Use of Fototherapy in the Treatment of Fissure in Ano

NCT05993793 | Completed DMC

• 1 other identifier: 53623621.0.0000.5544
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Fissure in Ano

Keywords

fissure; ano; phototherapy

Outcome Measures

Primary Outcomes (1)

• Complete closure of the fissure

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

  15 days

Study Arms (1)

Fototherapy

EXPERIMENTAL

Device: Fototherapy

Interventions

Fototherapy DEVICE

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

Fototherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centro de Atenção ao Assoalho Pélvico: lead

Study Sites (1)

Instituto Patrícia Lordelo

Salvador, Estado de Bahia, 41825-000, Brazil

Location

MeSH Terms

Conditions

Fissure in Ano

Condition Hierarchy (Ancestors)

Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 15, 2023
• Study Start: March 1, 2022
• Primary Completion: August 30, 2022
• Study Completion: December 20, 2022
• Last Updated: August 15, 2023

Record last verified: 2023-08

Locations

BR (1)