Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:05 PM
Study NCT ID:
NCT00759434
Status:
COMPLETED
Last Update Posted:
2022-08-19
First Post:
2008-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A New Method of Surgically Treating Varicose Veins and Venous Ulcers - a Study to Assess Clinical and Economic Value
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014689', 'term': 'Venous Insufficiency'}, {'id': 'D014647', 'term': 'Varicose Ulcer'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-17', 'studyFirstSubmitDate': '2008-09-23', 'studyFirstSubmitQcDate': '2008-09-24', 'lastUpdatePostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Generic Quality of life - Short Form-36', 'timeFrame': '1 week, 6 weeks, 3 months, 1 year, 2 years'}], 'secondaryOutcomes': [{'measure': 'Disease Specific quality of life - Aberdeen Varicose Vein Questionnaire', 'timeFrame': '1 week, 6 weeks, 3 months, 1 year, 2 years'}, {'measure': 'Generic quality of life - EuroQol', 'timeFrame': '1 week, 6 weeks, 3 months, 1 year, 2 years'}, {'measure': 'Venous Clinical Severity Score', 'timeFrame': '3 months, 1 year, 2 years'}, {'measure': 'Visual analogue pain scores', 'timeFrame': '1 week'}, {'measure': 'Return to work and normal functioning', 'timeFrame': '1 week, 6 weeks'}, {'measure': 'Would undergo EVLT again if necessary', 'timeFrame': '1 week, 6 weeks, 3 months, 1 year, 2 years'}, {'measure': 'Complication rates', 'timeFrame': '1 week, 6 weeks, 3 months, 1 year, 2 years'}, {'measure': 'Duplex and clinical assessment', 'timeFrame': '1 week, 6 weeks, 3 months, 1 year, 2 years', 'description': 'A detailed clinical and duplex ultrasound assessment was undertaken to identify:\n\nThe presence of residual or recurrent varicose veins (defined as clinically evident varicose veins of greater than 3mm in diameter present at 1 and 6 weeks (residual) or becoming evident only after 6 weeks (recurrent). This was irrespective of the presence or absence of symptoms.\n\nThe pattern of underlying insufficiency on duplex giving rise to any clinically evident varicose veins or skin changes.'}, {'measure': 'Cost Effectiveness', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Varicose veins', 'Chronic venous insufficiency', 'Venous ulceration', 'Surgery', 'Endovenous Laser'], 'conditions': ['Varicose Veins', 'Venous Insufficiency', 'Venous Ulceration']}, 'referencesModule': {'references': [{'pmid': '16802211', 'type': 'BACKGROUND', 'citation': 'Mekako AI, Hatfield J, Bryce J, Lee D, McCollum PT, Chetter I. A nonrandomised controlled trial of endovenous laser therapy and surgery in the treatment of varicose veins. Ann Vasc Surg. 2006 Jul;20(4):451-7. doi: 10.1007/s10016-006-9095-y. Epub 2006 Jun 27.'}, {'pmid': '21638277', 'type': 'RESULT', 'citation': 'Carradice D, Mekako AI, Mazari FA, Samuel N, Hatfield J, Chetter IC. Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins. Br J Surg. 2011 Aug;98(8):1117-23. doi: 10.1002/bjs.7615. Epub 2011 Jun 3.'}, {'pmid': '21283981', 'type': 'RESULT', 'citation': 'Carradice D, Mekako AI, Mazari FA, Samuel N, Hatfield J, Chetter IC. Randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins. Br J Surg. 2011 Apr;98(4):501-10. doi: 10.1002/bjs.7394. Epub 2011 Jan 31.'}, {'pmid': '39162334', 'type': 'DERIVED', 'citation': 'Mohamed AH, Howitt A, Rae S, Cai PL, Hitchman L, Wallace T, Nandhra S, Pymer S, Knighton A, Smith G, Chetter IC, Carradice D. Ten-year outcomes of a randomized clinical trial of endothermal ablation versus conventional surgery for great saphenous varicose veins. Br J Surg. 2024 Aug 2;111(8):znae195. doi: 10.1093/bjs/znae195.'}, {'pmid': '30132797', 'type': 'DERIVED', 'citation': 'Wallace T, El-Sheikha J, Nandhra S, Leung C, Mohamed A, Harwood A, Smith G, Carradice D, Chetter I. Long-term outcomes of endovenous laser ablation and conventional surgery for great saphenous varicose veins. Br J Surg. 2018 Dec;105(13):1759-1767. doi: 10.1002/bjs.10961. Epub 2018 Aug 22.'}, {'pmid': '24424141', 'type': 'DERIVED', 'citation': 'Carradice D, Wallace T, Gohil R, Chetter I. A comparison of the effectiveness of treating those with and without the complications of superficial venous insufficiency. Ann Surg. 2014 Aug;260(2):396-401. doi: 10.1097/SLA.0000000000000541.'}, {'pmid': '20510634', 'type': 'DERIVED', 'citation': 'Carradice D, Mazari FA, Mekako A, Hatfield J, Allgar V, Chetter IC. Energy delivery during 810 nm endovenous laser ablation of varicose veins and post-procedural morbidity. Eur J Vasc Endovasc Surg. 2010 Sep;40(3):393-8. doi: 10.1016/j.ejvs.2010.04.010. Epub 2010 May 26.'}]}, 'descriptionModule': {'briefSummary': "Varicose veins are a common problem, affecting up to a third of the western adult population. Most suffer with aching, discomfort, pruritis, and muscle cramps, whilst complications include oedema, eczema, lipodermatosclerosis, ulceration, phlebitis, and bleeding. This is known to have a significant negative effect on patient's quality of life (QoL).\n\nSurgery has been used for many years, but it is known that there is a temporary decline in QoL post-op. This was demonstrated in our pilot study. Surgery leads to painful and prolonged recovery in some patients and has the risks of infection, haematoma and nerve injury.\n\nRecurrence rates are known to be significant. Duplex of veins post surgery has demonstrated persistent reflux in 9-29% of cases at 1 year, 13-40% at 2 years, 40% at 5 years and 60% at 34 years.\n\n26% of NHS patients were 'very dissatisfied' with their varicose vein surgery.\n\nNewer, less invasive treatments are being developed. It would be advantageous to find a treatment that avoided the morbidity of surgery, one that could be performed as a day-case procedure under a local anaesthetic, a treatment that could offer lower recurrence rates and allow an early return to work. These should be the aims of any new treatment for varicose veins.\n\nEndovenous Laser Treatment (EVLT) is performed under a local anaesthetic and uses laser energy delivered into the vein to obliterate it. The vein therefore need not be tied off surgically and stripped out.\n\nThe aim of this study is to compare the clinical, cost effectiveness and safety of Surgery and EVLT."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary, symptomatic, varicose veins.\n* Isolated Saphenofemoral junction (SFJ) incompetence leading to long saphenous (LSV) reflux on duplex ultrasound.\n* LSV of 4mm diameter at the knee.\n* Ability to give informed written consent.\n\nExclusion Criteria:\n\n* Inability to give informed written consent.\n* Symptomatic or complicated varicose veins not attributable to SFJ/LSV reflux.\n* Evidence of deep venous reflux on duplex scan.'}, 'identificationModule': {'nctId': 'NCT00759434', 'briefTitle': 'A New Method of Surgically Treating Varicose Veins and Venous Ulcers - a Study to Assess Clinical and Economic Value', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hull University Teaching Hospitals NHS Trust'}, 'officialTitle': 'A Dual Centre, Randomised Controlled Trial of the Clinical and Cost Effectiveness of Endovenous Laser Therapy (EVLT) in the Treatment of Varicose Veins and Venous Ulcers', 'orgStudyIdInfo': {'id': 'HELP1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Surgery', 'interventionNames': ['Procedure: Surgery - Saphenofemoral ligation, saphenous strip and avulsions']}, {'type': 'EXPERIMENTAL', 'label': 'EVLT', 'interventionNames': ['Procedure: EVLT']}], 'interventions': [{'name': 'Surgery - Saphenofemoral ligation, saphenous strip and avulsions', 'type': 'PROCEDURE', 'description': 'Patients undergo Saphenofemoral ligation, inversion stripping of the Long Saphenous Vein and avulsion of varicosities if necessary under a general anaesthetic.', 'armGroupLabels': ['Surgery']}, {'name': 'EVLT', 'type': 'PROCEDURE', 'description': 'Patients undergo endovenous laser treatment, using a 810nm laser aiming to occlude the incompetent long saphenous vein from the saphenofemoral junction to the knee. This may then be followed by ambulatory phlebectomy as appropriate. All procedures are to be performed under a local anaesthetic.', 'armGroupLabels': ['EVLT']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HU3 2JZ', 'city': 'Hull', 'state': 'East Yorkshire', 'country': 'United Kingdom', 'facility': 'Hull Royal Infirmary', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}], 'overallOfficials': [{'name': 'Ian C Chetter, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Hull'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hull University Teaching Hospitals NHS Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Hull', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}