NCT04655651

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

December 20, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

November 2, 2023

Status Verified

May 1, 2022

Enrollment Period

1.2 years

First QC Date

October 26, 2020

Last Update Submit

October 31, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • the incidence of postoperative pulmonary complications(PPCs)

    30 days after surgery

Study Arms (2)

Frailty

patients with a FRAIL Scale of 3 to 5

Other: No intervention

Non-frailty

patients with a FRAIL Scale of 0 to 2

Other: No intervention

Interventions

There is no intervention for both groups.

FrailtyNon-frailty

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Li Xu

    Peking Union Medical College Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2020

First Posted

December 7, 2020

Study Start

December 20, 2020

Primary Completion

February 28, 2022

Study Completion

August 30, 2022

Last Updated

November 2, 2023

Record last verified: 2022-05

Locations