Trial document




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  DRKS00015486

Trial Description

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Title

A multicentre, prospective, controlled, clinical study to evaluate the impact of a synchronous treatment of the anterior accessory saphenous vein for prevention of recurrent varicose veins in patients undergoing thermal ablation of an insufficient great saphenous vein

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Trial Acronym

SYNCHRONOUS-Study

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URL of the Trial

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Brief Summary in Lay Language

Aim of this study is to evaluate if it is medically advisable to treat the anterior accessory saphenous vein at the same procedure than the great saphenous vein to prevent recurrent varicosis. Hitherto, there is only little known about the possible prevention by the simultaneous treatment of the anterior accessory saphenous vein.Therefore, the preventive ablation of the accessory saphenous vein is currently managed differently in each hospital or private practice. In this study patients undergoing thermal ablation of an insufficient great saphenous vein will be included. Depending on the routine medical care of the hospital or outpatient clinic the anterior accessory saphenous vein will be simultaneous treated or not. Over a time period of 5 years patients will be observed and the incidence of recurrent varicosis will be analyzed.

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Brief Summary in Scientific Language

To date, there are no controlled prospective studies available evaluating the impact of a simultaneous treatment of the anterior accessory saphenous vein for prevention of a secondary reflux in patients undergoing thermal ablation of an insufficient great saphenous vein. Nevertheless, both techniques are being equally performed according to the routine medical care of the clinic/outpatient clinic. Therefore, it remains unclear whether patients benefit from this procedure.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00015486
  •   2018/12/21
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  •   yes
  •   Approved
  •   S-596/2018, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   I83.9 -  Varicose veins of lower extremities without ulcer or inflammation
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Interventions/Observational Groups

  •   Synchronous thermal ablation of the anterior accessory saphenous vein (besides thermal ablation of the great saphenous vein) according to the routine medical care of the clinic/outpatient clinic.
  •   Thermal Ablation of ther great saphenous vein only, according to the Routine medical care of the clinic/outpatient clinic.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Rate of postoperative recurrent varicose (up to 5 years after the procedure)

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Secondary Outcome

complication rate, post-operative pain intensity, duration of absence from work and normal activity, disease-specific quality of life and patient satisfaction (up to 5 years after the procedure)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/01/01
  •   1000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

1. varicose veins (CEAP classification of C2)
2. Patients scheduled for thermal Ablation of a refluxing great saphenous vein
3. Patients ≥ 18 years of age
4. Written informed consent to participate in the study

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Exclusion Criteria

1. Great saphenous vein unsuitable for endovenous treatment
2. Patients with an incompetent anterior accessory saphenous vein

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Addresses

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    • Universitätsklinik HeidelbergHautklinik
    • Christine  Fink 
    • Im Neuenheimer Feld 440
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinik HeidelbergHautklinik
    • Christine  Fink 
    • Im Neuenheimer Feld 440
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinik HeidelbergHautklinik
    • Christine  Fink 
    • Im Neuenheimer Feld 440
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik HeidelbergHautklinik
    • Christine  Fink 
    • Im Neuenheimer Feld 440
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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