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Anesthesia Type and HoLEP Outcomes: A Multi-Center Study

9 mai 2026 mis à jour par: Murat Gulsen, Ondokuz Mayıs University

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

  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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

320

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Murat Gulsen, Assistant Professor
  • Numéro de téléphone: +905062357421
  • E-mail: mglotr@gmail.com

Lieux d'étude

  • Turquie (Türkiye)
      • Samsun, Turquie (Türkiye)
        • Ondokuz Mayis University, Faculty of Medicine, Department of Urology
        • Contact:
          • Murat Gulsen, Assistant Professor
          • Numéro de téléphone: +905062357421
          • E-mail: mglotr@gmail.com

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

Male patients undergoing HoLEP for BPO.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
General Anesthesia
Participants undergoing HoLEP under general anesthesia (intubation or laryngeal mask airway)
Spinal Anesthesia
Participants undergoing HoLEP under spinal anesthesia

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Hemoglobin change
Délai: First day after HoLEP is performed.
Difference between preoperative and postoperative hemoglobin levels (g/dL)
First day after HoLEP is performed.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
International Prostate Symptom with quality of life score (IPSS-QoL) at 3 months after surgery
Délai: 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.

  • 0 to 35 points for IPSS
  • 0 to 6 points for QoL Scale variable.
At 3 months after HoLEP
Duration of hospitalization
Délai: Postoperative second to seventh days after HoLEP.
Day(s) passed until discharge after HoLEP.
Postoperative second to seventh days after HoLEP.
Duration of catheterization
Délai: From the time of HoLEP until the removal of the catheter.
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
Délai: 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.
From the time of HoLEP to 30 days after HoLEP.
Peak Urinary Flow (Qmax)
Délai: At 3 months after HoLEP.
Peak urinary flow (mL/sec), at 3 months after HoLEP.
At 3 months after HoLEP.
Post-void residual (PVR)
Délai: At 3 months after HoLEP
Post-void residual (PVR) volume (mL) measurement at 3 months after HoLEP
At 3 months after HoLEP
Enucleation Efficiency
Délai: From the start of HoLEP to the end of HoLEP (Operative time).
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
Délai: 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.
During the anesthesia for HoLEP

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ondokuz Mayıs University

Les enquêteurs

  • Chercheur principal: Murat Gulsen, Ondokuz Mayıs University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

23 avril 2026

Achèvement primaire (Estimé)

1 août 2027

Achèvement de l'étude (Estimé)

1 septembre 2027

Dates d'inscription aux études

Première soumission

5 mai 2026

Première soumission répondant aux critères de contrôle qualité

9 mai 2026

Première publication (Réel)

13 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 mai 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • MIUS.2026.002

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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