Preoperative Frailty and Postoperative Prognosis in the Elderly After Major Surgeries

NCT ID: NCT04655651

Last Updated: 2023-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

189 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-20

Study Completion Date

2022-08-30

Brief Summary

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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

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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

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Frailty Age Problem Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Frailty

patients with a FRAIL Scale of 3 to 5

No intervention

Intervention Type OTHER

There is no intervention for both groups.

Non-frailty

patients with a FRAIL Scale of 0 to 2

No intervention

Intervention Type OTHER

There is no intervention for both groups.

Interventions

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No intervention

There is no intervention for both groups.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Xu

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2020.10.26

Identifier Type: -

Identifier Source: org_study_id

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