Trial document




drksid header

  DRKS00009898

Trial Description

start of 1:1-Block title

Title

Postoperative compression therapy in varicose vein surgery - compression stocking vs. phlebologic compression bandage - effect on postoperative complications and patient satisfaction.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

SCOVED STUDY
(Stocking Vs. Compression Dressing In Postoperative Treatment Of Vein Diseases)

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

A treatment requiring varicose vein disease has been diagnosed. For this purpose, a surgical treatment with removal of the altered vein is necessary. This procedure is conducted either through an incision in the groin or in knee level. In this study the influence of postoperative compression therapy on the formation of postoperative complications and the patient's well-being as a function of different postoperative compressive follow-up treatments will be investigated and a reference should be made to your quality of life. To what extent the supply with compression stocking is superior to compression bandages is subject of this investigation.
There will be a random assignment to a group of two. This random arrangement is called randomization. Either you get after surgery a compression stocking, or the operated leg is wrapped in multiple layers with bandages.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The postoperative care of patients after vein surgery requires the installation of a phlebological compression bandage or a compression stocking. Without performing a compression treatment, the surgery on varicose veins of the lower extremities leads to pronounced hematoma with potential reduction of lymph flow, neurological complications caused by pressure on nerves and possibly also to muscular / arthrogenic complaints by hematoma migration into muscle compartments and joints. It can cause postoperative revisions of hematoma, wound infections and wound complications.
Adequate compression therapy is necessary. The type of compression therapy is controversial. It is possible to use elastic, multilayer bandages or compression stockings. But it lacks evidence of effectiveness of both compression variants, although the surgical intervention on varicose veins is one of the most frequently performed operations in Germany. Although surgical treatment is largely standardized but the postoperative treatment is not standardized.
The aim of this study is to evaluate to what extent postoperative compression using compression stockings is superior to compression wrapping.
Within the trial the surgical treatment is carried out in a standardized surgical technique. A follow-up of patients is provided after 1 week and 4-6 weeks.
Included are patients with saphenous vein stripping (V. s. magna / V. s. para), venous valve repair using eVp (extraluminal valvuloplasty) and exhairesis of the insufficient side branches.
In addition, a Quality Of Life-measurement (PRO-Patient Reported Outcome) by SQOR V questionnaire specifically for venous diseases, and clinical classifications by CEAP and VCSS will be made.
The physical examination and duplex ultrasound measurements are carried out within the framework of the follow-up checks after standardized examination protocol.
The time/duration of the applied compression will also be documented.
A movement protocol (ADL Activity Of Daily Life) shall be drawn up by the participants.The postoperative pain is recorded by VAS score.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00009898
  •   2016/02/09
  •   [---]*
  •   yes
  •   Approved
  •   15-6552-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1174-5074 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I83 -  Varicose veins of lower extremities
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Postoperative compression by compression stockings
  •   Postoperative compression by compression bandages
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Postoperative complications; Audit record sheet: a) hematoma, b) neurological complications, c) muscular, d) arthrogenic) or e) other complications; measured by clinical examination and questionnaire; Duplex sonography; Follow up after 1 week and 4-6 weeks;

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Duration of in-patient/out-patient stay; postoperative pain measured by VAS score; Quality of Life measured by SQOR-V-score; measured during follow up visit 1 week and 4-6 weeks

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2016/02/09
  •   930
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Indication for surgical treatment of varicose veins (V.s. magna or parva); valvuloplasty or exhairesis of side branches; signed informed consent

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

General exclusion criteria in vein surgery (sufficient valve closure, no evidence of mobile valve flap, vein diameter normal, no degenerative changes of the saphenous veins); Patients with leg ulcers (C6); Refusal of consent; Relevant coagulopathy; PAD with ABI (Ankle Brachial Index) <0.8; Patients with lymph- lipedema; known allergies to the compression material

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Capio Klinik im Park
    • Mr.  Dr.  Horst-Peter  Steffen 
    • Hagelkreuzstrasse 37
    • 40721  Hilden
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   02103-896-189
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Essen
    • Mr.  Priv.-Doz. Dr.  Ingo  Stoffels 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Capio Klinik im Park
    • Mr.  Dr.  Horst-Peter  Steffen 
    • Hagelkreuzstrasse 37
    • 40721  Hilden
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinik für Dermatologie, Venerologie und Allergologie Universitätsklinikum Essen
    • Mr.  Priv.-Doz. Dr.  Ingo  Stoffels 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Capio Klinik im Park
    • Mr.  Dr.  Horst-Peter  Steffen 
    • Hagelkreuzstrasse 37
    • 40721  Hilden
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   02103-896-189
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.