Clinical trial NCT05871879: Association Between Frailty and Postoperative Adverse Outcomes in Patients Undergoing Urological Surgery
Official title: Association Between Frailty and Postoperative Adverse Outcomes in Patients Undergoing Urological Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Postoperative Complications
Keywords: Frailty
Postoperative Complications
Urologic Surgery
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 317076
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical cases from 2015 to 2020 NSQIP dataset

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: postoperative mortality
timeFrame: within 30 days after the primary procedure
Secondary outcomes:
measure: postoperative complications
timeFrame: within 30 days after the primary procedure
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Department of Anesthesiology, Taipei Medical University Hospital, 252 Wuxing St., Taipei 110 Taiwan
name: Chao-Shun Lin, PhD
role: STUDY_CHAIR
References: