Clinical Trials Directory

Trials / Completed

CompletedNCT05993793

Use of Fototherapy in the Treatment of Fissure in Ano

Use of Fototherapy in the Treatment of Fissura in Ano

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
10 (actual)
Sponsor
Centro de Atenção ao Assoalho Pélvico · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEFototherapyThe 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

Timeline

Start date
2022-03-01
Primary completion
2022-08-30
Completion
2022-12-20
First posted
2023-08-15
Last updated
2023-08-15

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT05993793. Inclusion in this directory is not an endorsement.