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

• ClinicalTrials.gov Identifier: NCT01195623
• Recruitment Status: Completed
• First Posted: September 6, 2010
• Results First Posted: February 15, 2013
• Last Update Posted: February 15, 2013
• Sponsor: Uppsala University Hospital
• Collaborators: Capio Research Foundation; Region Stockholm
• Information provided by (Responsible Party): Lena Blomgren, Uppsala University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Varicose Veins	Procedure: preoperative duplex examination; Procedure: Preoperative duplex	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 293 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Randomized Clinical Trial of Routine Preoperative Duplex Imaging Before Varicose Vein Surgery; Long-term Follow-up
• Study Start Date: November 1997
• Actual Primary Completion Date: September 2003
• Actual Study Completion Date: August 2010

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: varicose vein surgery with preop duplex; The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail	Procedure: preoperative duplex examination; Procedure: Preoperative duplex
No Intervention: varicose vein surgery no preop duplex; The surgeon has planned surgery for varicose veins from a clinical examination only

Outcome Measures

Primary Outcome Measures :

1. Rate of Re-do Surgery [ Time Frame: 7 years mean ]
   number of reoperations (legs) in the two treatment arms

Secondary Outcome Measures :

1. Recurrence Rate [ Time Frame: 7 years ]
   number of recurrences in treatment arms but also nature of recurrences

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Sweden

Capio StGörans Gospital

Stockholm, Sweden, SE-11821

Sponsors and Collaborators

Uppsala University Hospital

Capio Research Foundation

Region Stockholm

More Information

Publications of Results:

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.

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.

Other Publications:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Lena Blomgren, MD, PhD, Uppsala University Hospital
• ClinicalTrials.gov Identifier: NCT01195623
• Other Study ID Numbers: ETKI 96-169
• First Posted: September 6, 2010
• Results First Posted: February 15, 2013
• Last Update Posted: February 15, 2013
• Last Verified: February 2013

Keywords provided by Lena Blomgren, Uppsala University Hospital:

varicose veins; venous insufficiency; surgery; duplex; recurrence

Additional relevant MeSH terms:

Varicose Veins; Vascular Diseases; Cardiovascular Diseases