Preoperative Frailty and Postoperative Prognosis in the Elderly After Major Surgeries

Surgery Clinical Trial

Official title:

Effect of Early Identification and Prehabilitation on Postoperative Prognosis in Frail Elderly Undergoing Major Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04655651
• Other study ID #: 2020.10.26
• Status: Completed
• Start date: December 20, 2020
• Est. completion date: August 30, 2022

Study information

• Verified date: May 2022
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 there has been no valid assessment established in China. Therefore it is important to design a research and help to solve this problem.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: August 30, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Age Problem
• Frailty
• Surgery

Intervention

Other:
• No intervention
There is no intervention for both groups.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	30 days after surgery
Secondary	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.	30 days after surgery