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

Not Applicable

Completed

• Conditions: Varicose Veins
• Interventions: Procedure: preoperative duplex examination; Procedure: Preoperative duplex

• Registration Number: NCT01195623
• Lead Sponsor: Uppsala University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-11
• Primary Completion: 2003-09
• Study Completion: 2010-08
• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-03
• Study First Posted: 2010-09-06
• Results First Submitted: 2012-06-14
• Status Verified: 2013-02
• Results First Submitted QC: 2013-02-13
• Last Update Submitted: 2013-02-13
• Results First Posted: 2013-02-15
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 293

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
varicose vein surgery with preop duplex	preoperative duplex examination	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
varicose vein surgery with preop duplex	Preoperative 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

Primary Outcome Measures

Name	Time	Method
Rate of Re-do Surgery	7 years mean	number of reoperations (legs) in the two treatment arms

Secondary Outcome Measures

Name	Time	Method
Recurrence Rate	7 years	number of recurrences in treatment arms but also nature of recurrences

Trial Locations

Locations (1)

Capio StGörans Gospital; 🇸🇪 Stockholm, Sweden