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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN48980066
Enrollment
100
Registered
2008-07-11
Start date
2005-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Saphenofemoral incompetence Circulatory System Varicose veins of lower extremities

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 sta

Sponsors

Spital Thun STS AG (Switzerland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Previously operated groin by arterial or venous operation.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026