Overview
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.
Description
Benign prostatic hyperplasia (BPH) is one of the most common urological conditions affecting aging men and may result in bladder outlet obstruction, lower urinary tract symptoms, recurrent urinary retention, urinary tract infections, bladder stones, hematuria, and renal dysfunction. Although minimally invasive surgical techniques have become increasingly popular, open simple prostatectomy remains an important treatment option for patients with very large prostate volumes and in centers where endoscopic enucleation techniques are not routinely available.
Bleeding remains one of the most clinically relevant complications following open simple prostatectomy. Postoperative hematuria, clot retention, prolonged bladder irrigation, blood transfusion, and bleeding-related reinterventions may increase morbidity, prolong hospitalization, and negatively affect postoperative recovery. Several surgical and perioperative strategies have been investigated to reduce perioperative bleeding; however, the influence of anesthesia technique on postoperative bleeding outcomes has not been adequately studied.
Spinal anesthesia may theoretically reduce perioperative bleeding through sympathetic blockade, decreased venous pressure, reduced pelvic venous congestion, and improved hemodynamic stability. In contrast, general anesthesia may be associated with greater hemodynamic fluctuations during induction, emergence, extubation, and positive-pressure ventilation, potentially affecting surgical bleeding. Despite these physiological considerations, evidence comparing spinal and general anesthesia with respect to postoperative bleeding after open simple prostatectomy remains limited.
The investigators observed in routine clinical practice that patients undergoing open simple prostatectomy under spinal anesthesia frequently appeared to experience a more stable perioperative course and less postoperative bleeding-related morbidity compared with patients receiving general anesthesia. This observation has not been prospectively evaluated in a randomized setting.
Therefore, this prospective randomized controlled trial aims to compare spinal anesthesia and general anesthesia in patients undergoing open simple prostatectomy. Participants will be randomized in a 1:1 ratio to receive either spinal anesthesia or general anesthesia. Tranexamic acid will not be administered in either group. Perioperative management, transfusion thresholds, and postoperative care protocols will be standardized.
The primary objective is to evaluate clinically significant postoperative bleeding within the first 72 hours after surgery. Secondary outcomes include perioperative hemoglobin and hematocrit changes, transfusion requirement, clot retention, duration of bladder irrigation, postoperative urinary functional outcomes, PSA changes, postoperative hospital stay, catheter duration, drain duration, renal function parameters, and perioperative complications classified according to the Clavien-Dindo system.
Eligibility
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.
