Loop Diuretics During Morcellation to Improve Same-day Discharge Rates After Holmium Laser Enucleation of the Prostate (HoLEP)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Same-day discharge
研究概览
简要总结
Holmium Laser Enucleation of the Prostate (HoLEP) is a size-independent treatment option for benign prostatic hypertrophy (BPH) as recommended by the American Urological Association (AUA) Guidelines. Loop diuretics (furosemide) have been given historically during the morcellation portion of HoLEP to promote urine production in the post-operative setting and to minimize the impact of fluid absorption during long periods of morcellation. The intra-operative use of 20mg IV furosemide in perioperative HoLEP pathways has been propagated with the dissemination of HoLEP across North America without evidence to support its routine administration. With increasing surgical efficiency from improvements in laser and morcellator technology, the role of intra-operative furosemide is unknown. This study is designed to assess if there is a significant difference in same day discharge rates after Holmium Laser Enucleation of the Prostate (HoLEP) with and without IV furosemide. .
详细描述
Holmium Laser Enucleation of the Prostate (HoLEP) is a size-independent treatment option for benign prostatic hypertrophy (BPH) as recommended by the American Urological Association (AUA) Guidelines. Loop diuretics (furosemide) have been given historically during the morcellation portion of HoLEP to promote urine production in the post-operative setting and to minimize the impact of fluid absorption during long periods of morcellation. The intra-operative use of 20mg IV furosemide in perioperative HoLEP pathways has been propagated with the dissemination of HoLEP across North America without evidence to support its routine administration.
This single-center randomized controlled trial is designed to assess if there is a significant difference in same day discharge rates after Holmium Laser Enucleation of the Prostate (HoLEP). We currently attempt to perform HoLEP as a same-day discharge (SDD) procedure, however one of the main limiting factors in SDD is hematuria. Loop diuretics (furosemide) have been administered at the time of morcellation as a part of our HoLEP pathway to increase post-operative urinary output and reduce clinically significant gross hematuria and clot-formation. The objective of our study will be to assess if SDD rates are non-inferior in those patients who do not receive furosemide diuretics versus those that do.
Patients will be randomized 1:1 to 20mg of IV lasix versus control. Patients and the surgeon/post-operative care team (fellow, residents, and nursing team) will be blinded to the treatment allocation.
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 (Participant, Care Provider)
盲法说明
Only the clinical investigator and anesthesiologist/nurse anesthetist will be aware of treatment allocation. The care providers (surgeon, fellow, resident, and nursing team) and patient will be blinded to the treatment allocation. The outcomes assessor will be unblinded at the time of statistical analysis.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males 18 -89 undergoing HoLEP
- •Willing to sign the Informed Consent Form
- •Able to read, understand, and complete patient questionnaires.
排除标准
- •Allergy or hypersensitivity to furosemide or other loop diuretic
- •Anuric patients or patients with liver failure
- •Patients having a concurrent ureteroscopy +/- laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at the time of their HoLEP
- •Anticipated need for perineal urethrostomy at the time of HoLEP
- •Patient not undergoing catheter removal and voiding trial at Northwestern Memorial Hospital
研究组 & 干预措施
Loop Diuretic (Furosemide)
This group of patients will receive 20mg of IV furosemide during the morcellation phase of their HoLEP.
干预措施: Furosemide (Drug)
结局指标
主要结局
Same-day discharge
时间窗: 90-days
Rate of successful same-day discharge after HoLEP
Same-day catheter removals
时间窗: 90-days
Rate of successful same-day catheter removals after HoLEP
次要结局
- Adverse medical events (hematuria)(90-days)
- Adverse medical events (fluid absorption)(90-days)
- Overall complications(90-days)
- Duration of post-operative hematuria(90-days)
- Length of hospital stay(90-days)
- Difference in operative efficiency (enucleation, morcellation, and overall)(90-days)
研究者
Amy Krambeck
Director of The Division of Endourology & Stone Disease
Northwestern University