Holmium Laser Enucleation of the Prostate Versus Bipolar Transurethral Enucleation of the Prostate in Management of Benign Prostatic Hyperplasia A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- operative time
研究概览
简要总结
Benign prostatic hyperplasia (BPH) is one of the most common urinary disorders in elderly males. The symptoms of BPH include impaired physiological and functional well-being, which interferes with daily living.
At present, transurethral resection of the prostate (TURP) is the standard surgical treatment. However, the high rate of complications associated with TURP is a major drawback of this procedure.
Holmium laser enucleation of the prostate (HoLEP) was proven to be an effective surgical treatment for BPH with no prostate size limitation with adequate hemostasis, bipolar enucleation of the prostate (BPEP) has been introduced as an alternative energy source with a promising outcome with equal safety and efficacy
详细描述
Enlarged prostate represents the most common cause of lower urinary tract symptoms (LUTS) in elderly men including irritative, obstructive urinary symptoms or even urinary retention that significantly affects the quality life (QoL).
Transurethral resection of the prostate (TURP) represents the standard surgical technique for the management of benign prostatic hyperplasia (BPH) with a prostate size less than 80 ml. However, considerable morbidities are associated with larger sizes.
Endoscopic enucleation of the prostate (EEP) has been recognized as a treatment option for large prostatic adenomas, since first described by Hiraoka et.al, in 1986, it started to gain popularity despite the long learning curve. Many studies have evaluated its efficacy against the gold standard open prostatectomy in large prostate size more than 80ml and showed its safety and efficacy.
EEP represents an anatomical surgical technique resembling a surgeon's finger in open prostatectomy where any energy source that provides adequate haemostasis could be used. Many studies concluded that EEP relies on the surgeon's skills rather than the energy source itself. Holmium laser enucleation of the prostate (HoLEP) was first described by Gilling in 1998 and was proven to be effective with no prostate size limitation with adequate haemostasis, recently it has been approved as a standard treatment for large prostatic adenoma, bipolar enucleation of the prostate (BPEP) has been introduced as an alternative energy source with a promising outcome with equal safety and efficacy.
Few studies evaluated both techniques, one study was done by Shoma et al. showing no statistical difference regarding safety and efficacy between both techniques, another study conducted by Enikeev et al. reported earlier recovery and catheter removal with HoLEP compared to BPEP. However, cost-effectiveness was never been evaluated before between both techniques especially in developing countries.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
patients, data collector, and the statistician all were blinded to the type of intervention that was used in each group.
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men who are fit for surgery and need a surgical resection of the prostate larger than 80 ml including:
- •Bothersome LUTS with an IPSS score over 19
- •Refractory hematuria
- •Upper urinary tract affection
- •Recurrent UTI secondary to prostatic enlargement
- •Maximum uroflow rate (Qmax) below 10 ml/sec.
- •bladder diverticula
- •Urinary retention whether recurrent acute attacks with failure of medical treatment or chronic retention.
排除标准
- •Patients with:
- •Neurogenic bladder
- •Previous prostate or urethral surgery
- •Associated urethral stricture
- •Prostate cancer diagnosed by TRUS biopsy
- •Bladder stones,
结局指标
主要结局
operative time
时间窗: 50-120 minutes
form the beginning of endoscopic procedure till catheter insertion
次要结局
- resected volume(intra-operative finding)
- irrigation fluid(intra-operative finding)
- Cost analysis(1 year)
- Enucleation efficacy of BEEP(12 months)
- Enucleation efficacy of HoLEP(12 months)
- Mean energy in (HoLEP) in joules(intra-operative finding)
- catheter removal time(1-7 days)
- hemoglobin drop(intra-operative finding)
- conversion to other type of surgery(intra-operative finding)
- cost effectiveness(12 months)
- hospital stay(1-7 days)
- early post operative complication(1 month)
- Operative safety:(intra-operative finding)
- Postoperative efficacy:(12 months)
研究者
Ahmed Maher Gamil Ahmed Higazy
assistant lecturer of urology/ Specialist
Ain Shams University