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临床试验/NCT05330156
NCT05330156Unknown不适用

Transurethral Resection Versus Transurethral Enucleation of the Prostate: Prospective Randomized Study

Assiut University2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2022年4月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
58
试验地点
2
主要终点
Time of operation

研究概览

简要总结

TUERP technique could be used in prostates of all sizes with the same safety and efficacy "size independent procedure" . TUERP could be performed using the bipolar system only ,with or without the use of morcellator.

详细描述

Transurethral resection of the prostate (TURP) was first done in the 1920s. Since then, TURP has been considered as the gold standard treatment for BPH . However, its relatively high complication rate and postoperative recurrence necessitates further modification in the surgery technique .The resected adenomas have been reported to recur in up to 15% of cases that need a repeat surgical intervention, even by experienced surgeons in high-volume centers .

Before the era of TURP, simple open prostatectomy was the mainstay of surgical therapy. However, open simple prostatectomy has high risk of considerable intraoperative bleeding requiring transfusion. The lower abdominal incision done in open prostatectomy may result in significant postoperative pain, an extended recovery period and longer hospital stay, with greater morbidity and a perioperative mortality rate of 0.2%. In addition, TURP for large prostatic adenomas causes significantly much more bleeding with clot retention as compared to simple open prostatectomy, it also need a longer operative time, which leads to increased risk of TUR syndrome with subsequent morbidity . A new technique in which transurethral enucleation and resection of the prostate (TUERP) was developed and adopted to replicate the open enucleation of prostatic adenomas in an endoscopic way. This will combine the benefits of complete prostate enucleation in a minimally invasive technique . prostate enucleation by laser currently used as minimally invasive and save alternative to TURP, but still has not been widely accepted for some reasons, including high cost and prolonged learning curve.

TUERP technique could be used in prostates of all sizes with the same safety and efficacy "size independent procedure" . TUERP could be performed using the bipolar system only ,with or without the use of morcellator

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
None

入排标准

性别
Male
接受健康志愿者

入选标准

  • -Patients aging from 50 to 80 years old who are diagnosed with clinical symptomatic BPH.
  • The patients have clear indi¬cation 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 Poor general condition of the patient

结局指标

主要结局

Time of operation

时间窗: intraoperative (from the start of resection or enucleation till the fixation of urethral catheter)

time used for resection or enucleation and resection of the prostate

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 FARAHAT HASSAN

principal investigator

Assiut University

研究点 (2)

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