Questionnaire 9 (PHQ-9)).Depression was evaluated using the Chinese version of the patient health questionnaire (PHQ-9), which has nine items measuring self-assessed depressive symptoms experienced during the previous 2 weeks. It uses a 4-point Likert-type scale (0 = never, 1 = sometimes, 2 = more than once a week, and 3 = almost every day). The total score ranges from 0 to 27, and higher scores indicate more depressive symptoms. Scores of 10 and 15 represent cutpoints for moderate and moderately severe depression, respectively. The Chinese version of the PHQ-9 has shown good psychometric properties with reported Cronbach's α of 0.86.
adverse postoperative outcomesup to 1 monthPostoperative adverse outcomes include stroke, delirium, major adverse cardiac events, pneumonia, infection, acute renal failure, etc
postoperative quality of life evaluation12 monthsPatients'quality of life was assessed through telephone interviews 12 months after surgery using the EQ5D. EQ5D is a measure of health status, assessing daily activities, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension consists of a 3-level response: no problems, moderate problems, or severe problems. A scoring algorithm is available by which each health status description can be expressed as an overall score using the published Chinese tariffs for the Chinese population,12 ranging from 0 (death) to 1 (full health). EQ5Dquestionnaires were acquired according to the script for telephone administration of the EQ5D5L simplified Chinese version for China through telephone interviews 12 months after surgery.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026