Primary surgery for saphenofemoral incompetence: a randomised controlled trial to compare two techniques to reduce lymphatic complications
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.
Ethics approval received from the Ethikkommission des Spital Thun STS AG (Switzerland) on the 1st December 2004 (ref: 3:16;27.9).
Prospective randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
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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.
Primary outcome measure
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 measures
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).
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant 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
Target number of participants
Initial target was at least 100 patients and therefore at least 200 procedures
Participant exclusion criteria
Previously operated groin by arterial or venous operation.
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Spital Thun STS AG
Spital Thun STS AG (Switzerland)
Department of Surgery
Investigator initiated and funded (Switzerland)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19736634
Mouton WG, Keller S, Naef M, Wagner HE, Primary surgery for sapheno-femoral incompetence: A randomised controlled trial to compare two techniques to reduce lymphatic complications., VASA, 2009, 38, 3, 234-237, doi: 10.1024/0301-15188.8.131.52.