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Use of Fototherapy in the Treatment of Fissure in Ano

Primary Purpose

Fissure in Ano

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Fototherapy
Sponsored by
Centro de Atenção ao Assoalho Pélvico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fissure in Ano focused on measuring fissure, ano, phototherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Patrícia Lordelo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fototherapy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 7, 2023
Last Updated
August 7, 2023
Sponsor
Centro de Atenção ao Assoalho Pélvico
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1. Study Identification

Unique Protocol Identification Number
NCT05993793
Brief Title
Use of Fototherapy in the Treatment of Fissure in Ano
Official Title
Use of Fototherapy in the Treatment of Fissura in Ano
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro de Atenção ao Assoalho Pélvico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fissure in Ano
Keywords
fissure, ano, phototherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fototherapy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Fototherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Complete closure of the fissure
Description
It is estimated that the fototherapy will close completely the fissure in patients with fissure in ano.
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Instituto Patrícia Lordelo
City
Salvador
State/Province
BA
ZIP/Postal Code
41825-000
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Use of Fototherapy in the Treatment of Fissure in Ano

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