Clinical trial NCT04655651: Preoperative Frailty and Postoperative Prognosis in the Elderly After Major Surgeries
Official title: Effect of Early Identification and Prehabilitation on Postoperative Prognosis in Frail Elderly Undergoing Major Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Age Problem
Surgery
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 189
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the score of comprehensive complication index(CCI)
timeFrame: 30 days after surgery
Secondary outcomes:
measure: the incidence of postoperative pulmonary complications(PPCs)
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Li Xu
role: STUDY_CHAIR
References: