To Compare the Effectiveness of the MOSES 2.0 Technology to the Non-MOSES Technology on the Success Rate of Holmium LASER Enucleation of the Prostate (HoLEP) Performed on an Outpatient Basis in the Context of Benign Prostatic Hypertrophy.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of hour's hospitalization
研究概览
简要总结
The aim of this study is to compare the success rate of outpatient surgery after holmium LASER enucleation of the prostate (HoLEP) for the treatment of BPH with and without the use of the MOSES 2.0 effect.
详细描述
HoLEP is in the process of becoming the new reference surgical treatment for BPH with the main advantages over monopolar transurethral resection (TURPm) and high approach adenomectomy (AVH): the significant reduction in morbidity perioperative period and therefore the reduction in the length of hospital stay. This reduction in length of stay has led to the development of outpatient care with encouraging results. The main cause of discharge failure on D0 is the persistence of postoperative hematuria requiring maintenance of bladder irrigation. MOSESTM 2.0 technology has the advantage of better hemostasis compared to the LASER LP100 currently used. The objective of this study is to evaluate the influence of MOSESTM 2.0 technology on the outpatient success rate in patients operated on for HoLEP for BPH.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject over 50 years old
- •BPH whose symptoms require surgical management
- •Preoperative prostate volume measured by ultrasound (suprapubic or transrectal) ≥ 40g
- •IPSS score > 15 and Quality of Life score ≥ 3
- •Maximum urinary output (Qmax) < 15 ml/sec
排除标准
- •Inability to read or write French
- •Patients with comorbidities contraindicating general anesthesia
- •Patients not eligible for outpatient care according to French recommendations (high risk of complications after general anesthesia, place of residence more than 150 km from an emergency department, alone at home the night following the intervention) .
- •History of BPH surgery
- •History of prostate cancer
- •Preoperative prostate volume measured by ultrasound (suprapubic or transrectal) < 40g
- •Existence or history of urethral stricture
- •Existence or suspicion of a "neurological" bladder
- •Positive preoperative cytobacteriological examination not treated appropriately
- •Adult patients subject to a legal protection measure or unable to express their consent
- •Patients deprived of liberty by a judicial or administrative decision or hospitalized without consent or admitted to a health or social establishment for purposes other than research
结局指标
主要结局
Number of hour's hospitalization
时间窗: baseline
Number of patient who discharge on D0 (same day of his surgery)
时间窗: baseline
次要结局
- Mean change in QoL before surgery and 3 months after surgery(3 months after surgery)
- Rate of enucleated prostate tissue By time treatment per patient(baseline)
- Mean evolution of Qmax and post-void residual (RPM) before the intervention and at 3 months post-operative(3 months after surgery)
- Intraoperative transfusion rate(baseline)
- Mean change in IPSS before surgery and 3 months after surgery(3 months after surgery)
- Readmission rate within 48 hours of discharge from hospital(baseline)
- Number of hour's surgery time(baseline)
- number of minutes use of the LASER during surgery(baseline)
- quantity of energy used during the intervention per patient(baseline)
- Duration of post-operative sounding (hours)(baseline)
- Mean change in IIEF-5 before surgery and 3 months after surgery(3 months after surgery)
- Mean change in ICIQ-short form score before surgery and 3 months after surgery(3 months after surgery)
- Mean change in USP before surgery and 3 months after surgery(3 months after surgery)