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临床试验/NCT07642063
NCT07642063Enrolling By Invitation不适用

Inverted-T Incision With Early Apical Release Technique vs. Three-Lobe Technique in Holmium Laser Enucleation of The Prostate: A Comparative Study

Benha University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2026年3月20日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
140
试验地点
1

研究概览

简要总结

Aim of the work is to compare the surgical efficacy and perioperative outcomes of the inverted-T incision with early apical release technique versus the standard three-lobe technique in patients undergoing Holmium Laser Enucleation of The prostate for Benign prostatic hyperplasia .

Primary outcome :

  • Technical operative time (started from the activation of the holmium laser for enucleation of the prostate lobes and ending after completion of morcellation )

Secondary outcome:

  • Laser energy used.
  • Intraoperative blood loss (change in hemoglobin level).
  • Learning curve.

详细描述

Benign prostatic hyperplasia is a histologic diagnosis that refers to the proliferation of smooth muscle and epithelial cells within the prostatic transition zone.

Treatment options for Benign prostatic hyperplasia range from watchful waiting and lifestyle changes for mild cases to medications that relax smooth muscles of prostatic urethra (alpha-blockers) or decrease the prostate size (5-alpha reductase inhibitors) .

Minimally invasive procedures or surgery (e.g. transurethral resection or anatomical endoscopic enucleation) are the treatment of choice for cases that don't respond to medical treatment and for more severe and complicated symptoms . Tailoring the treatment depends on individual factors like symptom severity, prostate size, age, and tolerance to side effects .

Holmium Laser Enucleation of the Prostate has been established as a gold standard surgical treatment for Benign prostatic hyperplasia of all prostate sizes due to its efficacy, durability, and low complication rates . Holmium Laser Enucleation of the Prostate involves enucleation of the adenoma from the surgical capsule using a holmium laser, followed by morcellation of the enucleated tissue . The standard technique typically involves identifying and dissecting three lobes (median and lateral lobes) .

While effective, the standard three-lobe technique can be technically demanding, particularly in larger glands or those with complex anatomy. Also, it involves multiple incisions which are associated with increased risk of complications. This may lead to longer operating times, increased laser energy usage, and a steeper learning curve .

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
Double (Participant, Outcomes Assessor)

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

入选标准

  • Male patients aged 50-80 years.
  • Prostate size ≥ 80 mL.
  • Candidates for Holmium Laser Enucleation of the Prostate based on clinical and radiological evaluation

排除标准

  • Suspected or confirmed prostate cancer.
  • Previous prostate or urethral procedure (excluding prostate biopsy).
  • Urethral stricture.
  • Active urinary tract infection.
  • Urinary bladder mass, stone or diverticulum.
  • Severe coagulopathy or inability to discontinue anticoagulant/antiplatelet medications.
  • Unwillingness to comply with follow-up protocol

研究者

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

Abdelmonaem Mohamed Elhadey Mohamed

Urology Specialist, Ministry of Health

Benha University

研究点 (1)

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