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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
ISRCTN ISRCTN48980066
DOI 10.1186/ISRCTN48980066
ClinicalTrials.gov identifier
EudraCT number
Public title First operation in the groin to treat varicose veins: a comparison of two different surgical techniques with regards to reducing lymphatic complications
Scientific title Primary surgery for saphenofemoral incompetence: a randomised controlled trial to compare two techniques to reduce lymphatic complications
Acronym N/A
Serial number at source N/A
Study hypothesis 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.
Lay summary
Ethics approval Ethics approval received from the Ethikkommission des Spital Thun STS AG (Switzerland) on the 1st December 2004 (ref: 3:16;27.9).
Study design Prospective randomised controlled trial
Countries of recruitment Switzerland
Disease/condition/study domain Saphenofemoral incompetence
Participants - inclusion criteria 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
Participants - exclusion criteria Previously operated groin by arterial or venous operation.
Anticipated start date 01/01/2005
Anticipated end date 30/06/2008
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Initial target was at least 100 patients and therefore at least 200 procedures
Interventions 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.
Primary outcome measure(s) 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.
Secondary outcome measure(s) 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).
Sources of funding Investigator initiated and funded (Switzerland)
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19736634
Contact name Dr  Wolfgang  Mouton
  Address Spital Thun STS AG
Department of Surgery
Krankenhausstrasse 12
  City/town Thun
  Zip/Postcode 3600
  Country Switzerland
Sponsor Spital Thun STS AG (Switzerland)
  Address Department of Surgery
Krankenhausstrasse 12
  City/town Thun
  Zip/Postcode 3600
  Country Switzerland
  Sponsor website: http://www.spitalstsag.ch
Date applied 01/07/2008
Last edited 19/10/2009
Date ISRCTN assigned 11/07/2008
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