The Long-term Value of Preoperative Duplex Before Surgery for Varicose Veins

Varicose Veins Clinical Trial

Official title:

Randomized Clinical Trial of Routine Preoperative Duplex Imaging Before Varicose Vein Surgery; Long-term Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195623
• Other study ID #: ETKI 96-169
• Status: Completed
• Phase: N/A
• First received: September 3, 2010
• Last updated: February 13, 2013
• Start date: November 1997
• Est. completion date: August 2010

Study information

• Verified date: February 2013
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

Duplex imaging is costly and time-consuming, but is used increasingly for preoperative evaluation of varicose veins. Its value in terms of the long-term results of surgery is not clear. 293 patients (343 limbs) with primary varicose veins were randomized to operation with or without preoperative duplex imaging. Reoperation rates, clinical and duplex findings were compared at 2 months and 2 years after surgery. Routine preoperative duplex examination led to an improvement in results. However two years is a short time, and with a longer follow-up other mechanisms for recurrence may become more important, e.g. neovascularization (new vessel formation) or progression of disease, hence the value of a detailed preoperative diagnosis may be diminished. The aim of this phase of the investigation is to study the results after 8 years, in particular what mechanisms for recurrences were most important.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: August 2010
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients with primary varicose veins

Exclusion Criteria:

• pure cosmetic complaints

• previous venous surgery or sclerotherapy

• history of suspect or manifest deep venous thrombosis

• active or healed venous ulceration

• peripheral arterial disease

• previous significant trauma to the leg

• general illness

• alcohol or drug abuse

• unable to understand information

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Varicose Veins

Intervention

Procedure:
• preoperative duplex examination

• Preoperative duplex

Locations

Country	Name	City	State
Sweden	Capio StGörans Gospital	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Uppsala University Hospital	Capio Research Foundation, Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Blomgren L, Johansson G, Bergqvist D. Quality of life after surgery for varicose veins and the impact of preoperative duplex: results based on a randomized trial. Ann Vasc Surg. 2006 Jan;20(1):30-4. — View Citation

Blomgren L, Johansson G, Bergqvist D. Randomized clinical trial of routine preoperative duplex imaging before varicose vein surgery. Br J Surg. 2005 Jun;92(6):688-94. — View Citation

Blomgren L, Johansson G, Dahlberg-Akerman A, Thermaenius P, Bergqvist D. Changes in superficial and perforating vein reflux after varicose vein surgery. J Vasc Surg. 2005 Aug;42(2):315-20. — View Citation

Blomgren L, Johansson G, Emanuelsson L, Dahlberg-Åkerman A, Thermaenius P, Bergqvist D. Late follow-up of a randomized trial of routine duplex imaging before varicose vein surgery. Br J Surg. 2011 Aug;98(8):1112-6. doi: 10.1002/bjs.7579. Epub 2011 May 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Re-do Surgery	number of reoperations (legs) in the two treatment arms	7 years mean	No
Secondary	Recurrence Rate	number of recurrences in treatment arms but also nature of recurrences	7 years	No