NCT07643415 Spinal Versus General Anesthesia in Open Simple Prostatectomy
| NCT ID | NCT07643415 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hitit University |
| Condition | Urologic Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-04-29 |
| Primary Completion | 2026-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-04-29 with a primary completion date of 2026-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 associated with reduced postoperative bleeding compared with general anesthesia in open simple prostatectomy.
Eligibility 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.
Contact & Investigator
Ozgur Yağan, Professor
STUDY CHAIR
Hitit University
Frequently Asked Questions
Who can join the NCT07643415 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Urologic Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07643415 currently recruiting?
Yes, NCT07643415 is actively recruiting participants. Contact the research team at serdar.09.09@hotmail.com for enrollment information.
Where is the NCT07643415 trial being conducted?
This trial is being conducted at Çorum, Turkey (Türkiye), Çorum, Turkey (Türkiye).
Who is sponsoring the NCT07643415 clinical trial?
NCT07643415 is sponsored by Hitit University. The principal investigator is Ozgur Yağan, Professor at Hitit University. The trial plans to enroll 80 participants.