Prevention of Acute Voiding Difficulty After Radical Proctectomy for Rectal Cancer With Tamsulosin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Re-insertion rate of urinary catheter after removal
研究概览
简要总结
Various adrenergic blockers are used for acute voiding difficulty after proctectomy. Recently, a selective alpha5-adrenergic blocker, Tamsulosin has been reported to have benefit in reducing urinary symptom score and in reducing the rate of intermittent self-catheterization for patients with rectal cancer after radical proctectomy.
This study is to evaluate the efficacy of pharmacologic prevention to ameliorate the incidence of postoperative urinary dysfunction.
详细描述
Acute voiding difficulty is caused from damage to pelvic sympathetic nerve after rectal surgery, and usually resolved spontaneously within several months after the surgery. However, acute voiding difficulty results in prolonged insertion of urinary catheter and is associated risk for urinary tract infection. Various adrenergic blockers are used for acute voiding difficulty after proctectomy. Recently, a selective alpha5-adrenergic blocker, Tamsulosin has been reported to have benefit in reducing urinary symptom score and in reducing the rate of intermittent self-catheterization for patients with rectal cancer after radical proctectomy.
This study is to evaluate the efficacy of pharmacologic prevention to ameliorate teh incidence of postoperative urinary dysfunction.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 20-80 years old in general good health
- •Patient willing to participate in the study
- •Patient who understands and accepts to sign the informed consent form
- •Patient who received proctectomy for rectal cancer located 15 cm or less of the anal verge
排除标准
- •Documented problem of preoperative urinary dysfunction
- •Any post-surgery change in patient condition which requires insertion of urinary catheter after surgery
- •Past history of recurrent urinary tract infection or malignancy of urinary system organs
- •Past history of surgery for urinary system organs
- •Current administration of Finasteride or Dutasteride
- •Liver dysfunction (SGOT or SGPT 100 IU/L or more)
- •Kidney dysfunction (serum Creatinine 3mg/dl or more)
研究组 & 干预措施
2
oral administration of Tamsulosin
干预措施: Tamsulosin (Drug)
结局指标
主要结局
Re-insertion rate of urinary catheter after removal
时间窗: after removal of urinary catheter
次要结局
- Scores of IPSS (International Prostatic Symptom Score) and the results of uroflowmetry(at postoperative day 7)