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临床试验/NCT03305861
NCT03305861招募中不适用

GreenLight (532nm) LASER (XPS) Enucleation vs. Thulium LASER Enucleation of Prostate for Treatment of Benign Prostatic Hyperplasia

Mansoura University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2017年4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
110
试验地点
1
主要终点
voiding and storage symptoms improvement

研究概览

简要总结

In this study the investigators aim to test TGreenlight (532-nm) laser Photoselective Enucleation of the Prostate (Green LEP) using (XPS) 180W system ) vs Thulium Laser 200 W Enucleation of the Prostate (ThuLEP) in reduction of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) in a randomized controlled trial. Furthermore, all peri-operative parameters, urinary flow parameters, prostate size changes and complications associated with the procedures will be compared.

详细描述

Transurethral resection of the prostate (TURP) and open simple prostatectomy (SP) have been the historical reference-standard procedures for prostates < 80 g and ≥ 80 to 100 g, respectively, for years.

Evolution of LASER technology revived the concept of enucleation, so that the resectoscope can be used instead of the surgeon's index finger to separate the adenoma from the surgical capsule mimicking OP. There are several types of laser energy available for enucleation, but the commonest types are Holmium, Greenlight (532nm) and Thulim YAG LASERS.

Thulium: yttrium-aluminium-garnet laser Thulium LASER works at a wavelength between 1940 and 2013 nm in continuous wave mode so it offers advanced vaporization and hemostatic features. Different applications and techniques were developed ranging from vapoenucleation technique with in situ laser assisted resection, so-called Tangerine technique (Thulium Laser resection of the prostate Tangerine Technique "TmLRP-TT"), and enucleation (ThuVEP/ThuLEP are published.

Inspite of paucity of RCT comparing ThuLEP to other standard techniques in management of large prostate, long term outcomes of ThuLEP are so robust. Gross et al reported their 5 year follow up after ThuVEP in 500 patients with median prostate size of 50 grams. They demonstrated durable outcomes, with persistent reductions in I-PSS score (5 vs 21), QoL score (1 vs 4) and improvement in Q max (16.3 vs 6.9 ml/sec). Late complications included urethral stricture in 3.1%, BNC in 3.1% and recurrent adenoma in 0.6%.

Yang et al published their 5 year results of a RCT comparing ThuLEP vs TURis in 159 patients with median prostate size of 70 gm. No statistically significant difference between both groups in terms of IPSS, Qmax or post voiding residual. No patient in either group required retreatment.

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
40 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients' age ≥ 40 years
  • LUTS secondary to BOO due to BPH who failed medical treatment
  • International prostate symptom scores (IPSS) >15 and bother score (QOL) ≥ 3 (according to IPSS question 8)
  • Peak urinary flow rate (Qmax) <15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment.
  • ASA (American society of anaesthesiologists) score ≤
  • TRUS prostate size > /= 80 ml

排除标准

  • Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
  • Active urinary tract infection,
  • Presence of active bladder cancer (within the last 2 years)
  • Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.
  • Patient has a disorder of the coagulation cascade (e.g., liver cell failure) or disorders that affect platelet count or function (e.g., von Willebrand disease) that would put the subject at risk for intraoperative or postoperative bleeding.
  • Patient is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d) except for low-dose aspirin (e.g., 100 mg).
  • Patient has had an acute myocardial infarction or open-heart surgery <180 days prior to the date of informed consent.

结局指标

主要结局

voiding and storage symptoms improvement

时间窗: 6 months

International Prostate Symptom Score (I-PSS)

sexual function changes

时间窗: 6 months

International Index of Erectile Function Questionnaire (IIEF)

次要结局

  • Operative time(6 months)
  • Postoperative complication(12 months)

研究者

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

Mahmoud Laymon

MD

Mansoura University

研究点 (1)

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