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Anesthesia Type and HoLEP Outcomes: A Multi-Center Study

9 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

320

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Murat Gulsen, Assistant Professor
  • Telefoonnummer: +905062357421
  • E-mail: mglotr@gmail.com

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

Male patients undergoing HoLEP for BPO.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hemoglobin change
Tijdsspanne: First day after HoLEP is performed.
Difference between preoperative and postoperative hemoglobin levels (g/dL)
First day after HoLEP is performed.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
International Prostate Symptom with quality of life score (IPSS-QoL) at 3 months after surgery
Tijdsspanne: 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
Tijdsspanne: Postoperative second to seventh days after HoLEP.
Day(s) passed until discharge after HoLEP.
Postoperative second to seventh days after HoLEP.
Duration of catheterization
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: At 3 months after HoLEP.
Peak urinary flow (mL/sec), at 3 months after HoLEP.
At 3 months after HoLEP.
Post-void residual (PVR)
Tijdsspanne: At 3 months after HoLEP
Post-void residual (PVR) volume (mL) measurement at 3 months after HoLEP
At 3 months after HoLEP
Enucleation Efficiency
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ondokuz Mayıs University

Onderzoekers

  • Hoofdonderzoeker: Murat Gulsen, Ondokuz Mayıs University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

23 april 2026

Primaire voltooiing (Geschat)

1 augustus 2027

Studie voltooiing (Geschat)

1 september 2027

Studieregistratiedata

Eerst ingediend

5 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

9 mei 2026

Eerst geplaatst (Werkelijk)

13 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

9 mei 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • MIUS.2026.002

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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