Anesthesia Type and HoLEP Outcomes: A Multi-Center Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorOndokuz Mayıs University

About this trial

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.

Eligibility criteria

Qualifiers

18 years or older men who have BPO requiring surgical treatment.

Participants who can give written informed consent.

Having no more than 3 points for the American Society of Anesthesiologists (ASA) physical status classification scale (ASA 1 to 3).

Disqualifiers

Absolute contraindication for spinal or general anesthesia

History of previous surgery for prostate (e.g., surgery for prostate cancer, surgery for benign prostate obstruction)

Uncorrected bleeding disorder (INR > 1.5)

Participants who are not willing to give informed consent.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

320 Participants
are grouped into 2 trial groups

Sponsors and collaborators