Use of Fototherapy in the Treatment of Fissure in Ano

Fissure in Ano Clinical Trial

Official title:

Use of Fototherapy in the Treatment of Fissura in Ano

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05993793
• Other study ID #: 53623621.0.0000.5544
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 20, 2022

Study information

• Verified date: August 2023
• Source: Centro de Atenção ao Assoalho Pélvico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 20, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Fissure in Ano

Intervention

Device:
• Fototherapy
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

Locations

Country	Name	City	State
Brazil	Instituto Patrícia Lordelo	Salvador	BA

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Atenção ao Assoalho Pélvico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete closure of the fissure	It is estimated that the fototherapy will close completely the fissure in patients with fissure in ano.	15 days