The Learning Curve of Transurethral Holmium Laser Enucleation of the Prostate, Multicenter Prospective Assessment Through a Novel Technique
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- time to plateau in enucleation effeminacy
研究概览
简要总结
Despite the high-quality evidence supporting the safety and efficacy of Holmium laser enucleation of the prostate (HOLEP), wide adoption of the procedure is hindered by learning difficulties. Veil-sparing HOLEP was popularized with a standardized approach to learning.
Prospective multicenter assessment of the learning curve of HoLEP through a novel technique with structured learning protocol.
Learning outcome measures will be assessed against time and number of performed cases of new learners in a multicenter study.
详细描述
INTRODUCTION Holmium laser enucleation of the prostate (HoLEP) was described in 1998 1 and since then, it has the highest level of evidence supporting its safety, efficacy and durability in treating benign prostate hyperplasia (BPH) 2.
Furthermore, it is a cost-effective alternative both in developing3 and developed4 countries. Nevertheless, learning difficulties hinder wide adoption of this technique among urologists and even more some centers discontinue doing this technique due complications encountered early in the learning curve5.
Performance of a task repetitively changes with experience over time. Plotting performance (outcome measures) against experience (number of performed tasks) produces a learning curve.
Improvement tends to be rapid at first and then tails off over time until a steady state is reached (Plateau) 6. Time-To-Plateau (TTP); number of HoLEP tasks is variably reported; 20-307-9, 5010 or even more procedures were reported as time needed to reach steady state (plateauing).
Elshal et al in 2023 compared this novel veil sparing approach in a comparitve study with the standard HOLEP approach and concluded that the veil sparing approach was associated with better short term urine continence.11 In this work we aim at assessment of the learning curve using this novel technique (Veil sparing HOLEP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with prostate volume (≥40 cc) who are indicated for transurethral surgery for the BPO.
排除标准
- •Patients with IPSS <
- •Patients with Qmax >15 mL/s.
- •Presence of urethral stricture.
- •Patients with neurogenic bladder.
- •Patients with prostate cancer.
- •Patients with previous prostate surgery.
结局指标
主要结局
time to plateau in enucleation effeminacy
时间窗: one year
time needed to reach a fixed rate of grams of prostate tissue removed per unit time (minute)
次要结局
未报告次要终点
研究者
Ahmed Elshal
Professor of Urology
Mansoura University
