## Protocol Section
### Identification Module
**NCT ID:** NCT05871879

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 202305015
#### Organization
**Class:** OTHER
**Full Name:** Taipei Medical University Hospital
### Status Module
#### Completion Date
**Date:** 2023-05-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2023-05-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-03-16

**Type:** ACTUAL

#### Start Date
**Date:** 2023-01-01

**Type:** ACTUAL

**Status Verified Date:** 2023-05

#### Study First Post Date
**Date:** 2023-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2023-05-15
**Study First Submit QC Date:** 2023-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Taipei Medical University Hospital

#### Responsible Party

**Investigator Affiliation:** Taipei Medical University Hospital

**Investigator Full Name:** Chao-Shun Lin

**Investigator Title:** Attending physician of anesthesiology, clinical professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Frailty

- Postoperative Complications

**Keywords:**

- Frailty

- Postoperative Complications

- Urologic Surgery

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 317076

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Diagnostic Test: The 5-item modified frailty index

**Label:** All adult patients who underwent urologic procedures

### Interventions

#### Intervention 1

**Arm Group Labels:**

- All adult patients who underwent urologic procedures

**Description:** 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.

**Name:** The 5-item modified frailty index

**Other Names:**

- mFI-5

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** postoperative in-hospital mortality

**Measure:** postoperative mortality

**Time Frame:** within 30 days after the primary procedure

#### Secondary Outcomes

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

**Measure:** postoperative complications

**Time Frame:** within 30 days after the primary procedure

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Surgical cases from 2015 to 2020 NSQIP dataset

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Taipei

**Country:** Taiwan

**Facility:** Taipei Medical University Hospital

**Zip:** 110

#### Overall Officials

**Official 1:**

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

**Name:** Chao-Shun Lin, PhD

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14065

- Name: Postoperative Complications

- Relevance: HIGH

- As Found: Postoperative Complications

- ID: M1175

- Name: Frailty

- Relevance: HIGH

- As Found: Frailty

### Condition Browse Module - Meshes

- ID: D000073496

- Term: Frailty

- ID: D000011183

- Term: Postoperative Complications

### Misc Info Module

- Version Holder: 2024-05-24
