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Spinal Versus General Anesthesia in Open Simple Prostatectomy

RecruitingNAAges 18 Years - anyMaleHitit University
NCT07643415 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Open simple prostatectomy is still performed for selected patients with benign prostatic hyperplasia, particularly in cases with large prostate volume. Postoperative bleeding, hematuria, clot retention, and transfusion requirement are clinically important complications after this procedure. This prospective randomized controlled trial will compare the effects of spinal anesthesia and general anesthesia on postoperative bleeding in patients undergoing open simple prostatectomy. Participants will be randomized into two groups: spinal anesthesia or general anesthesia. Tranexamic acid or any additional hemostatic agent will not be used. Postoperative bleeding will be assessed using hemoglobin and hematocrit changes, transfusion requirement, hematuria, clot retention, need for bladder irrigation, and bleeding-related reintervention. The study aims to determine whether spinal anesthesia is a

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male patients aged 18 years or older. * Diagnosis of benign prostatic hyperplasia (BPH). * Scheduled to undergo open simple prostatectomy. * American Society of Anesthesiologists (ASA) physical status I-III. * Ability to provide written informed consent. Exclusion Criteria: * Refusal or inability to provide informed consent. * Patients scheduled for radical prostatectomy due to prostate cancer. * Emergency surgery. * Known coagulation disorders or clinically significant thrombocytopenia. * Ongoing anticoagulant or antiplatelet therapy that cannot be discontinued according to institutional protocols. * Contraindication to spinal anesthesia. * Participation in another interventional clinical trial that may affect study outcomes. * Administration of tranexamic acid or any additional hemostatic agent during the perioperative period.
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What it tests

  • Spinal anesthesia
  • General anesthesia
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Where

2 sites
Hitit university
Çorum, Turkey (Türkiye)
hitit Üniversity
Çorum, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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