Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Amount of Blood Loss During Monopolar transurethral resection of the prostate
研究概览
简要总结
This study aims to assess the role of intraprostatic injection of tranexamic acid in decreasing the blood loss during Transurethral resection of the prostate.
详细描述
Benign prostatic hyperplasia (BPH) is a process in which the pathology results in increased number of both stromal and epithelial cells in the area of the prostate around the urethra, which is pathologically known as hyperplasia, and not hypertrophy.
The accurate cause is not well known; however, "reactivation" of embryonic processes is one of the hypotheses that may cause benign prostatic hyperplasia (BPH). Benign prostatic hyperplasia (BPH) is a common condition that affects elderly men. Recently, many noninvasive and mini-invasive modalities have become popular for the management of men with voiding symptoms.
Transurethral resection of the prostate (TURP) is one of the most common and well-developed techniques used to treat benign prostatic hyperplasia (BPH), recognized as the 'gold standard' of the surgical treatments of enlarged prostates. The most relevant complications are the inability to void (5.8%), surgical revision (5.6%), urinary tract infection (UTI) (3.6%), bleeding requiring transfusions (2.9%), and Transurethral resection syndrome (1.4%). As the prostate has a rich blood supply, bleeding is one of the most common complications of Transurethral resection of the prostate.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient with an age between 50 and 85 years old
- •who had benign prostatic hyperplasia (aged 50-85 years) with a prostate weight of 50-80 g.
- •undergoing Transurethral resection of the prostate
排除标准
- •Patient refusal.
- •Patients hypersensitive to Tranexamic Acid, or on antiplatelet and anticoagulant drugs.
- •Patients with a history of thrombotic events, bleeding disorders, chronic kidney disease.
- •Patients with abnormal liver function test.
- •Patients with cardiovascular disease and receiving with a drug-eluting stent, bladder stone, urethral stricture, or with previous prostate surgery, prostate cancer, with a UTI or who receiving 5α-reductase inhibitors.
研究组 & 干预措施
Tranexamic Acid group
Patients in this group will receive 1 gm of Tranexamic Acid (Cyklokapron) that will be dissolved in 50 ml of injectable 0.9% saline
干预措施: Tranexamic Acid group (Drug)
Distilled water group
This group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine).
干预措施: Distilled water group (Drug)
结局指标
主要结局
Amount of Blood Loss During Monopolar transurethral resection of the prostate
时间窗: 2 weeks Postoperatively
The efficacy of intraprostatic injection of tranexamic acid in reducing intraoperative bleeding will be assessed in litter.
次要结局
- Hemoglobin (Hb) level(2 weeks Postoperatively)
- Hematocrit (HCT) Level(2 weeks Postoperatively)
- Postoperative hospital stay length(2 weeks Postoperatively)
研究者
Tamer Abd El-Wahab Diab
Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt
Benha University