跳至主要内容
临床试验/NCT04714684
NCT04714684Unknown不适用

The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia0 个研究点目标入组 100 人开始时间: 2021年2月10日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gian Luca Baiocchi

Prof.

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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