title: Pulmonary wedge resection plus parietal pleurectomy (WRPP) versus parietal pleurectomy (PP) for the treatment of recurrent primary pneumothorax (WOPP trial): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  For the surgical treatment of recurrent primary spontaneous pneumothoraces (rPSP) different operative therapies are applied to achieve permanent freedom from recurrence.
  
  
  METHODS
  This multicenter clinical trial evaluates the long-term results of two commonly applied surgical techniques for the treatment of rPSP. Based on the inclusion and exclusion criteria, and after obtaining the patients' informed consent, participants are randomized into the two surgical treatment arms: pulmonary wedge resection plus parietal pleurectomy (WRPP) or parietal pleurectomy alone (PP). Consecutively, all study participants will be followed up for two years to evaluate the surgical long-term effect. The primary efficacy endpoint is the recurrence rate of pneumothorax within 24 months after surgery. The calculated sample size is 360 patients (n = 180 per treatment arm) to prove superiority of one of the two treatments. So far, 22 surgical sites have submitted their declaration of commitment, giving the estimated number of participating patients.
  
  
  CONCLUSIONS
  A prospective randomized clinical trial has been started to compare two established surgical therapies to evaluate the long-term results regarding recurrence rates. Furthermore, cost of treatment, and influence on the perioperative morbidity and mortality as well as on quality of life are analyzed. If the study reveals equivalence for both surgical techniques, unnecessary pulmonary resections could be avoided.
  
  
  BACKGROUND
  ClinicalTrials gov: NCT01855464 , 06.05 2013.
authors.affiliation: Department of General, Visceral, Vascular and Thoracic Surgery, Surgical Regional Centre Berlin of CHIR-Net, Charité University Medicine Berlin, Campus Charité Mitte, Charitéplatz 1, 10117, Berlin, Germany. jens.neudecker@charite.de.
authors.forename: Jens
authors.initials: J
authors.lastname: Neudecker
authors.affiliation: Clinical Trial Center Würzburg (CTCW), University Hospital Würzburg, Josef-Schneider Strasse 2, 97080, Würzburg, Germany. malzahn_u@ukw.de.
authors.forename: Uwe
authors.initials: U
authors.lastname: Malzahn
authors.affiliation: Clinical Trial Center Würzburg (CTCW), University Hospital Würzburg, Josef-Schneider Strasse 2, 97080, Würzburg, Germany. E_Heuschma_P@ukw.de.
authors.forename: Peter
authors.initials: P
authors.lastname: Heuschmann
authors.affiliation: Coordinating Center for Clinical Studies (KKS), Charité, Augustenburger Platz 1, 13353, Berlin, Germany. uwe.behrens@charite.de.
authors.forename: Uwe
authors.initials: U
authors.lastname: Behrens
authors.affiliation: Department of Cardiothoracic Surgery, University Hospital Würzburg, Oberdürrbacher Strasse 6, 97080, Würzburg, Germany. Walles_T@ukw.de.
authors.forename: Thorsten
authors.initials: T
authors.lastname: Walles
mesh_terms: D000293:Adolescent; D000328:Adult; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D018572:Disease-Free Survival; D005260:Female; D005858:Germany; D017048:Health Care Costs; D006801:Humans; D008297:Male; D010994:Pleura / Q000601:surgery*; D011013:Pneumonectomy / Q000009:adverse effects / Q000191:economics / Q000401:mortality; D011030:Pneumothorax / Q000175:diagnosis / Q000191:economics / Q000401:mortality / Q000601:surgery*; D011446:Prospective Studies; D012008:Recurrence; D012107:Research Design; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult