Spinal vs. General Anesthesia for Open Simple Prostatectomy
Official title: Effect of Spinal Versus General Anesthesia on Postoperative Bleeding in Patients Undergoing Open Simple Prostatectomy: A Prospective Randomized Controlled Trial
Run by Hitit University · NCT07643415 · Data updated 2026-11-12
This trial tests whether spinal anesthesia reduces postoperative bleeding compared with general anesthesia in men undergoing open simple prostatectomy for BPH.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 80 (estimated) |
| Sponsor | Hitit University Academic / other |
| Locations | 2 sites (Çorum and 1 other locations) |
| Status | Recruiting |
| Started | April 29, 2026 |
| Main results expected | August 15, 2026 |
| Study ends | September 15, 2026 |
| Registry record updated | June 16, 2026 |
| Trial ID | NCT07643415 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Male patients aged 18 or older with BPH scheduled for open simple prostatectomy, ASA I–III, who can provide informed consent.
✕Probably not a fit
Patients with contraindications to spinal anesthesia, those on anticoagulation that cannot be safely paused, or those undergoing radical prostatectomy may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective randomized study compares two anesthesia approaches for open simple prostatectomy in men with BPH. Participants are randomized to receive either spinal or general anesthesia, with no tranexamic acid or additional hemostatic agents used perioperatively. Postoperative bleeding outcomes will be tracked through changes in hemoglobin and hematocrit, transfusion needs, presence of hematuria, clot retention, bladder irrigation requirements, and any bleeding-related reinterventions. The goal is to see if spinal anesthesia offers better bleeding control and recovery compared with general anesthesia. Safety and feasibility in an adult surgical population will also be observed.
Why it matters
Potential benefit: If spinal anesthesia reduces bleeding, patients may experience fewer transfusions and smoother recovery after open simple prostatectomy.
How similar studies have gone: Prior work has explored anesthesia effects on perioperative outcomes, but this specific comparison for open simple prostatectomy and bleeding outcomes is not well established, making this largely novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Hitit university
Çorum, Turkey (Türkiye) Recruiting -
hitit Üniversity
Çorum, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Mustafa Serdar Çağlayan
- Email: serdar.09.09@hotmail.com
- Phone: +905074311951
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.