Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-06 @ 7:07 PM
Study NCT ID:
NCT05993793
Status:
COMPLETED
Last Update Posted:
2023-08-15
First Post:
2023-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Fototherapy in the Treatment of Fissure in Ano
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005401', 'term': 'Fissure in Ano'}], 'ancestors': [{'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-07', 'studyFirstSubmitDate': '2023-08-07', 'studyFirstSubmitQcDate': '2023-08-07', 'lastUpdatePostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete closure of the fissure', 'timeFrame': '15 days', 'description': 'It is estimated that the fototherapy will close completely the fissure in patients with fissure in ano.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fissure', 'ano', 'phototherapy'], 'conditions': ['Fissure in Ano']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* individuals with the diagnosis of anal fissure that accepted to participate as volunteers in the clinical trial\n\nExclusion Criteria:\n\n* individuals with pelvic inflammation\n* individuals who have been through surgical procedures\n* individuals who have relapse'}, 'identificationModule': {'nctId': 'NCT05993793', 'briefTitle': 'Use of Fototherapy in the Treatment of Fissure in Ano', 'organization': {'class': 'OTHER', 'fullName': 'Centro de Atenção ao Assoalho Pélvico'}, 'officialTitle': 'Use of Fototherapy in the Treatment of Fissura in Ano', 'orgStudyIdInfo': {'id': '53623621.0.0000.5544'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fototherapy', 'interventionNames': ['Device: Fototherapy']}], 'interventions': [{'name': 'Fototherapy', 'type': 'DEVICE', '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", 'armGroupLabels': ['Fototherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41825-000', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Instituto Patrícia Lordelo', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro de Atenção ao Assoalho Pélvico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}