NCT05387850

Brief Summary

The frailty index may represent a useful decision support tool to optimize modifiable drivers of the quality and cost of digestive surgery care. However, classical indices are cumbersome to compute and often require unavailable data. The number of operations in the elderly is gradually increasing, and the prevention and treatment of adverse postoperative outcomes has become the focus of clinical attention. More recently, clinicians have focused more on the association between frailty and adverse postoperative outcomes, but this has not been rigorously applied to long-term prospective studies in older patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 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

Study Start

First participant enrolled

September 20, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 24, 2022

Completed
Last Updated

June 10, 2024

Status Verified

June 1, 2024

Enrollment Period

1.1 years

First QC Date

May 16, 2022

Last Update Submit

June 6, 2024

Conditions

Perioperative Complications

Keywords

frailty assessmentnon-cardiac surgeryElderly patientsAdverse outcomes after surgeryFrailty scale

Outcome Measures

Primary Outcomes (1)

  • mortality

    postoperative all-cause mortality

    up to 1 month

Secondary Outcomes (6)

  • the incidence of postoperative delirium

    During hospitalization (up to 1 month)

  • postoperative sleep quality

    6 months after surgery

  • anxiety state and postoperative depression state

    12 months

  • postoperative quality of life evaluation

    12 months

  • postoperative depression state (PHQ-9) Scale)

    12 months

  • +1 more secondary outcomes

Study Arms (1)

Elderly patients over the age of 65

Elderly patients over the age of 65 undergoing elective non-cardiac surgery

Other: no intervention

Interventions

no interventionOTHER

no intervention

Elderly patients over the age of 65

Eligibility Criteria

Age65 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hospital based group

You may qualify if:

  • Geriatric surgical patients ≥65 years old
  • non-selective cardiac surgery

You may not qualify if:

  • Missing or incomplete patient follow-up records
  • ASA degree V
  • Delirium before surgery
  • Patient refused to enroll

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Study Officials

  • Mi Weidong, PhD

    Chinese PLA hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

First Submitted

May 16, 2022

First Posted

May 24, 2022

Study Start

September 20, 2020

Primary Completion

October 30, 2021

Study Completion

January 30, 2022

Last Updated

June 10, 2024

Record last verified: 2024-06

Locations

CN(1)