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临床试验/NCT05993793
NCT05993793已完成不适用

Use of Fototherapy in the Treatment of Fissura in Ano

Centro de Atenção ao Assoalho Pélvico1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
Complete closure of the fissure

研究概览

简要总结

The eligible population consisted of individuals with anal fissure awaiting surgical intervention. Individuals aged 18 years or older were included, diagnosed with anal fissure and who voluntarily agreed to participate in the research. Those who had some pelvic inflammation and who had already undergone a surgical procedure and had recurrence were excluded from the studyThe selected individuals underwent a standardized anamnesis of the service, answered questionnaires on symptoms of intestinal constipation (Rome IV Criteria and the Bristol Scale), underwent a physical evaluation by a trained professional, and then began the application of the research protocol. The Antares brand Laser device was used for 3 sessions with an interval of 24 hours. The Visual Analogue Scale (VAS) was used before starting treatment, after the first and second sessions, and 1 week after the third session. In addition, at the end of the treatment, the closure, or not, of the lesion was verified, and the questionnaires performed prior to phototherapy were reapplied. The VAS assesses the patient's level of pain, which can be divided into mild pain (1-2), moderate pain (3-7), and severe pain (8-10). The Bristol Scale is based on the identification of the patient's consistency of stools, while types 1-2 correspond to constipation, 3-4 indicate normal intestinal rhythm, 5 indicate lack of fiber, and 6-7 correspond to diarrhea.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Treatment
盲法
None

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

  • •individuals with the diagnosis of anal fissure that accepted to participate as volunteers in the clinical trial

排除标准

  • •individuals with pelvic inflammation
  • •individuals who have been through surgical procedures
  • •individuals who have relapse

研究组 & 干预措施

Fototherapy

Experimental

干预措施: Fototherapy (Device)

结局指标

主要结局

Complete closure of the fissure

时间窗: 15 days

It is estimated that the fototherapy will close completely the fissure in patients with fissure in ano.

次要结局

未报告次要终点

研究者

发起方
Centro de Atenção ao Assoalho Pélvico
申办方类型
Other
责任方
Sponsor

研究点 (1)

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