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

NCT01195623 | Completed Results

• 1 other identifier: ETKI 96-169
• Study Type: interventional
• Target: 293
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicose Veins

Keywords

varicose veins; venous insufficiency; surgery; duplex; recurrence

Outcome Measures

Primary Outcomes (1)

• Rate of Re-do Surgery

  number of reoperations (legs) in the two treatment arms

  7 years mean

Secondary Outcomes (1)

• Recurrence Rate

  7 years

Study Arms (2)

varicose vein surgery with preop duplex

ACTIVE COMPARATOR

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

varicose vein surgery no preop duplex

NO INTERVENTION

The surgeon has planned surgery for varicose veins from a clinical examination only

Interventions

preoperative duplex examination PROCEDURE

varicose vein surgery with preop duplex

Preoperative duplex PROCEDURE

varicose vein surgery with preop duplex

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with primary varicose veins

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University Hospital: lead
• Capio Research Foundation: collaborator
• Region Stockholm: collaborator

Study Sites (1)

Capio StGörans Gospital

Stockholm, SE-11821, Sweden

Location

Related Publications (5)

• 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.

  PMID: 16378147 BACKGROUND

• 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.

  PMID: 16102633 BACKGROUND

• 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.

  PMID: 15810046 RESULT

• 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.

  PMID: 21618499 RESULT

• 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.

  PMID: 31992538 DERIVED

MeSH Terms

Conditions

Varicose Veins; Venous Insufficiency; Recurrence

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The rate of hand-held Doppler device use was not known and may have influenced the results, however even now many Swedish surgeons plan varicose vein surgery clinical tests only

Results Point of Contact

• Title: Lena Blomgren MD PhD
• Organization: Uppsala UH

lena.blomgren@karolinska.se

+46851774173

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 6, 2010
• Study Start: November 1, 1997
• Primary Completion: September 1, 2003
• Study Completion: August 1, 2010
• Last Updated: February 15, 2013
• Results First Posted: February 15, 2013

Record last verified: 2013-02

Locations

SE (1)