The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- need of invasive treatment
研究概览
简要总结
Evaluate the effectiveness of fitostimoline proctogel in the anal fissure healing and in the need for invasive interventions (primary endpoints) and in the healing of the fissure (secondary endpoint) using Fitostimoline in addition to or without other topical devices available on the market.
Three groups will be established: one for the exclusive use of fitostimoline, the second for the use of fitostimoline in addition to one of the other topical devices already on the market and the third group only for the use of other topical therapies.
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
- Single (Investigator)
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
- •None previous therapies for anal fissure
- •Symptomatic anal fistula
- •Signing of informed consent
- •age >18 years old
排除标准
- •Patients unable to complete the questionnaire and with a legal guardian.
- •Patients with concomitant abscess/fistula
- •Pregnant women
结局指标
主要结局
need of invasive treatment
时间窗: 30 days
Anal dilatation, lateral internal sphincterotomy
control of anal fissure symptoms
时间窗: 30 days
pain relief (by using the NRS scale from 0 to 10 (0=absence of pain 10= maximum presence of pain) which should be lower than 3)
次要结局
- anal fissure healing(30 days)
研究者
Gian Luca Baiocchi
Prof.
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia