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NCT07585552

Anesthesia Type and HoLEP Outcomes: A Multi-Center Study

Sponsor: Ondokuz Mayıs University

View on ClinicalTrials.gov

Summary

1. What is this study about, and why is it required? The goal of this observational study is to learn if anesthesia type (e.g., general anesthesia, spinal anesthesia) affects the safety and efficiency of HoLEP surgery. The main question it aims to answer is: \- Is a particular type of anesthesia related to less or more bleeding during the surgery? 2. What will be assessed to answer the main question of this study? (Outcome measure(s)) 2.1. Primary outcome measure of this study is: \- Change in the hemoglobin level perioperatively. 2.2. Secondary outcome measures are: * Requirement for the usage of any vasoactive medication due to low blood pressure * Time passed until discharge. * Time passed until the removal of the bladder drainage catheter. * Ratio of the unwanted events that require additional intervention other than medication, fluids, or blood transfusions (Complications, Clavien-Dindo Grade III or higher). * International symptom questionnaire score 3 months after surgery. * Quality of life (QoL) score 3 months after surgery. * Peak urinary current velocity (Qmax) and post-void residual volume measurement 3 months after surgery. 3. Can anyone participate in this study? Voluntary participants should meet the following criteria: * Being older than 18 years old. * Having bothersome lower urinary tract symptoms due to prostatic enlargement requiring surgical treatment. * Having no untreated or uncontrolled systemic disease, which refers to having an ASA (American Society of Anesthesiologists Physical Status Classification System) score III at most.

Official title: Does Anesthesia Type Affect HoLEP Outcomes? A Multi-Center, Real-World Comparative Study

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

320

Start Date

2026-04-23

Completion Date

2027-09-01

Last Updated

2026-05-13

Healthy Volunteers

No

Locations (1)

Ondokuz Mayis University, Faculty of Medicine, Department of Urology

Samsun, Turkey (Türkiye)