Trial document




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  DRKS00014987

Trial Description

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Title

SINGLE-PORT VATS vs. 3-PORT-VATS LOBECTOMY/SEGMENTECTOMY FOR NON SMALL CELL LUNG CANCER PATIENTS. A RANDOMISED CLINICAL TRIAL INVESTIGATING PAIN INTENSITY AND POST THORACOTOMY PAIN-SYNDROME

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Trial Acronym

1-OR-3-PORT

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URL of the Trial

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Brief Summary in Lay Language

The trial investigates postoperative pain in patients with histologically or radiologicaly verified non small cell lung cancer who are indicated for video assisted thoracoscopic surgery and anatominal lung resection (lobectomy or segmentectomy).

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Brief Summary in Scientific Language

The trial investigates patients with histologically or radiologicaly verified non small cell lung cancer (NSCLC) in clinical UICC stage IA-IB who are indicated for video assisted thoracoscopic surgery (VATS) and anatominal lung resection (lobectomy or segmentectomy).
Goal of the study is to investigate and compare the postoperative pain intensity (NRS) and the rate of postthoracotomy pain syndrome 120 days after single-PORT-VATS-Lobectomy/Segmentcetomy and 3-PORT-VATS-Lobectomy/Segmentectomy.

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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

  •   DRKS00014987
  •   2018/07/16
  •   [---]*
  •   yes
  •   Approved
  •   74/2016, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  •   U1111-1217-4197 
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Health Condition or Problem studied

  •   C34.9 -  Malignant neoplasm: Bronchus or lung, unspecified
  •   pain after anatomical resection of lung cancer
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Interventions/Observational Groups

  •   Single-PORT-VATS-Lobectomy/Segmentectomy: anatomical resection of a pulmonary lobe or segment through a single PORT 4cm incision.
  •   3-PORT-VATS-Lobectomy/Segmentectomy: resection of a pulmonary lobe or segment using three incisions (one 4cm incision similar to arm 1 and two 1cm incisions) at the chest wall.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Intensity of pain according to nummeric rating scale (NRS) 120 days postoperatively.

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Secondary Outcome

Intensity of postoperative pain 5 days postoperatively.

Neuropathic pain assessment using the leeds score for neuropathic symptoms and signs (LANSS) 120 days after operation

Postoperative complications-rate

Comparison of operative data (surgery duration, intraoperative blood loss, chest tube duration,
Morfin-equivelant dosis of pain medication used until the 5th postoperative day)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/09/06
  •   134
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

age ≥ 18, NSLC in clinical stage IA-IB and indication for VATS-Lobectomy/Segmentectomy.

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Exclusion Criteria

preexisting pain (positive medical history or pain medication the last 3 months), emergency operations, positive history of thoracic operations ipsilateral, age under 18, non NSCLC.

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Addresses

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    • Thoraxchirurgie Lungenklinik MerheimKliniken der Stadt Köln GgmbH
    • Ostmerheimerstrasse 200
    • 51109  Cologne
    • Germany
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    •   0049 221 8907 8640
    •   0049 221 8907 3533
    •   [---]*
    •   [---]*
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    • Lungenklinik MerheimThoraxchirurgieKliniken der Stadt Köln
    • Mr.  Dr. med.  Aris  Koryllos 
    • Ostmerheimerstr. 200
    • 51109  Köln
    • Germany
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    • Lungenklinik MerheimTHoraxchirurgieKliniken der Stadt Köln
    • Mr.  Dr. med.  Aris  Koryllos 
    • Ostmerheimerstr. 200
    • 51109  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Thoraxchirurgie Lungenklinik MerheimKliniken der Stadt Köln GgmbH
    • Ostmerheimerstrasse 200
    • 51109  Cologne
    • Germany
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    •   0049 221 8907 8640
    •   0049 221 8907 3533
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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