Anesthesia Type and HoLEP Outcomes: A Multi-Center Study

Официальное название

Does Anesthesia Type Affect HoLEP Outcomes? A Multi-Center, Real-World Comparative Study

Обзор

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.

Подробное описание

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:

* Bothersome LUTS resistant to medical treatment. * Acute kidney injury, bladder stone(s), resistant hematuria and urinary retention. * Preference of the patient.

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:

* Amount of hemoglobin and hematocrit decreased, measured by laboratory examinations, preoperatively, during, and on the day after the surgery. * Vital changes such as hypotension, tachycardia, that require blood transfusion due to "more" bleeding during either the surgery or hospital stay after surgery. * Usually, a shorter duration of bladder irrigation to clean blood in the urine during hospital stay after the surgery is required for "less" bleeding.

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.

Первичные конечные точки

• Hemoglobin change [Срок оценки: First day after HoLEP is performed.]

Вторичные конечные точки (8)

• International Prostate Symptom with quality of life score (IPSS-QoL) at 3 months after surgery [Срок оценки: At 3 months after HoLEP]
• Duration of hospitalization [Срок оценки: Postoperative second to seventh days after HoLEP.]
• Duration of catheterization [Срок оценки: From the time of HoLEP until the removal of the catheter.]
• Ratio of high grade complications [Срок оценки: From the time of HoLEP to 30 days after HoLEP.]
• Peak Urinary Flow (Qmax) [Срок оценки: At 3 months after HoLEP.]
• Post-void residual (PVR) [Срок оценки: At 3 months after HoLEP]
• Enucleation Efficiency [Срок оценки: From the start of HoLEP to the end of HoLEP (Operative time).]
• Ratio of intraoperative vasoactive medication requirement [Срок оценки: During the anesthesia for HoLEP]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.
• Participants who have a proven urinary tract infection at the time of the surgery.
• Participants who are not able to be contacted for regular follow-ups.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Ondokuz Mayis University, Faculty of Medicine, Department of Urology — Samsun

Публикации

• 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. PMID 39622439
• 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. PMID 39382595
• 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. PMID 34339752

Идентификаторы

NCT: NCT07585552 · MIUS.2026.002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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