Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-26 @ 7:44 AM
Study NCT ID:
NCT06079892
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemorrhoid Radiofrequency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2023-10-03', 'studyFirstSubmitQcDate': '2023-10-06', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of radiofrequency treatment efficiency', 'timeFrame': '3 months post procedure', 'description': 'Assessement of the procedure efficiency on prolapsus (using Goligher Score) and bleeding (using Haemorrhoidal bleeding score).\n\nProcedure is considered efficient when Goligher Score =1 AND HBS = 0'}], 'secondaryOutcomes': [{'measure': 'Measurement of patient satisfaction after surgery', 'timeFrame': '3 months post procedure', 'description': 'Patient will be asked :\n\n1. would you recommand this procedure to a friend ? (yes or no)\n2. Knowing your personnal outcome would you undergo the same procedure again ? (yes or no)\n\nPatients are considered satisfied by the procedure when they answered yes to at least one of the questions.'}, {'measure': 'Incidence rate of procedure complication', 'timeFrame': '3 months post procedure', 'description': 'incidence rate of haemorrhagic complication or acute urinary retention or other complication (such as post surgery abcess, localized infection, haematoma)'}, {'measure': 'description of procedure complication', 'timeFrame': '3 months post procedure'}, {'measure': 'Identification of predictive factor for success', 'timeFrame': '3 months post procedure', 'description': 'pre-procedure parameters will be correlated with procedure success (Goligher Score =1 AND HBS = 0 after procedure) in order to identify which factors give a higher chance of success'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['radiofrequency'], 'conditions': ['Hemorrhoid Prolapse']}, 'descriptionModule': {'briefSummary': 'Triapedicular haemorroidectomy is currently the gold standard in haemorrhoidal pathology. Minimally invasive surgical techniques now play an important role in the haemorrhoidal management algorithm, particularly for less advanced stages of the disease. Among these techniques, radiofrequency is one of the most recent and is gradually gaining ground. It involves applying a radiofrequency current to the internal haemorrhoidal tissue in order to induce its involution.\n\nThe literature has shown that this technique leads to symptomatic improvement in over 60% of cases and a high satisfaction rate, even though some patients still seem to have haemorrhoidal symptoms postoperatively.\n\nThe aim of this study is to evaluate the efficacy of this technique in patients with haemorrhoidal pathology operated on at our centre, using "hard" criteria which are thought to be more rigorous ("cure" rather than "improvement").'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient suffering for Haemorroidal pathology and requiring a removal procedure to whom a Radiofrequency procedure was performed', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years\n* Presence of haemorrhoidal pathology\n* Patient operated on between March 2017 and March 2023, using the radiofrequency technique\n* French-speaking patient\n\nExclusion Criteria:\n\n* ano-perineal involvement in Crohn's disease\n* perianal fistula\n* non-quiescent IBD\n* radiation-induced rectitis\n* psychiatric pathology.\n* under guardianship or curatorship\n* deprived of liberty\n* under court protection\n* Patient objecting to the use of his/her data for this research"}, 'identificationModule': {'nctId': 'NCT06079892', 'acronym': 'RFH', 'briefTitle': 'Hemorrhoid Radiofrequency', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Hôpital Saint-Joseph'}, 'officialTitle': 'Evaluation of Radiofrequency Efficiency in the Treatment of Hemorrhoid Pathology', 'orgStudyIdInfo': {'id': '647-AAM-RFH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'radiofrequency', 'type': 'PROCEDURE', 'description': 'haemorrhoidal removal using radiofrequency'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Amim Antonin Alam, MD', 'role': 'CONTACT', 'email': 'aalam@ghpsj.fr', 'phone': '+33144128694'}, {'name': 'Juliette COURTIADE MAHLER, phD', 'role': 'CONTACT', 'email': 'jcourtiade@ghpsj.fr', 'phone': '+33144127963'}, {'name': 'Amim Antonin Alam, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Vincent de Parades, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fondation Hôpital Saint Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Amine Antonin Alam, MD', 'role': 'CONTACT', 'email': 'aalam@ghpsj.fr', 'phone': '+331441286 94'}, {'name': 'Hélène BEAUSSIER, PharmaD, PhD', 'role': 'CONTACT', 'email': 'crc@ghpsj.fr', 'phone': '+33144127038'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}