NCT06522178

Brief Summary

Average life span, life expectancy, and the number of older people, aged 65 years and over, have increased during the last decades. As life expectancy increased, the rate of emergency and elective surgical interventions has also increased in the older age group. Although good health is required to reach an advanced age, over time, organ functions may deteriorate, and some challenges may develop that will negatively affect the balance of homeostasis. Stress, such as trauma or surgery, can cause deterioration in organ functions or aggravation of impaired functions. The risk of developing undesirable events is higher, due to the diminished reserve and function, during anesthesia applied to these patients. There is a limited number of studies in the literature about the relation between the anesthesia technique and morbidity and mortality in oldest old patients operated for orthopedic surgery. In this study, we aimed to analyze the data of the oldest-old patients operated on for orthopedic surgery between 2016-2022, retrospectively, and to investigate the relationship between anesthesia technique and adverse effects including morbidity and mortality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,356

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2016

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2024

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

7 years

First QC Date

July 22, 2024

Last Update Submit

July 22, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Mortality

    postoperative mortality

    one month after operation

  • Anesthesia Techniques

    Data were also analyzed and compared with groups and between groups according to the applied anesthesia technique (general anesthesia versus regional anesthesia).

    up to 6 hours

  • Type of operation

    Orthopedic surgery type

    up to 6 hours

Secondary Outcomes (1)

  • Presence and type of comorbidities

    6 month period before operation

Study Arms (2)

Group 1

Group I patients contained those who were between 80 (included) and 89 (included) years of age.

Other: Patient' ages

Group 2

Those who were 90 years of age and above were included in Group II

Other: Patient' ages

Interventions

Patients were divided into two groups according to their ages.

Group 1Group 2

Eligibility Criteria

Age80 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 1356 oldest-old patients underwent orthopedic surgery between January 02 2016 and December 31 2022 in our hospital.

You may qualify if:

  • Aged 80 years and above
  • Underwent orthopedic surgery

You may not qualify if:

  • Those who had the operation with local anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University

Istanbul, 34730, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass-Prof

Study Record Dates

First Submitted

July 22, 2024

First Posted

July 26, 2024

Study Start

January 3, 2016

Primary Completion

December 31, 2022

Study Completion

January 1, 2024

Last Updated

July 26, 2024

Record last verified: 2024-07

Locations