Suprapubic Cystostomy as an Adjunct to Monopolar Transurethral Enucleation of the Prostate for Large Benign Prostatic Hyperplasia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Operative time
研究概览
简要总结
SPC use has previously been evaluated in monopolar transurethral enucleation and resection of the prostate (M-TUERP) compared with bipolar TURP [10]. However, to our knowledge, this is the first randomized controlled trial to compare outcomes of M-TUEP performed with versus without SPC in balanced patient groups. This study evaluates the safety and efficacy of M-TUEP with and without SPC in 160 patients with large prostatic adenomas.
To evaluate whether suprapubic cystostomy (SPC) improves the safety and operative efficiency of monopolar transurethral enucleation of the prostate (M-TUEP) in patients with large benign prostatic hyperplasia (BPH).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age ≥50 years
- •prostate volume ≥80 cc assessed by transrectal ultrasonography
- •moderate-to-severe lower urinary tract symptoms (International Prostate Symptom Score; IPSS ≥8)
- •failure or intolerance of medical therapy.
排除标准
- •suspected or confirmed prostate cancer
- •prior prostate surgery
- •neurogenic bladder dysfunction
- •urethral stricture disease
- •active urinary tract infection
- •bladder stones requiring open surgery
- •uncorrected coagulopathy.
研究组 & 干预措施
Group A: Monopolar transurethral enucleation of the prostate (M-TUEP) without suprapubic cystostom
干预措施: Monopolar transurethral enucleation of the prostate without suprapubic cystostomy (Procedure)
Group B: M-TUEP with concomitant SPC
干预措施: Monopolar transurethral enucleation of the prostate with suprapubic cystostomy (Procedure)
结局指标
主要结局
Operative time
时间窗: Intraoperative
Operative time will be assessed as the total duration of the surgical procedure, measured in minutes from the start of resection to completion of surgery. Shorter operative times indicate greater procedural efficiency.
Resection Efficiency Calculated From Resected Tissue Weight and Operative Time
时间窗: Intraoperative
Resection efficiency will be assessed by dividing the weight of resected prostatic tissue (grams) by operative time (minutes), expressed as grams per minute (g/min). Higher values indicate greater surgical resection efficiency.
次要结局
- International Prostate Symptom Score (IPSS)(1, 6, and 12 months)
- Maximum Urinary Flow Rate Assessed by Uroflowmetry (Qmax)(1, 6, and 12 months)
- Hemoglobin Level Assessed by Laboratory Blood Analysis(Baseline and immediately after the intervention)
- Serum Sodium Level Assessed by Laboratory Blood Analysis(Baseline and immediately after the intervention)
- Catheterization Time Following Surgery(immediately after the intervention)
- Length of Hospital Stay Following Surgery(immediately after the intervention)
- Perioperative Complications Assessed During the Perioperative Period(perioperatively)
研究者
Ahmed Gamal
Associate professor
Beni-Suef University