FrailtyNCT04655651
Preoperative Frailty and Postoperative Prognosis in the Elderly After Major Surgeries
An observational study of Frailty and Age Problem, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Elderly people often have comorbidities. However, there could be a big difference in their health status. Frailty is considered to be relevant to adverse outcomes. Some studies have found that preoperative frailty assessment and comprehensive geriatric assessment (CGA) of the elderly can improve clinical outcomes, but… Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Frailty, Age Problem, Surgery
- How many people
- 189 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2020to 30 Aug 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 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients over 65 years old who are scheduled for elective major surgery under general anesthesia in Peking Union Medical College Hospital
Who may be able to join
- Aging at least 65 years old.
- Scheduled for major surgery in Peking Union Medical College Hospital .
- Understand and be willing to participate in this research, and can provide written informed consent.
Who cannot join
- Underwent major surgery within the last month.
- Can't complete the scale evaluation because of lower limb disability or severe knee osteoarthritis and other conditions that affect walking or climbing stairs.
- With mental or neurological disorders and unable to cooperative with investigators.
- Reject to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Early Identification and Prehabilitation on Postoperative Prognosis in Frail Elderly Undergoing Major Surgeries
Elderly people often have comorbidities. However, there could be a big difference in their health status. Frailty is considered to be relevant to adverse outcomes. Some studies have found that preoperative frailty assessment and comprehensive geriatric assessment (CGA) of the elderly can improve clinical outcomes, but there has been no valid assessment established in China. Therefore it is important to design a research and help to solve this problem.
Read the detailed description
With an aging population and the improvement of medical technology, the number of elderly patients who need surgery is gradually increasing. Elderly people often have comorbidities, malnutrition, and other conditions leading to an increased risk of anesthesia. What's more, there could be a big difference in the health status of the elderly with the same age. Frailty is considered to be highly prevalent with increasing age and to confer high risk for adverse outcomes. A complete evaluation of elderly patients before surgery may help improve the prognosis. Some studies have found that preoperative frailty assessment and comprehensive geriatric assessment (CGA) of the elderly can improve clinical outcomes, but there has been no valid assessment established in China. In this study, we plan to use a comprehensive preoperative frailty assessment and follow up for 30 days after surgery to explore the effect of preoperative frailty on postoperative complications in the elderly after major surgeries. To better evaluate the postoperative complications, we choose comprehensive complication index (CCI), which integrates all complication of the Clavien-Dindo classification and offers a metric approach to measure morbidity.
- Conditions
- Frailty, Age Problem, Surgery
- Being tested
- No intervention
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention for both groups.
| Study group | Role | What they receive |
|---|---|---|
| Frailty | patients with a FRAIL Scale of 3 to 5 Receives: Other: No intervention | |
| Non-frailty | patients with a FRAIL Scale of 0 to 2 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the score of comprehensive complication index(CCI)
CCI is based on the complication grading by Clavien-Dindo Classification and can be calculated online (https://www.assessurgery.com).
Measured: 30 days after surgery
Secondary outcomes (1)
the incidence of postoperative pulmonary complications(PPCs)
PPCs are a comprehensive evaluation of pulmonary complications. PPCs conclude respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, pneumonia, acute respiratory distress syndrome (ARDS), tracheobronchitis, pulmonary oedema, exacerbation of pre-existing lung disease, pulmonary embolus and death.
Measured: 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 posted7 Dec 2020
- Study start20 Dec 2020
- Primary completion28 Feb 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Xu, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655651
- Sponsor's protocol ID
- 2020.10.26
- Status last verified
- May 2022
- First submitted
- 26 Oct 2020
- Last updated
- 2 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This study will include preoperative evaluations of the elderly scheduled for major surgery. If required, the data could be shared to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Identification and Prehabilitation on Postoperative Prognosis in Frail Elderly Undergoing Major Surgeries
- ClinicalTrials.gov ID
- NCT04655651
- Acronym / sponsor ID
- 2020.10.26
- Conditions
- Frailty, Age Problem, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 7 Dec 2020 (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.
Elderly people often have comorbidities. However, there could be a big difference in their health status. Frailty is considered to be relevant to adverse outcomes. Some studies have found that preoperative frailty assessment and comprehensive geriatric assessment (CGA) of the elderly can improve clinical outcomes, but there has been no valid assessment established in China. Therefore it is important to design a research and help to solve this problem.
Detailed description
With an aging population and the improvement of medical technology, the number of elderly patients who need surgery is gradually increasing. Elderly people often have comorbidities, malnutrition, and other conditions leading to an increased risk of anesthesia. What's more, there could be a big difference in the health status of the elderly with the same age. Frailty is considered to be highly prevalent with increasing age and to confer high risk for adverse outcomes. A complete evaluation of elderly patients before surgery may help improve the prognosis. Some studies have found that preoperative frailty assessment and comprehensive geriatric assessment (CGA) of the elderly can improve clinical outcomes, but there has been no valid assessment established in China. In this study, we plan to use a comprehensive preoperative frailty assessment and follow up for 30 days after surgery to explore the effect of preoperative frailty on postoperative complications in the elderly after major surgeries. To better evaluate the postoperative complications, we choose comprehensive complication index (CCI), which integrates all complication of the Clavien-Dindo classification and offers a metric approach to measure morbidity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frailty | – | Other: No interventionpatients with a FRAIL Scale of 3 to 5 |
| Non-frailty | – | Other: No interventionpatients with a FRAIL Scale of 0 to 2 |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients over 65 years old who are scheduled for elective major surgery under general anesthesia in Peking Union Medical College Hospital
Key inclusion criteria (3 listed)
- Aging at least 65 years old.
- Scheduled for major surgery in Peking Union Medical College Hospital .
- Understand and be willing to participate in this research, and can provide written informed consent.
Key exclusion criteria (4 listed)
- Underwent major surgery within the last month.
- Can't complete the scale evaluation because of lower limb disability or severe knee osteoarthritis and other conditions that affect walking or climbing stairs.
- With mental or neurological disorders and unable to cooperative with investigators.
- Reject to sign the informed consent.
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 interventionThere is no intervention for both groups. | Other | Frailty, Non-frailty |
Primary outcome
the score of comprehensive complication index(CCI)
Time frame: 30 days after surgery
CCI is based on the complication grading by Clavien-Dindo Classification and can be calculated online (https://www.assessurgery.com).
1 secondary outcome
the incidence of postoperative pulmonary complications(PPCs)
Time frame: 30 days after surgery
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 2 Nov 2023.
- Individual participant dataSharing planned: Undecided. This study will include preoperative evaluations of the elderly scheduled for major surgery. If required, the data could be shared to other researchers.
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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.
Li Xu study chair
Peking Union Medical College 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 Frailty and Age Problem, run by Peking Union Medical College 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 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 2 Nov 2023. 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 score of comprehensive complication index(CCI) (time frame: 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 2 Nov 2023.