Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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?
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:
Can anyone participate in this study?
Voluntary participants should meet the following criteria:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Anesthesia | Participants undergoing HoLEP under general anesthesia (intubation or laryngeal mask airway) | ||
| Spinal Anesthesia | Participants undergoing HoLEP under spinal anesthesia |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin change | Difference between preoperative and postoperative hemoglobin levels (g/dL) | First day after HoLEP is performed. |
| Measure | Description | Time Frame |
|---|---|---|
| International Prostate Symptom with quality of life score (IPSS-QoL) at 3 months after surgery | The severity of lower urinary tract symptoms and their impact on quality of life should be assessed using a validated questionnaire.
| At 3 months after HoLEP |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Male patients undergoing HoLEP for BPO.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Murat Gulsen, Assistant Professor | Contact | +905062357421 | mglotr@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Murat Gulsen | Ondokuz Mayıs University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ondokuz Mayis University, Faculty of Medicine, Department of Urology | Samsun | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39622439 | Background | Haehn DA, Chadha RM, Porter SB, Pathak RA, Lyon TD, Hochwald AP, Dora CD. Same-day Discharge Following Holmium Laser Enucleation of the Prostate Under Spinal Anesthesia: A Propensity Score Matched Comparison With General Anesthesia. Urology. 2025 Feb;196:260-264. doi: 10.1016/j.urology.2024.11.058. Epub 2024 Nov 30. | |
| 39382595 |
Not provided
Not provided
Individual participant data (IPD) will not be shared due to privacy concerns and data protection regulations, including the Turkish Personal Data Protection Law (KVKK).
Only aggregated, de-identified results will be reported in publications and presentations.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Duration of hospitalization |
Day(s) passed until discharge after HoLEP. |
| Postoperative second to seventh days after HoLEP. |
| Duration of catheterization | Day(s) passed until the removal of the bladder drainage catheter after HoLEP. | From the time of HoLEP until the removal of the catheter. |
| Ratio of high grade complications | Complications will be classified according to the Clavien-Dindo classification. Clavien-Dindo Grade III or higher is considered a high-grade complication. | From the time of HoLEP to 30 days after HoLEP. |
| Peak Urinary Flow (Qmax) | Peak urinary flow (mL/sec), at 3 months after HoLEP. | At 3 months after HoLEP. |
| Post-void residual (PVR) | Post-void residual (PVR) volume (mL) measurement at 3 months after HoLEP | At 3 months after HoLEP |
| Enucleation Efficiency | Weight of the enucleated adenoma per operative minute (grams/min). | From the start of HoLEP to the end of HoLEP (Operative time). |
| Ratio of intraoperative vasoactive medication requirement | 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. | During the anesthesia for HoLEP |
| Silvani C, Lucignani G, Bebi C, Turetti M, Ripa F, Zanetti SP, De Lorenzis E, Albo G, Longo F, Gadda F, Montanari E, Boeri L. General anesthesia is associated with lower perioperative bleeding and better functional outcomes than spinal anesthesia for endoscopic enucleation of the prostate: a single-center experience. World J Urol. 2024 Oct 9;42(1):569. doi: 10.1007/s00345-024-05271-z. |
| 34339752 | Background | Westhofen T, Schott M, Keller P, Tamalunas A, Atzler M, Ebner B, Schultheiss M, Damm A, Kowalski C, Stief CG, Magistro G. Spinal Versus General Anesthesia for Holmium Laser Enucleation of the Prostate of High-risk Patients - A Propensity-score-matched-analysis. Urology. 2022 Jan;159:182-190. doi: 10.1016/j.urology.2021.04.078. Epub 2021 Jul 31. |