Clinical trial NCT01195623: The Long-term Value of Preoperative Duplex Before Surgery for Varicose Veins
Official title: Randomized Clinical Trial of Routine Preoperative Duplex Imaging Before Varicose Vein Surgery; Long-term Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Keywords: varicose veins
venous insufficiency
surgery
duplex
recurrence
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
Collaborators: name: Capio Research Foundation
name: Region Stockholm
First posted: 2010-09-06
Enrollment: 293
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of Re-do Surgery
timeFrame: 7 years mean
Secondary outcomes:
measure: Recurrence Rate
timeFrame: 7 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Capio StGörans Gospital
Study officials:
References:
citation: 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. doi: 10.1007/s10016-005-9285-z.
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. doi: 10.1016/j.jvs.2005.03.043.
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. doi: 10.1002/bjs.4983.
citation: Blomgren L, Johansson G, Emanuelsson L, Dahlberg-Akerman 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.
citation: Blomgren L. Residual incompetent tributaries after varicose vein surgery increased the need for reintervention after 8 years. J Vasc Surg Venous Lymphat Disord. 2020 May;8(3):378-382.e1. doi: 10.1016/j.jvsv.2019.11.012. Epub 2020 Jan 25.