Preoperative Frailty and Postoperative Prognosis in the Elderly After Major Surgeries

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04655651
Collaborator
(none)
189
1
23.4
8.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
189 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effect of Early Identification and Prehabilitation on Postoperative Prognosis in Frail Elderly Undergoing Major Surgeries
Actual Study Start Date :
Dec 20, 2020
Actual Primary Completion Date :
Feb 28, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital Beijing Beijing China

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT04655651
Other Study ID Numbers:
  • 2020.10.26
First Posted:
Dec 7, 2020
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2022