Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases. Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 主要终点
- Pain symtom differences
研究概览
简要总结
New produced and patented sodium pantaborat based gel will be use for treatment of benign perianal diseases (hemooroidal disease, anal fissura anda perianal fistula)
详细描述
Prospective randomised clinical trial planned. Older than 18 years old perianal benign diseases (grade 1 and 2 hemorroidal disease, anal fissura, uncomplicated simple perianal fistula) cases without malign tumour, cronic colorectal disases, and routine used of vasoactive medication cases were entered the study. Younger than 18 years old, diagnosed any malign tumor and/or cronic colorectal disaeses, routine used of vasoact,ve mediaction cases were exclused of the study.
Group-1 (n: 50): Healthy cases (control group) Group-2 (n:50): Grade 1 hemorroidal disease cases Group-3 (n:50): Grade 2 hemorroidal disease cases Group-4 (n:50): Anal fissure cases Group-5 (n:50): Uncomplicated, simple perianal fistula cases
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade 1 and 2 hemorroidal disease
- •Cronic anal fissura
- •Uncomplicated simple perianal fistula
排除标准
- •Any malign tumour
- •Cronic colorectal disases
- •Routine used of vasoactive medication
研究组 & 干预措施
Group-1 (n: 50): Healthy cases
Control group
干预措施: Life7 (Drug)
Group-2 (n:50): Grade 1 hemorroid
With perianal examination diagnosed of grade 1 hemorroidal disease
干预措施: Life7 (Drug)
Group-3 (n:50): Grade 2 hemorroid
With perianal examination diagnosed of grade 2 hemorroidal disease
干预措施: Life7 (Drug)
Group-4 (n:50): Anal fissure cases
With perianal examination diagnosed of anal fissure cases
干预措施: Life7 (Drug)
Group-5 (n:50): Simple perianal fistula
With perianal examination diagnosed of uncomplicated, simple perianal fistula cases
干预措施: Life7 (Drug)
结局指标
主要结局
Pain symtom differences
时间窗: six months
Pain Scale from level 1 to level 10.
Lowering of the grade of the hemorroidal disease (hemoroidal disease is four grades; grade 1, grade 2, grade 3, and grade 4)
时间窗: six months
Surgeon general physical examination
Closing of anal fissur line
时间窗: six months
Surgeon general physical examination. Fissur line is exist or not exist
Lowering of leakage amount of perianal fistule
时间窗: six months
Three grade: lower, same, more
次要结局
未报告次要终点
研究者
Erhan Aysan
MD Prof
Yeditepe University