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临床试验/NCT06922968
NCT06922968尚未招募不适用

Standard Versus Transrectal Ultrasound (TRUS)-Guided Endoscopic Treatment of Benign Prostatic Hyperplasia: A Prospective Randomized Controlled Trial

Assiut University1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
114
试验地点
1
主要终点
efficacy of endoscopic treatment of BPH

研究概览

简要总结

The study aims to evaluate the role of TRUS in improving the efficacy and safety of endoscopic enucleation of prostate and TURP.

详细描述

Standard TURP is an established procedure for managing BPH but has limitations, including the risk of incomplete adenoma removal and complications such as bleeding. Research on transurethral enucleation techniques has demonstrated potential for improved outcomes, especially in larger prostates. However, challenges persist in achieving precise resection boundaries and minimizing intraoperative risks.

TRUS, widely utilized for prostate biopsy and volume assessment, has recently gained attention for its intraoperative applications. Studies show that real-time TRUS provides accurate imaging of prostate anatomy and resection planes, helping surgeons better differentiate adenomatous tissue from surrounding structures. This enhances surgical precision, reduces intraoperative bleeding, and minimizes residual tissue, leading to better outcomes in procedures like TURP and enucleation.

Current TURP and enucleation approaches depend heavily on endoscopic visual guidance, which, despite significant advancements, can lead to residual tissue, excessive bleeding, and prolonged recovery. While enucleation techniques have addressed some of these challenges, they remain less accessible due to high costs and steep learning curves, making them unsuitable for all healthcare settings.

Integrating TRUS into TURP or enucleation offers the potential to address these limitations by enhancing tissue differentiation and guiding precise resection. This study aims to evaluate the efficacy of TRUS in reducing complications, achieving complete tissue removal, and improving patient recovery outcomes, potentially paving the way for its routine adoption in BPH surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Male patients aged 50-80 years
  • •Diagnosed with benign prostatic hyperplasia (BPH) and scheduled for TURP or prostatic adenoma enucleation.
  • •The patients have clear indication for endoscopic surgery (according to the guidelines).
  • •Clinically fit patients for surgery.
  • •Signed an informed consent.

排除标准

  • •• Prostate cancer
  • •Previous urethral or prostate surgery
  • •Neurogenic bladder
  • •Urethral stricture

研究组 & 干预措施

Control group

Experimental

Control cases under went TURP and enucleation

干预措施: Standard TURP and enucleation (Procedure)

TRUS Guided group

Experimental

TRUS guided group during TURP and enucleation

干预措施: TRUS-Guided TURP and enucleation (Procedure)

结局指标

主要结局

efficacy of endoscopic treatment of BPH

时间窗: At 12 weeks after the procedure

Intervention efficacy will be evaluated by comparing the Peak flow rate in ml/second.(measured by uroflowmetry) between the two groups

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

Mohamed ElSharkawy

Principal Investigator

Assiut University

研究点 (1)

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