Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2025-12-28 @ 6:25 AM
Study NCT ID:
NCT01701661
Status:
COMPLETED
Last Update Posted:
2012-10-05
First Post:
2012-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014689', 'term': 'Venous Insufficiency'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072700', 'term': 'Conservative Treatment'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-04', 'studyFirstSubmitDate': '2012-10-03', 'studyFirstSubmitQcDate': '2012-10-04', 'lastUpdatePostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom relief', 'timeFrame': 'two years', 'description': 'Patients are examined at the baseline, one and 2-year follow-up and the following measures are compared: clinical classification, venous disability score, venous disease severity score, reflux according to ultrasound examination.'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'two years', 'description': 'Quality of life is evaluated with two questionnaires: Aberdeen (which is a 13-item questionnaire with categories related specially to disadvantages caused by varicose veins) and 15D (a questionnaire with categories related to general quality of life).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['venous surgery', 'compression therapy'], 'conditions': ['Venous Insufficiency']}, 'descriptionModule': {'briefSummary': 'Randomized controlled trial, a method used to implement the random allocation sequence is numbered containers.\n\nThe aim of the study is to compare compression therapy with compression stockings and surgery eliminating superficial venous reflux in patients with duplex ultrasound verified superficial venous reflux without skin changes or ulceration.', 'detailedDescription': 'Superficial venous reflux is common in adult population. Uncomplicated disease, where there is no skin changes but varicose veins with or without leg swelling, can be totally asymptomatic but also cause various symptoms as pain, aching and discomfort of leg usually caused by increased venous pressure. Varicose veins may also cause cosmetic problem. Compression stockings relief the symptoms as they normalize venous pressure. In surgical treatment, axial reflux is treated usually by removing incompetent superficial veins. The aim of the study is to compare conservative treatment with compression stockings with surgical treatment of superficial venous reflux. In operative treatment the great saphenous vein or lesser saphenous vein are removed after flush ligation by femoral vein and stripping of the trunk. If the main trunk has been removes previously, axial refluating veins are removed or ligated according to the DUS finding. The patients in both groups are examined at the baseline and followed up to two years by ultrasound scanning. Patients clinical classification, venous disability score, venous disease severity score, anatomical path of reflux as well as quality of life are studied at the baseline, at one year follow-up and two years follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with chronic superficial vein insufficiency\n* patient must be 20-70 years old\n* degree of difficulty of vein insufficiency C2-C3\n* venous disability score 1-2\n* patient is agreeable to the study\n\nExclusion Criteria:\n\n* peripheral atherosclerotic occlusive disease\n* lymphoedema\n* severe concomitant disease (ASA 3-5)\n* venous ulcers or unclassified skin changes\n* BMI more than 35'}, 'identificationModule': {'nctId': 'NCT01701661', 'briefTitle': 'Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TYH4209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conservative treatment', 'description': 'Compression stockings class II', 'interventionNames': ['Other: conservative treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Operative treatment', 'description': 'stripping of main trunk or if previously removed, removal or ligating the refloating trunk', 'interventionNames': ['Procedure: Operative treatment']}], 'interventions': [{'name': 'Operative treatment', 'type': 'PROCEDURE', 'description': 'stripping of main trunk or if previously removed, removal or ligating the refluating trunk', 'armGroupLabels': ['Operative treatment']}, {'name': 'conservative treatment', 'type': 'OTHER', 'description': 'Compression stockings class II', 'armGroupLabels': ['conservative treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'state': 'HUS', 'country': 'Finland', 'facility': 'Department of Vascular Surgery, Helsinki University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Maarit Venermo, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Vascular Surgery, Helsinki University Central Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD,PhD', 'investigatorFullName': 'Maarit Venermo', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}