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

This study has been completed.

Sponsor:

Collaborators:

Capio Research Foundation

Stockholm County Council, Sweden

Information provided by (Responsible Party):

Lena Blomgren, Uppsala University Hospital

ClinicalTrials.gov Identifier:

NCT01195623

First received: September 3, 2010

Last updated: February 13, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	September 3, 2010
Last Updated Date	February 13, 2013
Start Date ^ICMJE	November 1997
Primary Completion Date	September 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 13, 2013)	Rate of Re-do Surgery [ Time Frame: 7 years mean ] [ Designated as safety issue: No ] number of reoperations (legs) in the two treatment arms
Original Primary Outcome Measures ^ICMJE (submitted: September 3, 2010)	Rate of re-do surgery [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01195623 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 13, 2013)	Recurrence Rate [ Time Frame: 7 years ] [ Designated as safety issue: No ] number of recurrences in treatment arms but also nature of recurrences
Original Secondary Outcome Measures ^ICMJE (submitted: September 3, 2010)	recurrence rate [ Designated as safety issue: No ] number of recurrences in treatment arms but also nature of recurrences
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Long-term Value of Preoperative Duplex Before Surgery for Varicose Veins
Official Title ^ICMJE	Randomized Clinical Trial of Routine Preoperative Duplex Imaging Before Varicose Vein Surgery; Long-term Follow-up
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Varicose Veins
Intervention ^ICMJE	Procedure: preoperative duplex examination Procedure: Preoperative duplex
Study Arm (s)	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 Interventions: 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
Publications *	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. Epub 2011 May 27. 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	293
Completion Date	August 2010
Primary Completion Date	September 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	20 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Sweden

Administrative Information
NCT Number ^ICMJE	NCT01195623
Other Study ID Numbers ^ICMJE	ETKI 96-169
Has Data Monitoring Committee	No
Responsible Party	Lena Blomgren, Uppsala University Hospital
Study Sponsor ^ICMJE	Uppsala University Hospital
Collaborators ^ICMJE	Capio Research Foundation Stockholm County Council, Sweden
Investigators ^ICMJE	Not Provided
Information Provided By	Uppsala University Hospital
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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