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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Anesthesia | Active Comparator | Participants allocated to this arm will receive spinal anesthesia for open simple prostatectomy according to the institutional standard anesthesia protocol. |
|
| General Anesthesia | Active Comparator | Participants allocated to this arm will receive general anesthesia for open simple prostatectomy according to the institutional standard anesthesia protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal anesthesia | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 72 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
The study includes only male participants because benign prostatic hyperplasia and open simple prostatectomy are conditions and procedures specific to individuals with a prostate gland.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mustafa Serdar Çağlayan | Contact | +905074311951 | serdar.09.09@hotmail.com | |
| Sibel Onen Ozdemir | Contact | +905442892194 | sibelonen89@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ozgur Yağan, Professor | Hitit University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hitit university | Recruiting | Çorum | 19030 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D011470 | Prostatic Hyperplasia |
| D019106 | Postoperative Hemorrhage |
| ID | Term |
|---|---|
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| General anesthesia | Procedure | 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. |
|
| hitit Üniversity | Recruiting | Çorum | 19030 | Turkey (Türkiye) |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014570 | Urologic Diseases |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |