Prospective Assessment of Outcomes and Complications of Patients Submitted to Holmium Laser Enucleation of the Prostate (HoLEP) in a High Volume Center
试验速览
- 阶段
- 不适用
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Functional outcomes as assessed with IPSS questionnaire
研究概览
简要总结
The efficacy and safety of holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) have been comprehensively assessed. However, HoLEP is considered as a challenging procedure with a steep learning curve. As such, HoLEP is not as yet considered the gold standard for the surgical treatment of LUTS/BPH by international clinical guidelines.
The investigators aim to assess the complications and outcomes of patients treated with HoLEP by high volume surgeons, in order to provide data on the safety of the procedure and identify the profile of patients who may benefit from a dedicated clinical management to reduce the risk of post-operative complications.
详细描述
This is a prospective case-series study collecting data of patients treated with HoLEP at a single academic center. Patients submitted to surgery for bladder outlet obstruction (BOO) due to BPH will be consecutively included. All surgeries will be performed by two experienced surgeons with more than 1000 procedures performed (FM; GB).
Patients with neurological diseases and those with a history of previous surgery of the lower urinary tract (e.g. urethra and prostate surgery) will be excluded.
At the time of primary screening, all patients will be assessed with a comprehensive medical history; other pre-operative data will include: prostate volume (as assessed with trans-rectal prostate ultrasound); uroflowmetry parameters; total Prostate specific Antigen (PSA); baseline haemoglobin and creatinine level. Moreover, all patients will be invited to fill psychometric validated questionnaires assessing pre-operative urinary and sexual function, thus including: the International Prostatic Symptoms Score (IPSS); the International Index of Erectile Function (IIEF); the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF); and the Overactive Bladder Questionnaire (OABq). Moreover, urinary continence (UC) will be further assessed with a single question, and UC defined as no-pad use. Patients' medications will be also recorded.
Intra-operative data will be collected at the time of surgery, including: patients' systolic blood pressure; laser settings; enucleation efficiency (weight of enucleated tissue divided by lasing time) and morcellation efficiency (weight of enucleated tissue divided by morcellation time). Moreover, surgeons will be requested to provide a subjective estimation of the difficulty of the procedure with a 10-point Likert scale.
Post-operative data including: length of stay; timing of catheter removal and complications, will be also collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with lower urinary tract symptoms due to benign prostatic hyperplasia
排除标准
- •neurological diseases; previous surgery on the lower urinary tract (urethra/prostate)
结局指标
主要结局
Functional outcomes as assessed with IPSS questionnaire
时间窗: 12 months
functional urinary outcomes will be assessed with IPSS questionnaire at different time points over the first year after surgery.
次要结局
- Identification of clinical characteristics associated with risk of post-operative complications (recorded according to the Clavien-Dindo classification)(12 months)
研究者
Francesco Montorsi
Chairman Department of Urology IRCCS San Raffaele Hospital Professor of Urology Vita Salute San Raffaele University
IRCCS San Raffaele