Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-03-11 @ 3:21 PM
Study NCT ID:
NCT02017106
Status:
COMPLETED
Last Update Posted:
2019-07-26
First Post:
2013-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014648', 'term': 'Varicose Veins'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-24', 'studyFirstSubmitDate': '2013-12-15', 'studyFirstSubmitQcDate': '2013-12-15', 'lastUpdatePostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease specific QoL (AVVQ)', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Number of secondary procedures', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Varicose Veins'], 'conditions': ['Varicose Veins', 'Endovenous Laser Ablation', 'Phlebectomies']}, 'referencesModule': {'references': [{'pmid': '19283745', 'type': 'RESULT', 'citation': 'Carradice D, Mekako AI, Hatfield J, Chetter IC. Randomized clinical trial of concomitant or sequential phlebectomy after endovenous laser therapy for varicose veins. Br J Surg. 2009 Apr;96(4):369-75. doi: 10.1002/bjs.6556.'}]}, 'descriptionModule': {'briefSummary': 'Varicose veins of the leg often have superficial tributaries, which are often symptomatic and a major reason for coming to the doctor. When treating the main varicose vein inside the leg, some doctors prefer to remove these tributaries while others prefer to leave them. This trial aims to see if it is better to remove these veins at the time of the first laser procedure or better to leave them and only remove them when asked.', 'detailedDescription': 'Endovenous laser therapy (EVLT) for varicose veins is associated with high initial occlusion rates, minimal complications and low recurrence rates at 5 years. Randomized trials and meta-analyses have confirmed the efficacy of EVLT in comparison with surgery and other endovenous techniques. There is also evidence that it may be associated with early quality of life (QoL) benefits compared with surgery. The general efficacy of EVLT has therefore been demonstrated and current research focuses on refinement of the procedure. A fundamental question concerns the management of residual varicosities following truncal laser ablation. One approach is to leave these varicosities to regress untouched, minimizing the procedure time and surgical trauma6. This approach, however, is associated with a significant number of secondary and tertiary interventions (sclerotherapy and/or ambulatory phlebectomy). Another option is to combine in a single procedure ambulatory phlebectomy with initial truncal laser ablation (EVLTAP). The aim of this randomized controlled trial was to assess the advantages of performing ambulatory phlebectomy as a concomitant procedure to truncal laser ablation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary, symptomatic, unilateral varicose great saphenous veins (GSV), with isolated saphenofemoral junction (SFJ) incompetence and GSV reflux on venous duplex imaging,\n* perigenicular vein diameter exceeding 4 mm,\n* acceptance by the patient of a local anaesthetic procedure.\n\nExclusion Criteria:\n\n* saphenopopliteal, small saphenous or deep venous incompetence on duplex imaging\n* did not give consent to trial participation.'}, 'identificationModule': {'nctId': 'NCT02017106', 'acronym': 'EVLTAP', 'briefTitle': 'Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hull University Teaching Hospitals NHS Trust'}, 'officialTitle': 'Randomized Clinical Trial of Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins', 'orgStudyIdInfo': {'id': 'EVLTAP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Concomitant phlebectomies', 'description': 'Removal of varicose tributaries during Endovenous laser ablation', 'interventionNames': ['Procedure: Endovenous Laser ablation and concomitant phlebectomies', 'Procedure: Endovenous Laser ablation and sequential phlebectomies']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sequential Phlebectomies', 'description': 'Endovenous laser ablation only', 'interventionNames': ['Procedure: Endovenous Laser ablation and concomitant phlebectomies', 'Procedure: Endovenous Laser ablation and sequential phlebectomies']}], 'interventions': [{'name': 'Endovenous Laser ablation and concomitant phlebectomies', 'type': 'PROCEDURE', 'armGroupLabels': ['Concomitant phlebectomies', 'Sequential Phlebectomies']}, {'name': 'Endovenous Laser ablation and sequential phlebectomies', 'type': 'PROCEDURE', 'armGroupLabels': ['Concomitant phlebectomies', 'Sequential Phlebectomies']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HU32JZ', 'city': 'Hull', 'state': 'Humberside', 'country': 'United Kingdom', 'facility': 'Hull Royal Infirmary', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hull University Teaching Hospitals NHS Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}