Intra-Prostatic Epinephrine Injection in Bipolar Transurethral Resection of Large Prostate: Exploring Its Role in Optimizing Surgical Outcomes
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Intraoperative blood loss , need of blood transfusion
研究概览
简要总结
Intra-Prostatic Epinephrine injection in Bipolar Transurethral resection of large prostate: Exploring Its Role in Optimizing Surgical Outcomes
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
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Indication for Prostate Surgery or Procedure - Patients undergoing transurethral resection of the prostate (TURP)
- •Prostate from 80 to 100 gm
- •Failed medical therapy
排除标准
- •Uncontrolled Hypertension - Patients with significantly high blood pressure despite medication therapy.
- •Unstable angina, recent myocardial infarction, arrhythmias, or severe heart failure.
- •Significant Coagulopathy - Patients with bleeding disorders or on anticoagulants where excessive vasoconstriction may lead to tissue necrosis or inadequate perfusion
- •Hyperthyroidism, Pheochromocytoma or Endocrine Disorders - Patients with catecholamine-secreting tumors or other conditions that can lead to excessive sympathetic stimulation.
- •Treatment in the last 3 months with 5-alpha reductase inhibitors.
- •Genitourinary cancer, urinary tract lithiasis, and urological surgery within the last 3 months
研究组 & 干预措施
Epinephrine injection
Intra-Prostatic Epinephrine injection in Bipolar Transurethral resection of large prostate
干预措施: Epinephrine (Drug)
结局指标
主要结局
Intraoperative blood loss , need of blood transfusion
时间窗: 24h post operative
assessment of Blood Loss (Irrigation Fluid Hb Concentration): Bladder irrigation will be maintained for 24 hours post operatively, with fluid collections made at three intervals: Immediately postsurgery (V1), 6 hours postoperation (V2), and 24 hours postoperation (V3). The total volume collected will be measured, and 5000U of heparin will be added to each irrigation fluid container to prevent coagulation. After thorough mixing, 5-mL samples will be extracted and analyzed using cyanide met hemoglobin spectrophotometry at 540 nm to determine the Hb concentration. Blood loss will be estimated using specific formulas: (1) Hb concentration in irrigation fluid (g/L) = absorbance of fluid × 367.7; (2) Bleeding volume (mL) = (Hb concentration in irrigation fluid (g/L) × rinse volume (mL)) / preoperative Hb concentration(g/L).
次要结局
- Prostate volume , post voiding residual urine(3 months)
研究者
Ahmed Abdelraouf Saad
urology resident , urology department, Principal Investigator , benha university
Benha University