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 https://doi.org/10.1186/ISRCTN48980066
Secondary identifying numbers N/A
Submission date
01/07/2008
Registration date
11/07/2008
Last edited
19/10/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Wolfgang Mouton
Scientific

Spital Thun STS AG
Department of Surgery
Krankenhausstrasse 12
Thun
3600
Switzerland

Study information

Study designProspective randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePrimary surgery for saphenofemoral incompetence: a randomised controlled trial to compare two techniques to reduce lymphatic complications
Study objectivesThe 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(s)Ethics approval received from the Ethikkommission des Spital Thun STS AG (Switzerland) on the 1st December 2004 (ref: 3:16;27.9).
Health condition(s) or problem(s) studiedSaphenofemoral incompetence
InterventionPatients 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.
Intervention typeOther
Primary outcome measureThe 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 measuresFurther 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 study start date01/01/2005
Completion date30/06/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsInitial target was at least 100 patients and therefore at least 200 procedures
Key inclusion criteria1. 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
Key exclusion criteriaPreviously operated groin by arterial or venous operation.
Date of first enrolment01/01/2005
Date of final enrolment30/06/2008

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Spital Thun STS AG
Thun
3600
Switzerland

Sponsor information

Funders

Funder type

Other

Investigator initiated and funded (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2009 Yes No
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