跳至主要内容
临床试验/NCT06038890
NCT06038890招募中不适用

The Learning Curve of Transurethral Holmium Laser Enucleation of the Prostate, Multicenter Prospective Assessment Through a Novel Technique

Mansoura University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年8月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Elshal

Professor of Urology

Mansoura University

研究点 (2)

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