Association Between Frailty and Postoperative Adverse Outcomes in Patients Undergoing Urological Surgery

Sponsor
Taipei Medical University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05871879
Collaborator
(none)
317,076
1
4.4
72022.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: The 5-item modified frailty index

Detailed Description

Frailty is a clinical condition that often develops with age and is characterized by a decline in physiological capacity and dysfunction across multiple organ systems. This decline results in reduced physical reserve and an increased vulnerability to acute stressors, such as surgical interventions. The prevalence of frailty varies based on the definition used, with 15% of the nonnursing home population in the US experiencing frailty and 45% experiencing prefrailty. Frailty is more common in individuals with certain comorbidities, such as HIV infection, chronic obstructive pulmonary disease, and end-stage renal disease, and it is more prevalent with increasing age.

Previous studies have established a link between urologic issues and frailty. In fact, more than 40% of patients with lower urologic symptoms exhibit frailty-related features such as sarcopenia, dysmotility, multimorbidity, and a heightened risk of malnutrition. Additionally, common geriatric ailments, such as benign prostate hypertrophy, dementia, spinal disc herniation, and cerebral infarction, are also associated with neurogenic bladder and other voiding difficulties. Consequently, surgical intervention is often necessary for these populations. However, even minimally invasive procedures may be risky due to the vulnerability of frail individuals. Prior studies have shown a strong correlation between frailty and the likelihood of postoperative mortality and morbidity. Patients classified as very frail have 30-day and 180-day mortality rates of approximately 10% and 40%, respectively, even following minor surgeries.

A new tool for assessing frailty, the 5-item modified frailty index (mFI-5), has recently been developed using data from the National Surgical Quality Improvement Program (NSQIP) database. This simplified scale, which consists of only five items, has demonstrated superior predictive ability compared to previously utilized tools. The mFI-5 has been studied across various surgical populations and has been found to be associated with unfavorable postoperative outcomes. However, there are limited studies examining its utility in urologic surgery, and no reports has investigated the association between frailty and minimally invasive urologic procedures. Therefore, the present study aimed to investigate the correlation between the modified 5-item frailty index and postoperative mortality and complications among frail patients who undergo urologic surgery.

Study Design

Study Type:
Observational
Actual Enrollment :
317076 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Association Between Frailty and Postoperative Adverse Outcomes in Patients Undergoing Urological Surgery
Actual Study Start Date :
Jan 1, 2023
Actual Primary Completion Date :
Mar 16, 2023
Actual Study Completion Date :
May 15, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.
Other Names:
  • mFI-5
  • Outcome Measures

    Primary Outcome Measures

    1. postoperative mortality [within 30 days after the primary procedure]

      postoperative in-hospital mortality

    Secondary Outcome Measures

    1. postoperative complications [within 30 days after the primary procedure]

      cardiovascular events, cerebrovascular events, pneumonia, surgical site infection, sepsis, bleeding, mechanical ventilation >48 hrs, reoperation, readmission, and length of hospital stay.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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.)

    Exclusion Criteria:
    • Incomplete information of baseline parameters

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Taipei Medical University Hospital Taipei Taiwan 110

    Sponsors and Collaborators

    • Taipei Medical University Hospital

    Investigators

    • Study Chair: Chao-Shun Lin, PhD, Department of Anesthesiology, Taipei Medical University Hospital, 252 Wuxing St., Taipei 110 Taiwan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chao-Shun Lin, Attending physician of anesthesiology, clinical professor, Taipei Medical University Hospital
    ClinicalTrials.gov Identifier:
    NCT05871879
    Other Study ID Numbers:
    • 202305015
    First Posted:
    May 23, 2023
    Last Update Posted:
    May 23, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chao-Shun Lin, Attending physician of anesthesiology, clinical professor, Taipei Medical University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 23, 2023