Anesthesia Type and HoLEP Outcomes: A Multi-Center Study
Does Anesthesia Type Affect HoLEP Outcomes? A Multi-Center, Real-World Comparative Study
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:
- 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.
- 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.
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Murat Gulsen, Assistant Professor
- Número de telefone: +905062357421
- E-mail: mglotr@gmail.com
Locais de estudo
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Samsun, Turquia (Türkiye)
- Ondokuz Mayis University, Faculty of Medicine, Department of Urology
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Contato:
- Murat Gulsen, Assistant Professor
- Número de telefone: +905062357421
- E-mail: mglotr@gmail.com
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
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General Anesthesia
Participants undergoing HoLEP under general anesthesia (intubation or laryngeal mask airway)
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Spinal Anesthesia
Participants undergoing HoLEP under spinal anesthesia
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Hemoglobin change
Prazo: First day after HoLEP is performed.
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Difference between preoperative and postoperative hemoglobin levels (g/dL)
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First day after HoLEP is performed.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
International Prostate Symptom with quality of life score (IPSS-QoL) at 3 months after surgery
Prazo: At 3 months after HoLEP
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The severity of lower urinary tract symptoms and their impact on quality of life should be assessed using a validated questionnaire.
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At 3 months after HoLEP
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Duration of hospitalization
Prazo: Postoperative second to seventh days after HoLEP.
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Day(s) passed until discharge after HoLEP.
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Postoperative second to seventh days after HoLEP.
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Duration of catheterization
Prazo: From the time of HoLEP until the removal of the catheter.
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Day(s) passed until the removal of the bladder drainage catheter after HoLEP.
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From the time of HoLEP until the removal of the catheter.
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Ratio of high grade complications
Prazo: From the time of HoLEP to 30 days after HoLEP.
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Complications will be classified according to the Clavien-Dindo classification.
Clavien-Dindo Grade III or higher is considered a high-grade complication.
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From the time of HoLEP to 30 days after HoLEP.
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Peak Urinary Flow (Qmax)
Prazo: At 3 months after HoLEP.
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Peak urinary flow (mL/sec), at 3 months after HoLEP.
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At 3 months after HoLEP.
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Post-void residual (PVR)
Prazo: At 3 months after HoLEP
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Post-void residual (PVR) volume (mL) measurement at 3 months after HoLEP
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At 3 months after HoLEP
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Enucleation Efficiency
Prazo: From the start of HoLEP to the end of HoLEP (Operative time).
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Weight of the enucleated adenoma per operative minute (grams/min).
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From the start of HoLEP to the end of HoLEP (Operative time).
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Ratio of intraoperative vasoactive medication requirement
Prazo: During the anesthesia for HoLEP
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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.
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During the anesthesia for HoLEP
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Murat Gulsen, Ondokuz Mayıs University
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- MIUS.2026.002
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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.
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