Clinical trial NCT05387850: Clinical Frailty Assessment and Postoperative Adverse Outcomes and Quality of Life in Elderly Patients
Official title: Association of Clinical Frailty Assessment With Adverse Postoperative Outcomes and Quality of Life in Elderly Non-cardiac Surgery Patients: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative Complications
Keywords: frailty assessment
non-cardiac surgery
Elderly patients
Adverse outcomes after surgery
Frailty scale
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Peking University First Hospital
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Xiangya Hospital of Central South University
name: Beijing Anzhen Hospital
name: Central South University
name: Peking University People's Hospital
name: Zhejiang University
name: Fudan University
name: Sun Yat-sen University
name: Wuhan Union Hospital, China
name: China-Japan Friendship Hospital
name: The Affiliated Hospital Of Guizhou Medical University
name: First Affiliated Hospital of Xinjiang Medical University
name: First Affiliated Hospital of Guangxi Medical University
name: Taihe Hospital
name: Zhejiang Provincial People's Hospital
name: Shanghai Zhongshan Hospital
First posted: 2022-05-24
Enrollment: 12000
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital based group

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.

Eligibility criteria: 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

Primary outcomes:
measure: mortality
timeFrame: up to 1 month
Secondary outcomes:
measure: the incidence of postoperative delirium
timeFrame: During hospitalization (up to 1 month)
measure: postoperative sleep quality
timeFrame: 6 months after surgery
measure: anxiety state and postoperative depression state
timeFrame: 12 months
measure: postoperative quality of life evaluation
timeFrame: 12 months
measure: postoperative depression state (PHQ-9) Scale)
timeFrame: 12 months
measure: adverse postoperative outcomes
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA hospital
name: Mi Weidong, PhD
role: STUDY_CHAIR
References: