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

Primary Purpose

Varicose Veins

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
preoperative duplex examination
Preoperative duplex
Sponsored by
Uppsala University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Varicose Veins focused on measuring varicose veins, venous insufficiency, surgery, duplex, recurrence

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Capio StGörans Gospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

varicose vein surgery with preop duplex

varicose vein surgery no preop duplex

Arm Description

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

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

Outcomes

Primary Outcome Measures

Rate of Re-do Surgery
number of reoperations (legs) in the two treatment arms

Secondary Outcome Measures

Recurrence Rate
number of recurrences in treatment arms but also nature of recurrences

Full Information

First Posted
September 3, 2010
Last Updated
February 13, 2013
Sponsor
Uppsala University Hospital
Collaborators
Capio Research Foundation, Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT01195623
Brief Title
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

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
November 1997 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University Hospital
Collaborators
Capio Research Foundation, Region Stockholm

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins
Keywords
varicose veins, venous insufficiency, surgery, duplex, recurrence

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
293 (Actual)

8. Arms, Groups, and Interventions

Arm Title
varicose vein surgery with preop duplex
Arm Type
Active Comparator
Arm Description
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
Arm Title
varicose vein surgery no preop duplex
Arm Type
No Intervention
Arm Description
The surgeon has planned surgery for varicose veins from a clinical examination only
Intervention Type
Procedure
Intervention Name(s)
preoperative duplex examination
Intervention Type
Procedure
Intervention Name(s)
Preoperative duplex
Primary Outcome Measure Information:
Title
Rate of Re-do Surgery
Description
number of reoperations (legs) in the two treatment arms
Time Frame
7 years mean
Secondary Outcome Measure Information:
Title
Recurrence Rate
Description
number of recurrences in treatment arms but also nature of recurrences
Time Frame
7 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Capio StGörans Gospital
City
Stockholm
ZIP/Postal Code
SE-11821
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
16378147
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.
Results Reference
background
PubMed Identifier
16102633
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.
Results Reference
background
PubMed Identifier
15810046
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.
Results Reference
result
PubMed Identifier
21618499
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.
Results Reference
result
PubMed Identifier
31992538
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.
Results Reference
derived

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

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