NCT05871879

Brief Summary

Frailty is a clinical condition associated with aging that is characterized by a decline in physiological capacity involving multiple organ systems. Previous research has established a strong correlation between frailty and increased mortality and morbidity risk after surgery. The 5-item modified frailty index (mFI-5) is a recent tool used to assess frailty. The aim of the present study was to use the mFI-5 to identify frailty and its association with postoperative adverse outcomes, including mortality and morbidity, among patients who underwent urologic procedures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
317,076

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

May 15, 2023

Last Update Submit

May 15, 2023

Conditions

Keywords

FrailtyPostoperative ComplicationsUrologic Surgery

Outcome Measures

Primary Outcomes (1)

  • postoperative mortality

    postoperative in-hospital mortality

    within 30 days after the primary procedure

Secondary Outcomes (1)

  • postoperative complications

    within 30 days after the primary procedure

Study Arms (1)

All adult patients who underwent urologic procedures

The included procedures included all urologic oncology surgeries, suburethral sling placement, laparoscopic pyeloplasty, transurethral resection of the prostate, transurethral resection of the bladder tumor, ureteroscopy, hydrocelectomy, orchiectomy, spermatocelectomy, epididymectomy, and varicocelectomy.

Diagnostic Test: The 5-item modified frailty index

Interventions

The mFI-5 contains five items, including hypertension, diabetes, congestive heart failure (CHF), chronic obstructive lung disease (COPD), and physical function status, with each item attributing 1 point. Patients with an mFI-5 score greater than or equal to 2 were considered frail, while those with an mFI-5 score of 0 or 1 were considered nonfrail.

Also known as: mFI-5
All adult patients who underwent urologic procedures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgical cases from 2015 to 2020 NSQIP dataset

You may qualify if:

  • All adult patients who underwent urologic procedures were recruited
  • (Included procedures : all urologic oncology surgeries, suburethral sling placement and laparoscopic pyeloplasty, transurethral resection of the prostate, transurethral resection of the bladder tumor, ureteroscopy, hydrocelectomy, orchiectomy, spermatocelectomy, epididymectomy, and varicocelectomy.)

You may not qualify if:

  • Incomplete information of baseline parameters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

FrailtyPostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chao-Shun Lin, PhD

    Department of Anesthesiology, Taipei Medical University Hospital, 252 Wuxing St., Taipei 110 Taiwan

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician of anesthesiology, clinical professor

Study Record Dates

First Submitted

May 15, 2023

First Posted

May 23, 2023

Study Start

January 1, 2023

Primary Completion

March 16, 2023

Study Completion

May 15, 2023

Last Updated

May 23, 2023

Record last verified: 2023-05

Locations