Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Comparison of the Learning Curves of Tri-lobar Versus En-bloc Holmium Laser Enucleation of the Prostate: A Prospective Randomized Clinical Trial
Several HoLEP techniques have been developed, with the conventional tri-lobar and the en-bloc approaches being the most commonly practiced. Although both techniques achieve comparable functional outcomes and safety profiles, they differ in surgical dissection strategy and anatomical orientation. Some authors suggest that the en-bloc technique may facilitate maintenance of the correct surgical plane, whereas others consider the tri-lobar approach easier for surgeons familiar with transurethral resection of the prostate (TURP). However, evidence comparing their learning characteristics remains limited.
Most published studies evaluating the HoLEP learning curve have investigated a single surgical technique or assessed a second technique after surgeons had already gained substantial HoLEP experience. Such study designs introduce significant bias because increasing surgical experience inevitably influences subsequent performance.
A prospective alternating design, in which a HoLEP-naïve surgeon performs consecutive tri-lobar and en-bloc procedures, may provide a more balanced comparison by exposing both techniques to similar levels of cumulative surgical experience while minimizing temporal bias.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Tanta、埃及
- 招聘中
- Faculty of Medicine, Tanta University
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接触:
- Mahmoud Mohamed Elrefaey, Lecturer of Urology
- 电话号码:+201283625007
- 邮箱:mahmoud.elrefaey@med.tanta.edu.eg
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- BPH requiring HoLEP
- Prostate 80-150 cc
- Performed by surgeons with no previous independent experience in the evaluated techniques
Exclusion Criteria:
- Previous prostate surgery
- Neurogenic bladder
- Prostate cancer
- Simultaneous bladder surgery
- Extremely large prostates (>150 cc)
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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其他:Tri-lobar HoLEP
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endoscopic, retro-grade dissection and liberation of the entire transition zone of the prostate (the hyperplastic adenoma) from the surrounding surgical capsule as 3 specimens (median lobe and 2 lateral lobes) using a holmium:yttrium-aluminum-garnet (Ho:YAG) laser |
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实验性的:En-bloc HoLEP
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endoscopic, retro-grade dissection and liberation of the entire transition zone of the prostate (the hyperplastic adenoma) from the surrounding surgical capsule as a single, intact specimen using a holmium:yttrium-aluminum-garnet (Ho:YAG) laser |
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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Number of cases required to achieve procedural proficiency
大体时间:1 year
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Number of cases required to achieve procedural proficiency, defined by a sustained plateau in enucleation efficiency (enucleated weight in gm/operative time in min) determined using RA-CUSUM. Risk-adjusted CUSUM adjusts for:
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1 year
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Enucleation time
大体时间:1 year
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1 year
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Morcellation time
大体时间:1 year
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1 year
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Enucleated weight
大体时间:1 year
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1 year
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
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
其他研究编号
- 36265PR227/9/26
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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