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ISRCTN
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ISRCTN48980066
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DOI
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10.1186/ISRCTN48980066
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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First operation in the groin to treat varicose veins: a comparison of two different surgical techniques with regards to reducing lymphatic complications
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Scientific title
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Primary surgery for saphenofemoral incompetence: a randomised controlled trial to compare two techniques to reduce lymphatic complications
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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The aim of this study was to prospectively compare two surgical techniques in primary high ligation such as sharp dissection with ligation of lymphatic tissue versus dissection with electrocoagulation in regard to the incidence of lymphocoele and lymphatic fistula. It is exspected that maybe sharp dissection with ligation of lymphatic tissue shows less lymphatic complications and would be therefore to be recommended.
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Lay summary
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Ethics approval
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Ethics approval received from the Ethikkommission des Spital Thun STS AG (Switzerland) on the 1st December 2004 (ref: 3:16;27.9).
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Study design
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Prospective randomised controlled trial
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Countries of recruitment
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Switzerland
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Disease/condition/study domain
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Saphenofemoral incompetence
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Participants - inclusion criteria
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1. Pre-operative written consent
2. Adults (greater than 16 years), either sex
3. The patient had to be operated on both areas of the groin
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Participants - exclusion criteria
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Previously operated groin by arterial or venous operation.
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Anticipated start date
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01/01/2005
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Anticipated end date
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30/06/2008
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Initial target was at least 100 patients and therefore at least 200 procedures
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Interventions
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Patients get operated on for symptomatic varicose vein disease classified C2 to C6 according clinical, aetiological, anatomical, pathological elements (CEAP). The CEAP classification is the common standard for classification of venous disorders and is widely used. All patients included in the study had informed preoperative consent. 134 consecutive unselected patients underwent bilateral primary saphenous high ligation procedures during a period of three and half years. The patients were randomised to receive either sharp dissection with ligation of lymphatic tissue using absorbable suture material (Vicryl, Ethicon Endo-Surgery, Johnson and Johnson Company, Spreitenbach, Switzerland) or dissection with electrocoagulation (Elektrotom Berchtold GmbH&Co, Tuttlingen, Germany).
The groin was opened via a transverse incision. The long saphenous vein up to the femoral vein was visualised, side branches ligated and the long saphenous vein flush-ligated with absorbable suture material. After the stripping of the long saphenous vein no wound drain was inserted and subcutaneous tissue was closed in one layer. The skin was closed with intracutaneous sutures. The wound was observed for lymphatic fistula and formation of a lymphocoele.
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Primary outcome measure(s)
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The wound was observed for lymphatic fistula and formation of a lymphocoele. After one and ten days a clinical investigation was carried out to detect lymphatic complications.
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Secondary outcome measure(s)
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Further follow-up data were assessed by the means of the electronic patient record (EPR) (e.g., adverse events, complications, etc).
Statistical focus was on three parameters, all being defined in terms of a patient undergoing the two methods of operation:
p1 = probability of complications with method 1
p2 = probability of complications with method 2
p3 = probability of complications with just one of the two methods of operations
Differences were considered significant at an a level of 0.05, the software used was S-Plus Professional 6.2 (Insightful Corp., Seattle, USA).
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Sources of funding
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Investigator initiated and funded (Switzerland)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19736634
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Contact name
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Dr
Wolfgang
Mouton
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Address
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Spital Thun STS AG
Department of Surgery
Krankenhausstrasse 12
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City/town
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Thun
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Zip/Postcode
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3600
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Country
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Switzerland
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Sponsor
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Spital Thun STS AG (Switzerland)
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Address
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Department of Surgery
Krankenhausstrasse 12
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City/town
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Thun
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Zip/Postcode
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3600
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Country
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Switzerland
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Sponsor website:
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http://www.spitalstsag.ch
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Date applied
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01/07/2008
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Last edited
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19/10/2009
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Date ISRCTN assigned
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11/07/2008
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