Trial document




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  DRKS00008194

Trial Description

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Title

Video-assisted thoracoskopic wedge resection of the lung without chest tube placement; a prospective randomized study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

We will examine the postoperative course after video-assisted thoracoscopic surgery with wedge resection from the Lung with and without placement a chest tube

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Organizational Data

  •   DRKS00008194
  •   2015/05/26
  •   [---]*
  •   yes
  •   Approved
  •   23302/2015/65, Ethikkommission der Landesärztekammer Thüringen
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Secondary IDs

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Health Condition or Problem studied

  •   J84.9 -  Interstitial pulmonary disease, unspecified
  •   R91 -  Abnormal findings on diagnostic imaging of lung
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Interventions/Observational Groups

  •   video-assisted thoracoscopic surgery with wedge resection from the Lung without placement a chest tube at the End the operation
  •   video-assisted thoracoscopic surgery with wedge resection from the Lung with placement a chest tube at the End the operation
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Duration of postoperative hospital stay

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Secondary Outcome

postoperative pain, postoperative pneumothorax, postoperative pleural effusion, postoperative chest tubes lay.
We will measure the postoperativ Pain with the visual Pain-scala, How much we need to give (Novamin, Dididolor), The duration of the Drainage. How much we need to lay a new Drainage. at the 7 Day after the Operation ambulant Rö-Thorax.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2015/06/01
  •   74
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   17   Years
  •   85   Years
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Additional Inclusion Criteria

all VATS-operations with wedge-resection from the lungs

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Exclusion Criteria

pulmonary nodule bigger than 3 cm, The nodule-location in the lung deeper than its diameter below the visceral pleura, more than 2 wedge-resections, interoperative conversion of thoracotomy, vats-lobectomy, lung volume reduction operations, bullectomy, peroperative pleural effusion, preoperative pneuthorax, pleural empyema, pleurodesis, intraoperativ visceral pleura injury,intraoperativ air fistula( under water-test), postoperative air leak more than 100ml/h under suction from minus 20 cm water head, thorax trauma

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Addresses

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    • SRH-Waldklinikum Gera
    • Straße des Friedens 122,
    • 07548  Gera
    • Germany
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    • SRH-Waldklinikum Gera
    • Mr.  PD Dr. med. habil  Thomas  Lesser 
    • Straße des Friedens 122,
    • 07548  Gera
    • Germany
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    • SRH-Waldklinikum Gera
    • Mr.  PD Dr. med. habil  Thomas  Lesser 
    • Straße des Friedens 122,
    • 07548  Gera
    • Germany
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Sources of Monetary or Material Support

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    • SRH-Waldklinikum Gera
    • Straße des Friedens 122,
    • 07548  Gera
    • Germany
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Status

  •   Recruiting planned
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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.