Clinical Trial

Anesthesia Type and HoLEP Outcomes: A Multi-Center Study

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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.
Trial Details
NCT Number NCT07585552
Lead Sponsor Ondokuz Mayıs University
Conditions Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms
Enrollment 320 participants
Start Date 2026-04-23
Primary Completion 2027-08-01 (estimated)
Study Completion 2027-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-13