Preoperative Frailty and Postoperative Prognosis in the Elderly After Major Surgeries

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.

Study Overview

• Status: Completed
• Conditions: Frailty; Surgery; Age Problem
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Actual): 189

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients over 65 years old who are scheduled for elective major surgery under general anesthesia in Peking Union Medical College Hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Frailty; patients with a FRAIL Scale of 3 to 5	Other: No intervention; There is no intervention for both groups.
Non-frailty; patients with a FRAIL Scale of 0 to 2	Other: No intervention; There is no intervention for both groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Chair: Li Xu, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2020
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 2020.10.26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This study will include preoperative evaluations of the elderly scheduled for major surgery. If required, the data could be shared to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No