Ondokuz Mayis University, Faculty of Medicine, Department of Urology
Samsun, Turkey (Türkiye)
NCT Number: NCT07585552
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 opening soon.
Get Notified18 year and older
Male
Observational
Samsun, Turkey (Türkiye)
Benign prostatic obstruction (BPO) is the leading cause of lower urinary tract symptoms (LUTS) among men older than 40 years.
Surgery is recommended under circumstances such as:
Various surgical methods exist to treat BPO, but the most appropriate choice depends on the operator and the patient.
HoLEP is an abbreviation for holmium laser enucleation of prostate, which is one of the endoscopic laser enucleation techniques.
Both spinal and general anesthesia are applicable for HoLEP surgery. The type of anesthesia is determined by the anesthesiologist, independently of the operator's preference, taking into account several factors related to the patient, such as safety and comfort.
Controlled bleeding is one of the expected outcomes in HoLEP, and several factors determine the amount of bleeding. For HoLEP, the type of anesthesia may be one of them, as other studies have claimed. This multicenter, prospective observational study may further reveal the impact of anesthesia type on bleeding.
The amount of bleeding could be "less or more", determined according to the content below:
Participants who are eligible and willing to provide informed consent will undergo HoLEP. Preoperative, perioperative, and postoperative data will be collected without disclosing the participant or any personal data relating to the participant.
Participants will be grouped into two groups based on anesthesia type: general or spinal.
To answer the main question of this study, a power analysis was conducted, concluding that at least 320 participants are required (intention-to-treat population).
All collected data will be recorded and analyzed according to the proper statistical methods. Results will be reported.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: First day after HoLEP is performed.
Difference between preoperative and postoperative hemoglobin levels (g/dL)
Time frame: At 3 months after HoLEP
The severity of lower urinary tract symptoms and their impact on quality of life should be assessed using a validated questionnaire.
Time frame: Postoperative second to seventh days after HoLEP.
Day(s) passed until discharge after HoLEP.
Time frame: From the time of HoLEP until the removal of the catheter.
Day(s) passed until the removal of the bladder drainage catheter after HoLEP.
Time frame: From the time of HoLEP to 30 days after HoLEP.
Complications will be classified according to the Clavien-Dindo classification. Clavien-Dindo Grade III or higher is considered a high-grade complication.
Time frame: At 3 months after HoLEP.
Peak urinary flow (mL/sec), at 3 months after HoLEP.
Time frame: At 3 months after HoLEP
Post-void residual (PVR) volume (mL) measurement at 3 months after HoLEP
Time frame: From the start of HoLEP to the end of HoLEP (Operative time).
Weight of the enucleated adenoma per operative minute (grams/min).
Time frame: During the anesthesia for HoLEP
Number of participants who required vasoactive medication during anesthesia for HoLEP due to low blood pressure, as a percentage of the total number of participants.
Contact information is provided by the study sponsor or research team.
Ondokuz Mayıs University
Other
Does Anesthesia Type Affect HoLEP Outcomes? A Multi-Center, Real-World Comparative Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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