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Anesthesia Type and HoLEP Outcomes: A Multi-Center Study

NCT07585552 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 320

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms

Sponsors & Collaborators

  • Ondokuz Mayıs University

    lead OTHER

Principal Investigators

  • Murat Gulsen · Ondokuz Mayıs University

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-23
Primary Completion
2027-08-01
Completion
2027-09-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07585552 on ClinicalTrials.gov