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ISRCTN
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ISRCTN23494731
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ClinicalTrials.gov identifier
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Public title
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Is the type of surgery in the groin influencing the coming back of varicose veins in the long term?
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Scientific title
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Surgery as a trigger for neorevascularisation in recurrent saphenofemoral incompetence: a randomised trial of three different techniques
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Surgery itself, and maybe the type of surgery, may trigger neorevascularistion in the groin when treating sapheno-femoral incompetence.The hypothesis is that one of the following three techniques is better - inducing less neorevascularisation - than the other two. If this would be the case this one technique should be preferred to the other two, worldwide.
The three techniques are:
1. Dissection under ligation
2. Dissection with electrocoagulation
3. Ultrasonic dissection
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Ethics approval
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Ethics Commission of the Regionalspital Thun approved on the 1st March 2002 (ref: 2:4;1.3)
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Study design
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Prospective randomised study
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Countries of recruitment
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Switzerland
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Disease/condition/study domain
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Recurrent varicose veins
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Participants - inclusion criteria
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1. Consecutive randomised patients with re-do surgery for sapheno-femoral incompetence in the groin
2. Written informed consent
3. Adults greater than 16 years old, either sex
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Participants - exclusion criteria
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Does not want to take part in the study
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Anticipated start date
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01/04/2002
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Anticipated end date
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01/06/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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36
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Interventions
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The study was approved by the local Human Ethics Committee. All patients included in the study have informed pre-operative consent. 36 consecutive unselected patients underwent redo saphenous high ligation procedures during a period of thirteen months (1st April 2002 - 30th June 2003).
The study population comprised 34 female patients and 2 males. The age ranged from 24 to 73 years (mean 53 years). Thirty-two patients had undergone at least one previous procedure in the groin. The patients were randomised to receive either dissection with ultrasound (Ultracision Harmonic Scalpel, Ethicon Endo-Surgery, Johnson and Johnson Company, Spreitenbach, Switzerland) or electrocoagulation (Elektrotom Berchtold GmbH&Co, Tuttlingen, Germany) or sharp dissection with ligation of scar and lymphatic tissue using absorbable suture material (Vicryl, Ethicon Endo-Surgery, Johnson and Johnson Company, Spreitenbach, Switzerland).
The groin was reopened via a transverse incision. The femoral artery was visualised as a landmark, after which the femoral vein was dissected and recurrent veins ligated and divided. Fascia and subcutaneous tissue was closed in two layers and included a vacuum wound drain. The skin was closed with sutures. Operating time is around one hour per procedure. The drain was removed one day post-operatively.
After three months a clinical and colour duplex ultrasonography investigation (Acuson Aspen, Acuson Corporation, Mountain View CA, USA) were carried out to detect lymphatic complications. After seven years a clinical and colour duplex ultrasonography investigation were carried out to detect and describe type and extent of neorevascularisation for the patients of all three treatment arms.
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Primary outcome measure(s)
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Clinical outcome and duplex sonography outcome at three months
VDS: venous disability score
VCSS: venous clinical severity score
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Secondary outcome measure(s)
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Clinical outcome and duplex sonography outcome at seven years
VDS: venous disability score
VCSS: venous clinical severity score
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Sources of funding
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Regionalspital Thun (Switzerland) - paying incidental costs
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Trial website
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Publications
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Contact name
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Dr
Wolfgang
Mouton
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Address
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Krankenhausstrasse 12
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City/town
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Thun
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Zip/Postcode
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3600
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Country
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Switzerland
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Sponsor
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Regionalspital Thun (Switzerland)
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Address
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Krankenhausstrasse 12
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City/town
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Thun
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Zip/Postcode
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3600
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Country
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Switzerland
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Date applied
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19/01/2010
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Last edited
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01/02/2010
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Date ISRCTN assigned
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01/02/2010
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