Perioperative ComplicationsNCT05387850
Clinical Frailty Assessment and Postoperative Adverse Outcomes and Quality of Life in Elderly Patients
An observational study of Perioperative Complications, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 110 years
- Conditions the study is for
- Perioperative Complications
- How many people
- 12,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2020to 30 Jan 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 to 110 years
- All sexes
- No healthy volunteers
- Older adult
Study population: hospital based group
Who may be able to join
- Geriatric surgical patients ≥65 years old
- non-selective cardiac surgery
Who cannot join
- Missing or incomplete patient follow-up records
- ASA degree V
- Delirium before surgery
- Patient refused to enroll
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Clinical Frailty Assessment With Adverse Postoperative Outcomes and Quality of Life in Elderly Non-cardiac Surgery Patients: a Prospective Study
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.
Read the 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.
- Conditions
- Perioperative Complications
- Being tested
- no intervention
- Keywords
- frailty assessment, non-cardiac surgery, Elderly patients, Adverse outcomes after surgery, Frailty scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients over the age of 65 | Elderly patients over the age of 65 undergoing elective non-cardiac surgery Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
postoperative all-cause mortality
Measured: up to 1 month
Secondary outcomes (6)
the incidence of postoperative delirium
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).
Measured: During hospitalization (up to 1 month)
postoperative sleep quality
The 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.
Measured: 6 months after surgery
anxiety state and postoperative depression state
The 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.
Measured: 12 months
postoperative quality of life evaluation
Patients'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.
Measured: 12 months
postoperative depression state (PHQ-9) Scale)
Primary 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.
Measured: 12 months
adverse postoperative outcomes
Postoperative adverse outcomes include stroke, delirium, major adverse cardiac events, pneumonia, infection, acute renal failure, etc
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start20 Sep 2020
- Primary completion30 Oct 2021
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative ComplicationsStudies 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
- Prospective
- Enrolment
- 12,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Peking University First Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Xiangya Hospital of Central South University, Beijing Anzhen Hospital, Central South University, Peking University People's Hospital, Zhejiang University, Fudan University, Sun Yat-sen University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China-Japan Friendship Hospital, The Affiliated Hospital Of Guizhou Medical University, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital of Guangxi Medical University, Taihe Hospital, Zhejiang Provincial People's Hospital, Shanghai Zhongshan Hospital
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
- Investigators
- Mi Weidong, PhD, Study chair, Chinese PLA hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387850
- Sponsor's protocol ID
- PLAGH-Frailty-001
- Status last verified
- Jun 2024
- First submitted
- 16 May 2022
- Last updated
- 10 Jun 2024
- 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 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Clinical Frailty Assessment With Adverse Postoperative Outcomes and Quality of Life in Elderly Non-cardiac Surgery Patients: a Prospective Study
- ClinicalTrials.gov ID
- NCT05387850
- Acronym / sponsor ID
- PLAGH-Frailty-001
- Conditions
- Perioperative Complications
- Keywords
- frailty assessment, non-cardiac surgery, Elderly patients, Adverse outcomes after surgery, Frailty scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,000 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Peking University First Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Xiangya Hospital of Central South University, Beijing Anzhen Hospital, Central South University, Peking University People's Hospital, Zhejiang University, Fudan University, Sun Yat-sen University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China-Japan Friendship Hospital, The Affiliated Hospital Of Guizhou Medical University, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital of Guangxi Medical University, Taihe Hospital, Zhejiang Provincial People's Hospital, Shanghai Zhongshan Hospital
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 24 May 2022 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patients over the age of 65 | – | Other: no interventionElderly patients over the age of 65 undergoing elective non-cardiac surgery |
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- hospital based group
Key inclusion criteria (2 listed)
- Geriatric surgical patients ≥65 years old
- non-selective cardiac surgery
Key exclusion criteria (4 listed)
- Missing or incomplete patient follow-up records
- ASA degree V
- Delirium before surgery
- Patient refused to enroll
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | Elderly patients over the age of 65 |
Primary outcome
mortality
Time frame: up to 1 month
postoperative all-cause mortality
6 secondary outcomes
the incidence of postoperative delirium
Time frame: During hospitalization (up to 1 month)
postoperative sleep quality
Time frame: 6 months after surgery
anxiety state and postoperative depression state
Time frame: 12 months
postoperative quality of life evaluation
Time frame: 12 months
postoperative depression state (PHQ-9) Scale)
Time frame: 12 months
adverse postoperative outcomes
Time frame: up to 1 month
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 10 Jun 2024.
- 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.
Mi Weidong, PhD study chair
Chinese PLA hospital
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 Perioperative 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 2 inclusion and 4 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 10 Jun 2024. 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?
mortality (time frame: up to 1 month). 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 10 Jun 2024.