Spinal Versus General Anesthesia in Open Simple Prostatectomy
Effect of Spinal Versus General Anesthesia on Postoperative Bleeding in Patients Undergoing Open Simple Prostatectomy: A Prospective Randomized Controlled Trial
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:MUSTAFA SERDAR ÇAĞLAYAN
- 电话号码:+905074311951
- 邮箱:serdar.09.09@hotmail.com
研究联系人备份
- 姓名:Sibel Onen Ozdemir
- 电话号码:+905442892194
- 邮箱:sibelonen89@gmail.com
学习地点
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Çorum、土耳其(türkiye)、19030
- 招聘中
- Hitit University
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接触:
- Mustafa Serdar Caglayan
- 电话号码:05074311951
- 邮箱:serdar.09.09@hotmail.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Spinal Anesthesia
Participants allocated to this arm will receive spinal anesthesia for open simple prostatectomy according to the institutional standard anesthesia protocol.
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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.
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有源比较器:General Anesthesia
Participants allocated to this arm will receive general anesthesia for open simple prostatectomy according to the institutional standard anesthesia protocol.
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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.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Clinically Significant Postoperative Bleeding
大体时间:Within 72 hours after surgery
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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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合作者和调查者
调查人员
- 学习椅:Ozgur Yagan, Professor、Hitit University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2026-18
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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