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

Results First Received: June 14, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Diagnostic
Condition:	Varicose Veins
Interventions:	Procedure: preoperative duplex examination Procedure: Preoperative duplex

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Varicose Vein Surgery With 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
Varicose Vein Surgery Without Preoperative Duplex	The surgeon has planned surgery for varicose veins from a clinical examination only

Participant Flow: Overall Study

	Varicose Vein Surgery With Preoperative Duplex	Varicose Vein Surgery Without Preoperative Duplex
STARTED	148 ^[1]	145 ^[2]
COMPLETED	113 ^[3]	108 ^[4]
NOT COMPLETED	35	37
Lost to Follow-up	35	37

[1]	166 legs total operated
[2]	177 legs total operated
[3]	127 legs
[4]	129 legs

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Varicose Vein Surgery With 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
Varicose Vein Surgery Without Preoperative Duplex	The surgeon has planned surgery for varicose veins from a clinical examination only
Total	Total of all reporting groups

Baseline Measures

	Varicose Vein Surgery With Preoperative Duplex	Varicose Vein Surgery Without Preoperative Duplex	Total
Number of Participants [units: participants]	148	145	293
Age [units: years] Mean ± Standard Deviation	56.3 ± 10.6	52.6 ± 12.9	54 ± 11
Gender [units: participants]
Female	108	109	217
Male	40	36	76
Region of Enrollment [units: participants]
Sweden	148	145	293

Outcome Measures

Show All Outcome Measures

1. Primary:

Rate of Re-do Surgery [ Time Frame: 7 years mean ]

Show Outcome Measure 1

2. Secondary:

Recurrence Rate [ Time Frame: 7 years ]

Show Outcome Measure 2

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:

Name/Title: Lena Blomgren MD PhD
Organization: Uppsala UH
phone: +46851774173
e-mail: lena.blomgren@karolinska.se

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. 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.

Responsible Party:	Lena Blomgren, Uppsala University Hospital
ClinicalTrials.gov Identifier:	NCT01195623 History of Changes
Other Study ID Numbers:	ETKI 96-169
Study First Received:	September 3, 2010
Results First Received:	June 14, 2012
Last Updated:	February 13, 2013
Health Authority:	Sweden: Regional Ethical Review Board

To Top