Transurethral Plasmakinetic Enucleation of Prostate Versus Transurethral Resection of Prostate: A Multi-center Randomized Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- Qmax(Maximum urinary flow rate)
研究概览
简要总结
The study is a multicentric randomized control trial with 4-year follow-up comparing perioperative and postoperative outcomes for transurethral plasmakinetic enucleation of prostate(TUKEP) and transurethral resection of prostate(TURP). The investigators recruit patient with benign prostatic hyperplasia(BPH) as the object of study. TURP is set as control group . Meanwhile TUKEP is set as test group. Six affiliated hospitals will participate in this study. Through analyzing the perioperative and postoperative data between TUKEP group and TURP group, The investigators purpose demonstrating superiority of safety, efficacy and economic benefit in TUKEP group.
详细描述
Benign prostatic hyperplasia (BPH) is the most common disease of middle aged and elderly people which cause urinary tract symptoms (LUTS). transurethral resection of prostate(TURP) , began to replace the traditional open surgery in 1930s, still is as the "gold standard" operation for surgical treatment of BPH. However, compared with the traditional open operation, TURP has the following flaws:(1), due to the incomplete resection , maximum flow rate(Qmax) after TURP is lower than Qmax after open surgery. (2), there are serious complications, such as water intoxication and hemorrhage. (3) TURP has limitation to large prostate.
Transurethral plasmakinetic enucleation of prostate(TUKEP), an operation mode devised by Liu Chunxiao Team in southern medical university urology department, have offset the advantage of TURP. The theory of the operation is using transurethral resectoscope instead of the finger in the open operation, to find the surgical capsule of prostate and to peel the hyperplastic prostate gland visually in a antidromic way. One the one hand, TUKEP effectively solve the situation that It should repeatedly cut and stop bleeding and difficultly find the surgical capsule in TURP, which obviously reduce the rate of bleeding, prostatic capsula perforation, transurethral resection syndrome(TURS) and External sphincter injury. On the other hand, TUKEP is the minimally invasive surgery. It also achieves the effect of open surgery resolving the residual gland and reoperation post TURP.
The investigators plan to setup a a multicentric randomized control trial with 4-year follow-up comparing perioperative and postoperative outcomes for TUKEP and TURP. Through analyzing the perioperative and postoperative data between TUKEP group and TURP group, The purpose demonstrating superiority of safety, efficacy and economic benefit in TUKEP group.
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 (Care Provider, 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
- 否
入选标准
- •Diagnose as BPH
- •Between 50 and 80 year-old
- •Prostate volume less than 120g
- •Meet any conditions (1). International Prostate Symptom Score (IPSS),≥12 quality of life score (QOL) ≥4 分 (2).Maximum urinary flow rate (Qmax) 15 ml/s or less (urine flow more than 150 ml) (3).Medication is not efficient (4).Repeated urinary retention (extubation failure more than one) (5).Schafer≥grade 2
- •The American association of anesthesia score (ASA) class 1 to 3
- •Sign the informed consent voluntarily and will be willing to follow-up
排除标准
- •Combined with central nervous system lesions (such as cerebrovascular accident, Parkinson, multiple sclerosis, cauda equina injury, spinal cord lesions, etc.) and neurogenic bladder;
- •The combination of advanced malignant tumor or chronic wasting disease;
- •Patients with severe cardiopulmonary disease or severe mental disorders;
- •Acute urinary tract infection, urethral stricture;
- •There is a history of prostate and bladder surgery;
- •Combined with severe coagulopathy;
- •Postoperative pathology confirmed prostate cancer;
- •Poor compliance, and can not be followed up.
结局指标
主要结局
Qmax(Maximum urinary flow rate)
时间窗: 4 years
Maximum urinary flow rate was measured at 1, 3, 6, 12, 24, 36 and 48-month postoperatively
IPSS (International Prostate Symptom Score )
时间窗: 4 years
International Prostate Symptom Score was measured at 1, 3, 6, 12, 24, 36 and 48-month postoperatively
次要结局
- International Index Of Erectile Function (IIEF-5)(4 years)
- Postoperative hospital stay(1 month)
- QOL(Quality of Life)(4 years)
- Indwelling catheter time(1 month)
- Hospitalization expenses(1 month)
- Residual urine volume(4 years)
- Claviendindo classification(4 years)
- Postoperative irrigation(1 month)
- Retreatment rate(4 years)
- Prostate volume(4 years)
- Operation time(up to 24 hours)
- Prostate-specific antigen(PSA)(4 years)
- Decrease in Haemoglobin in 24 hours post-operation(1 month)