An interventional study of Spinal anesthesia and General anesthesia in Urologic Neoplasms, Benign Prostatic Hyperplasia and Anesthesia, sponsored by Hitit University. Recruiting at 2 sites in Turkey (Türkiye). Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Hitit University · Not applicable, Interventional, and Treatment
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.
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.
155 studies on the registry are indexed under Urologic Neoplasms; 40 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 109 interventional studies indexed under Urologic Neoplasms.
Browse Urologic Neoplasms studies →Hitit University is the lead sponsor of 87 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants allocated to this arm will receive spinal anesthesia for open simple prostatectomy according to the institutional standard anesthesia protocol.
Procedure: Spinal anesthesia
Participants allocated to this arm will receive general anesthesia for open simple prostatectomy according to the institutional standard anesthesia protocol.
Procedure: General anesthesia
Spinal anesthesia will be performed at the L3-4 or L4-5 interspace under aseptic conditions using hyperbaric bupivacaine. Light sedation may be administered when clinically required.
General anesthesia will be induced and maintained according to the institutional standard protocol. Airway management, mechanical ventilation, anesthetic maintenance, antiemetic prophylaxis, and multimodal analgesia will be applied according to routine clinical practice.
Clinically Significant Postoperative Bleeding
Clinically significant postoperative bleeding is defined as the occurrence of at least one of the following events: Requirement for red blood cell transfusion; Hemoglobin decrease ≥2 g/dL accompanied by persistent gross hematuria and/or ongoing bladder irrigation; Clot retention requiring intensified bladder irrigation or endoscopic clot evacuation; Bleeding-related reintervention.
Time frame: Within 72 hours after surgery
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Aug 2026, 3 months after the start.
Of 23 interventional studies with no phase under Urologic Neoplasms, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 64. This study's planned 3 months is below that.
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