- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05871879
Association Between Frailty and Postoperative Adverse Outcomes in Patients Undergoing Urological Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan, 110
- Taipei Medical University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative mortality
Time Frame: within 30 days after the primary procedure
|
postoperative in-hospital mortality
|
within 30 days after the primary procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative complications
Time Frame: 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.
|
within 30 days after the primary procedure
|
Collaborators and Investigators
Investigators
- Study Chair: Chao-Shun Lin, PhD, Department of Anesthesiology, Taipei Medical University Hospital, 252 Wuxing St., Taipei 110 Taiwan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202305015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Complications
-
Twin Cities Spine CenterAllina Health SystemRecruitingComplications, PostoperativeUnited States
-
Marmara UniversityHacettepe University; Cukurova University; Gazi University; Baskent University; Istanbul... and other collaboratorsNot yet recruitingComplications, PostoperativeTurkey
-
Syed HusainCompletedComplications, PostoperativeUnited States
-
Yale UniversityRecruitingPostoperative Complications (Cardiopulmonary)United States
-
Washington University School of MedicineNational Institute of Nursing Research (NINR)CompletedSurgery | Surgery--Complications | Perioperative/Postoperative ComplicationsUnited States
-
Vastra Gotaland RegionRecruitingSurgery | Lung Infection | Complications, PostoperativeSweden
-
University of PittsburghCompletedLiver Transplant; Complications | Perioperative/Postoperative ComplicationsUnited States
-
Chi Mei Medical HospitalCompletedPostoperative Respiratory Complications | Pain, Postoperative.Taiwan
-
Fujian Medical University Union HospitalNot yet recruitingPostoperative Pulmonary Complications
-
COPAL - My JourneyRecruiting
Clinical Trials on The 5-item modified frailty index
-
Song Cheol KimCompletedPostoperative ComplicationKorea, Republic of
-
Diskapi Yildirim Beyazit Education and Research...Recruiting
-
Atatürk Chest Diseases and Chest Surgery Training...Not yet recruitingLung Cancer | Complication,PostoperativeTurkey
-
Beijing Tsinghua Chang Gung HospitalRecruitingPostoperative Complications | Cerebrovascular Accident | Major Adverse Cardiac Events | ModelsChina
-
Ankara Ataturk Sanatorium Training and Research...CompletedElderly Patients | Sedation Complication | Monitored Anesthesia Care | EBUS Guided Transbronchial Needle AspirationTurkey
-
Second Affiliated Hospital, School of Medicine,...CompletedAcute Ischemic Stroke | NursingChina
-
Cigdem CinarCompletedLower Limb AmputationTurkey
-
Assiut UniversityCompletedInflammatory Bowel Diseases | Sexual Function DisturbancesEgypt
-
Radboud University Medical CenterRecruitingPediatric Anesthesia | Anesthesia | Nociceptive Pain | Nociception MonitoringNetherlands