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
Protocol serial number	N/A
Sponsor	Spital Thun STS AG (Switzerland)
Funder	Investigator initiated and funded (Switzerland)

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

Primary study design	Interventional
Study design	Prospective randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Primary surgery for saphenofemoral incompetence: a randomised controlled trial to compare two techniques to reduce lymphatic complications
Study objectives	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(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) studied	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
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.
Key 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).
Completion date	30/06/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Key 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
Key exclusion criteria	Previously operated groin by arterial or venous operation.
Date of first enrolment	01/01/2005
Date of final enrolment	30/06/2008

Locations

Countries of recruitment

Switzerland

Study participating centre

Spital Thun STS AG

Thun
3600
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes