Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Wolfgang Mouton

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Primary surgery for saphenofemoral incompetence: a randomised controlled trial to compare two techniques to reduce lymphatic complications

Acronym

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Saphenofemoral incompetence

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

01/01/2005

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

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

01/01/2005

Recruitment end date

30/06/2008

Locations

Countries of recruitment

Switzerland

Trial participating centre

Spital Thun STS AG
Thun
3600
Switzerland

Sponsor information

Organisation

Spital Thun STS AG (Switzerland)

Sponsor details

Department of Surgery
Krankenhausstrasse 12
Thun
3600
Switzerland

Sponsor type

Hospital/treatment centre

Website

http://www.spitalstsag.ch

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19736634

Publication citations

  1. Results

    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: 10.1024/0301-1526.38.3.234.

Editorial Notes