Trial document





This trial has been registered retrospectively.
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  DRKS00008956

Trial Description

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Title

Are Drains necessary for mesh-augmented hernioplasty?

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Trial Acronym

BADEN

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In the reparation of an abdominal wall hernia with implantation of a reinforcing mesh, drainages are often used with the objective of avoiding fluid collections. Drainages can, however, cause pain and facilitate wound infections. To date, no studies have been carried out on the use of or against the introduction of drainages. This study aims to determine if it safe to avoid the use of drainages in smaller abdominal hernias.

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Brief Summary in Scientific Language

In the hernioplasty of ventral hernias with alloplastic augmentation, drainages are generally introduced into the rectal sheath and the subcutaneous tissue. No evidence exists so far. This feasibility study is designed to test the safety of the absence of drainage in small abdominal hernias, which are repared in sublay technique.

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Organizational Data

  •   DRKS00008956
  •   2017/07/24
  •   [---]*
  •   yes
  •   Approved
  •   F-2015-049, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K43 -  Ventral hernia
  •   T81.4 -  Infection following a procedure, not elsewhere classified
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Interventions/Observational Groups

  •   In the context of a ventral wall hernioplasty with sublay mesh implantation, no drainages in the mesh bearing/rectus sheath is used. The subcutaneous use of drains is allowed.
  •   Use of at least on Redon drainage (12Ch min.) in rectus sheath and subcutaneous tissue respectively.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Volume of fluid collection in the rectal sheath, sonographically measured at postoperative days 15 and 30.

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Secondary Outcome

length os hospital stay, unplanned readmission, reoperation, length of inability to work, pain (VAS-score), Mesh-associated complication (Dindo-Clavien classification)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/05/17
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

ventral hernia with a diameter of maximal 4cm, planned mesh-augmented hernioplasty in sublay-technique

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Exclusion Criteria

Refusal, coagulopathy, necessity of musculo-fascial mobilisation after Ramirez

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Addresses

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    • Klinik für Allgemein-, Viszeral- und ThoraxchirurgieMarienhospital Stuttgart
    • Böheimstr. 37
    • 70199  Stuttgart
    • Germany
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    • Klinik für Allgemein-, Viszeral- und ThoraxchirurgieMarienhospital Stuttgart
    • Mr.  Dr.  Julius  Pochhammer 
    • Böheimstr. 37
    • 70199  Stuttgart
    • Germany
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    • Klinik für Allgemein-, Viszeral- und ThoraxchirurgieMarienhospital Stuttgart
    • Mr.  Dr.  Julius  Pochhammer 
    • Böheimstr. 37
    • 70199  Stuttgart
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Allgemein-, Viszeral- und ThoraxchirurgieMarienhospital Stuttgart
    • Böheimstr. 37
    • 70199  Stuttgart
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/04/30
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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.