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Anesthesia Type and HoLEP Outcomes: A Multi-Center Study

9. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Antatt)

320

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Murat Gulsen, Assistant Professor
  • Telefonnummer: +905062357421
  • E-post: mglotr@gmail.com

Studiesteder

  • Tyrkia (Türkiye)
      • Samsun, Tyrkia (Türkiye)
        • Ondokuz Mayis University, Faculty of Medicine, Department of Urology
        • Ta kontakt med:
          • Murat Gulsen, Assistant Professor
          • Telefonnummer: +905062357421
          • E-post: mglotr@gmail.com

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Male patients undergoing HoLEP for BPO.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Hemoglobin change
Tidsramme: First day after HoLEP is performed.
Difference between preoperative and postoperative hemoglobin levels (g/dL)
First day after HoLEP is performed.

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ondokuz Mayıs University

Etterforskere

  • Hovedetterforsker: Murat Gulsen, Ondokuz Mayıs University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

23. april 2026

Primær fullføring (Antatt)

1. august 2027

Studiet fullført (Antatt)

1. september 2027

Datoer for studieregistrering

Først innsendt

5. mai 2026

Først innsendt som oppfylte QC-kriteriene

9. mai 2026

Først lagt ut (Faktiske)

13. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • MIUS.2026.002

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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