Preoperative Frailty and Postoperative Prognosis in the Elderly After Major Surgeries

Completed

• Conditions: Age Problem; Frailty; Surgery
• Interventions: Other: No intervention

• Registration Number: NCT04655651
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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 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 Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-11-30
• Study First Posted: 2020-12-07
• Study Start: 2020-12-20
• Primary Completion: 2022-02-28
• Status Verified: 2022-05
• Study Completion: 2022-08-30
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Frailty	No intervention	patients with a FRAIL Scale of 3 to 5
Non-frailty	No intervention	patients with a FRAIL Scale of 0 to 2

Primary Outcome Measures

Name	Time	Method
the score of comprehensive complication index(CCI)	30 days after surgery	CCI is based on the complication grading by Clavien-Dindo Classification and can be calculated online (https://www.assessurgery.com).

Secondary Outcome Measures

Name	Time	Method
the incidence of postoperative pulmonary complications(PPCs)	30 days after surgery	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.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China