NCT06182228

Brief Summary

The effectiveness of assessing postoperative outcomes in eldely patients undergoing major abdominal surgery through the Frailty Scale and Katz Activities of Daily Living evaluation is investigated in individuals aged 65-85. The secondary objective is to determine the prevalence of frailty in patients undergoing surgical procedures.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

June 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 26, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

Same day

First QC Date

November 15, 2023

Last Update Submit

February 13, 2024

Conditions

Keywords

Surgical patient

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of the FRAIL scale in predicting postoperative outcomes

    5 questions of the FRAIL Scale were asked.Questions that evaluated fatigue(How tired have you felt in the last 4 weeks?),resistance(Do you have difficulty climbing 10 flights of stairs on your own, without using any assistive devices, without resting?), wandering (Do you have difficulty walking a few hundred meters on your own and without using an assistive device?), diseases ( How many of the 11 diseases we will list have been told to you by a doctor before as your "disease"? Hypertension, diabetes, cancer (other than minor skin cancer), chronic lung disease, myocardial infarction, congestive heart failure, angina, asthma, arthritis, kidney disease and stroke) and unintentional weight loss (Have you lost 5% of your body weight in the last year?) were given "0" and "1" points. At the end of a total of 5 questions, those who scored 0 points were considered "non-frail", those who scored 1-2 points were considered "pre-frail", and those who scored 3-5 points were considered "frail".

    1 month

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 65-85 who underwent major abdominal surgery

You may qualify if:

  • Being between the ages of 65-85
  • Patients requiring elective major abdominal surgery
  • Approval of the informed consent form

You may not qualify if:

  • Those under the age of 65 and over the age of 85
  • Those with cognitive dysfunction
  • Those who did not approve of participating in the study
  • Patients requiring urgent surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uludag Universty

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2023

First Posted

December 26, 2023

Study Start

June 1, 2022

Primary Completion

June 1, 2022

Study Completion

March 30, 2024

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

I have not decided

Locations