FrailtyNCT05871879
Association Between Frailty and Postoperative Adverse Outcomes in Patients Undergoing Urological Surgery
An observational study of Frailty and Postoperative Complications, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frailty, Postoperative Complications
- What is being tested?
- The 5-item modified frailty index
- How many people
- 317,076 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2023to 15 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgical cases from 2015 to 2020 NSQIP dataset
Who may be able to join
- 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.)
Who cannot join
- Incomplete information of baseline parameters
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Frailty, Postoperative Complications
- Being tested
- The 5-item modified frailty index
- Keywords
- Frailty, Postoperative Complications, Urologic Surgery
- Medical subject headings
- Frailty, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The 5-item modified frailty indexDiagnostic test
Also called mFI-5
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: The 5-item modified frailty index |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative mortality
postoperative in-hospital mortality
Measured: within 30 days after the primary procedure
Secondary outcomes (1)
postoperative complications
cardiovascular events, cerebrovascular events, pneumonia, surgical site infection, sepsis, bleeding, mechanical ventilation >48 hrs, reoperation, readmission, and length of hospital stay.
Measured: within 30 days after the primary procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start1 Jan 2023
- Primary completion16 Mar 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 317,076 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao-Shun Lin, Taipei Medical University Hospital
- Investigators
- Chao-Shun Lin, PhD, Study chair, Department of Anesthesiology, Taipei Medical University Hospital, 252 Wuxing St., Taipei 110 Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871879
- Sponsor's protocol ID
- 202305015
- Status last verified
- May 2023
- First submitted
- 15 May 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Frailty and Postoperative Adverse Outcomes in Patients Undergoing Urological Surgery
- ClinicalTrials.gov ID
- NCT05871879
- Acronym / sponsor ID
- 202305015
- Conditions
- Frailty, Postoperative Complications
- Keywords
- Frailty, Postoperative Complications, Urologic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 317,076 participants (actual)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All adult patients who underwent urologic procedures | – | Diagnostic Test: The 5-item modified frailty indexThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical cases from 2015 to 2020 NSQIP dataset
Key inclusion criteria (2 listed)
- 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.)
Key exclusion criteria (1 listed)
- Incomplete information of baseline parameters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The 5-item modified frailty indexAlso: mFI-5The 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. | Diagnostic test | All adult patients who underwent urologic procedures |
Primary outcome
postoperative mortality
Time frame: within 30 days after the primary procedure
postoperative in-hospital mortality
1 secondary outcome
postoperative complications
Time frame: within 30 days after the primary procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao-Shun Lin, PhD study chair
Department of Anesthesiology, Taipei Medical University Hospital, 252 Wuxing St., Taipei 110 Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Postoperative Complications, run by Taipei Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative mortality (time frame: within 30 days after the primary procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.