Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 9:47 PM
Study NCT ID:
NCT03322527
Status:
COMPLETED
Last Update Posted:
2018-02-27
First Post:
2017-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Technique LHP (Laser HemorrhoidoPlasty) in Haemorrhoidal Prolapse Mini Invasive Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006484', 'term': 'Hemorrhoids'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-26', 'studyFirstSubmitDate': '2017-10-24', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Goligher score', 'timeFrame': '1 year', 'description': 'score evaluating symptoms of haemorroidal pathology'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemorrhoids']}, 'descriptionModule': {'briefSummary': 'Hemorrhoids surgery technics evolved during the past 20 years. Recently a new one using laser have been developped. It aims at reducing the blood flow towards hemorroïdal plexuses by photocoagulating with a fiber laser the terminal branches of the superior rectal artery.\n\nThe aim is to evaluate the efficacy of this technic and note the post surgery pain and events'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patient with a haemorroid proloapse surgery programmed in GHPSJ', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18\n* hemorrhoid prolapse grade 2 and 3\n* accepting participation\n\nExclusion Criteria:\n\n* hemorrhoid prolapse grade 1 and 4\n* other proctological pathology\n* previous surgery of prolapsus\n* with anti coagulant treatment\n* Intestinal chronic inflammatory disease\n* age \\< 18\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT03322527', 'briefTitle': 'Evaluation of the Technique LHP (Laser HemorrhoidoPlasty) in Haemorrhoidal Prolapse Mini Invasive Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Hôpital Saint-Joseph'}, 'officialTitle': 'Evaluation of the Technique LHP (Laser HemorrhoidoPlasty) in Haemorrhoidal Prolapse Mini Invasive Surgery Grade II or III of Goligher', 'orgStudyIdInfo': {'id': 'HLASER'}}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Groupe Hospitalier Paris Saint Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'DE PARADES Vincent, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GHPSJ'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}