Trial document




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  DRKS00009865

Trial Description

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Title

Operations of varicose veins in TLA, general anesthesia and spinal anesthesia - effects on body temperature, healing, cardiac complications and hematoma and shivering

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Trial Acronym

PEHVO- Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Body temperature decreases during surgical Treatment. Patients can suffer of complications of low Body temperature. The study shows the development of body temperature during surgical treatment of varicose vein surgery, the posible complications are noticed.
Follow up examinations are planned after 1 and 4 weeks.

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Brief Summary in Scientific Language

The multicentric study records pre- and postoperative problems of patients during varicose vein surgery , the development of Body temperature and Patient reported outcome measures

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Organizational Data

  •   DRKS00009865
  •   2016/01/11
  •   [---]*
  •   yes
  •   Approved
  •   2014468, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

  •   U1111-1178-2600 
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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

  •   Operative Treatment in TLA with documentation of the body temperature and complications in the follow up
  •   Operative Treatment in TIVA with documentation of body temperature and complications in the follow up
  •   Operative Treatment in Spinal Anesthesia with documentation of body temperature and complications in the follow up.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Recording of body temperature in cases of different operative methods of treatment of varicose vein disease and different methods of anesthesia

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Secondary Outcome

Preoperative anamnestic data,
Preoperative CEAP-classification,
Measurement of pre-and intraoperative body temperature ,
Quality of life:
Documentation of VCSS-Score / SQOR-V-Score preoperative and in follow up 1 and 4 weeks postoperative

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2016/01/11
  •   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

Indications for the operative treatment of varicose vein disease of GSV and SSV by open surgery (stripping operation and miniphlebectomy ) and endovascular surgery (laser, radiofrequency ) ,
Age>18,
Preoperative duplex-sonographic examination

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Exclusion Criteria

Age<18
General exclusion criterias for varicose vein surgery ( normal vein diametre, no destruction of valves ),
Patients with venous ulcer ( CEAP 6 ),

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Capio Klinik im Park
    • Mr.  Dr. med.  Horst Peter  Steffen 
    • Hagelkreuzstrasse 37
    • 40721  Hilden
    • Germany
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    • Capio Klinik im Park
    • Mr.  Dr. med.  Horst Peter  Steffen 
    • Hagelkreuzstrasse 37
    • 40721  Hilden
    • Germany
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    • Capio Klinik im Park
    • Mr.  Dr. med.  Horst Peter  Steffen 
    • Hagelkreuzstrasse 37
    • 40721  Hilden
    • Germany
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Sources of Monetary or Material Support

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    • Capio Klinik im Park - Venenzentrum NRW
    • Mr.  Dr.med.   Horst Peter  Steffen 
    • Hagelkreuzstrasse 37
    • 40721  Hilden
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/07/15
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.