Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate. A Prospective Randomized Multicentric Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 12
- 主要终点
- Postoperative hospital stay
研究概览
简要总结
Introduction: Multiple studies have demonstrated the superiority of HoLEP in aspects such as transfusión rates or postoperative stay. On the other hand, no differences have been observed in terms of functional outcomes between both techniques, and surgical times reported in different studies tend to be longer for HoLEP. These results likely contribute to TURP, especially with bipolar energy (Bi-TURP), continuing to be considered by many the gold standard for surgical treatment of BPH.
Sofware and hardware upgrades to the Lumenis Pulse 120H. system in 2017, delivered MOSES 2.0, a single-use laser fibre used to perform MOSES augmented HoLEP (MoLEP). MoLEP has shown to be superior in intraoperative outcomes when compared to traditional HoLEP. The availability of new morcellators might also decrease surgical time for HoLEP. This changing landscape for BPH endoscopic surgery deserves a re-evaluation of the differences between Bi-TURP and MoLEP.
Primary Objective: To compare the hospital stay of patients of patients undergoing MoLEP with those undergoing Bi-TURP.
Secondary objectives:
- To compare the surgical time of MoLEP with that of Bi-TURP.
- To compare the bladder catheterization time aCer MoLEP with that of Bi-TURP.
- To compare the postoperative complication rate patients undergoing MoLEP with those undergoing Bi-TURP.
- To compare functional results of patients undergoing MoLEP with those undergoing Bi-TURP.
This study is a prospective multicentric randomized and controlled trial. The study compares two types of BPH surgery without changing standard medical practice.
The study will include patients who are candidates according to standard medical practice for BPH surgery. Patients will be randomized to one of two groups of treatment.
- The MoLEP group will receive surgical treatment with MoLEP.
- The Bi-TURP group will receive surgical treatment with Bi-TURP. Surgical technique and postoperative care will follow standard clinical practice at each participating centre.
详细描述
Introduction: The evolution of surgery for benign prostatic hyperplasia (BPH) has come a long way since Freyer described his technique of open adenomectomy over 100 years ago. The advancement of instruments and surgical techniques has made surgery increasingly les invasive. Transurethral resection of the prostate (TURP) allowed endoscopic treatment of BPH and it is still regarded by many as the gold-standard for BPH surgical treatment. The application of Holmium laser for endoscopic enucleation of the prostate (HoLEP) in the last 20 years has allowed for the surgical treatment of BPH through an endoscopic approach, practically without limitations in prostate size.
Multiple studies have demonstrated the superiority of HoLEP in aspects such as transfusión rates or postoperative stay. On the other hand, no differences have been observed in terms of functional outcomes between both techniques, and surgical times reported in different studies tend to be longer for HoLEP. These results likely contribute to TURP, especially with bipolar energy (Bi-TURP) continuing to be considered by many the gold standard for surgical treatment of BPH.
However, the available studies often have short follow-up periods, most do not report on the surgeon's experience with HoLEP, and were based on early laser and morcellation technology. Sofware and hardware upgrades to the Lumenis Pulse 120H system in 2017, delivered MOSES 2.0, a single-use laser fibre used to perform MOSES augmented HoLEP (MoLEP). MoLEP has shown to be superior in intraoperative outcomes when compared to traditional HoLEP, resulting in shorter enucleation, haemostasis, and total surgical times for similar energy delivered. The availability of new morcellators might also decrease surgical time for HoLEP. This changing landscape for BPH endoscopic surgery deserves a re-evaluation of the differences between Bi-TURP and MoLEP.
Hypothesis: MoLEP surgery is superior to Bi-TURP in terms of postoperative stay, bladder catheter duration, blood loss and transfusion rate, without significant functional outcomes, and retreatment rate, with no significant differences in surgical time.
Objectives:
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
- 否
入选标准
- •Patients with maximum flow rate < 15 ml/sec before obstructive surgery or with maximum flow rate > 15 ml/sec and urodynamic study showing high-flow obstruction defined as bladder outlet obstruction index >
- •Patients with moderate to severe lower urinary tract symptoms (LUTS) according to the International Prostate Symptom Score (IPSS). Score between 8 and
- •Patients with a prostate volume between 40 and 80 cc, measured by urological ultrasound or MRI.
排除标准
- •History of prior prostatic obstructive or urethral surgery.
- •Diagnosis of prostate neoplasia.
- •Diagnosis of urothelial neoplasia.
- •Lack of flowmetry or IPSS data before surgery.
- •Diagnosis or suspicion of hypo/acontractile detrusor before prostatic obstructive surgery.
- •Diagnosis or suspicion of neurogenic bladder or neurological disease.
- •History of pelvic radiation therapy.
结局指标
主要结局
Postoperative hospital stay
时间窗: From date and time of end of surgery to date and time of hospital discharge assessed up to 1 month
Variation in length of hospital stay after each procedure. Difference in postoperative hospital stay time between MoLEP and BiTURP. Number of hours in the hospital after the procedure if finished, organized in the following categories: Outpatient procedure (less than 16 hours), 1 day of hospitalization (≤ 24 hours), 2 days of hospitalization (≤ 48 hours), 3 days of hospitalization (≤ 72 hours). Individual length of stay will be recorded).
次要结局
- Perioperative complications(From date of surgery to date of the end of follow-up 5 years)
- TREATMENT(From date of surgery to date of the end of follow-up 5 years)
- Urinary symptoms(From date of enrollment to date of the end of follow-up 5 years)
- SURGICAL TIME(Total time of Surgery procedure)
- The bladder catheterization time(Total time of bladder catheterization procedure)
研究者
Ivan Schwartzmann, MD
Principal Investigator
Fundacio Puigvert