Wedge Resection or Parietal Pleurectomy for the Treatment of Recurrent Pneumothorax (WOPP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Wuerzburg University Hospital
Sponsor:
Collaborators:
German Research Foundation
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Wuerzburg University Hospital
ClinicalTrials.gov Identifier:
NCT01855464
First received: May 6, 2013
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

Primary spontaneous pneumothoraces (PSP) represent a significant public health problem, occurring in young healthy subjects without pre-existing lung disease or precedent medical intervention or trauma with a reported incidence of up to 18-28/100 000 per year. PSP treatment often requires thoracic surgery to restore lung expansion and to prevent de novo lung collapse. Despite the presence of elaborated guidelines by the British Thoracic Society (BTS) postulating apical wedge resection of the lung and total parietal pleurectomy (WRPP), the majority of German hospitals gathered experience especially in limiting surgery to cost-saving partial apical parietal pleurectomy or yet apical pleural abrasion (PP). Until today, hardly any reliable data exist to analyze and compare the varying treatment approaches regarding efficacy and efficiency. In this randomized, multi-centric clinical trial, both treatment approaches will be compared. For this purpose, candidates for surgery will be randomized into one of the two treatment groups after informed consent has been obtained. Patients will be followed for 2 years by the participating centres to be able to evaluate the long-term effect of the surgical interventions.


Condition Intervention
Pneumothorax
Recurrent Pneumothorax
Procedure: wedge resection
Procedure: parietal pleurectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Pulmonary Wedge Resection Plus Parietal Pleurectomy (WRPP) Versus Parietal Pleurectomy (PP) for the Treatment of Recurrent Primary Pneumothorax

Resource links provided by NLM:


Further study details as provided by Wuerzburg University Hospital:

Primary Outcome Measures:
  • Recurrence rate of primary pneumothorax following VAT surgery [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Patients are followed to identify all incidents of recurrent lung collapse following VAT surgery. Suspected recurrences will be confirmed by chest X-ray.


Secondary Outcome Measures:
  • postoperative morbidity [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • postoperative pain [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • costs of treatment [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: November 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: wedge resection+parietal pleurectomy
Surgical treatment includes parietal pleurectomy and wedge resection of the tip of the lung.
Procedure: wedge resection
Complementary to parietal pleurectomy lung tissue is resected.
Procedure: parietal pleurectomy
The parietal pleura is resected for treating primary pneumothorax.
Active Comparator: parietal pleurectomy
Surgical therapy is limited to parietal pleurectomy.
Procedure: parietal pleurectomy
The parietal pleura is resected for treating primary pneumothorax.

Detailed Description:

The trial will be conducted at the major thoracic surgery units in Germany. Each centre can include patients on the basis of the presence of a PSP and the inclusion and exclusion criteria.

After informed consent has been obtained from the study participants, each has to fill out the standardized short-form health survey (SF-36) questionnaire and the visual analogue scale (VAS) to determine baseline parameters for the (current) state of health and pain level.Randomization into the two interventional groups is carried out before surgery.

Patients are operated according to good clinical practice either by pleurectomy alone (PP) or total parietal pleurectomy with apical wedge resection of the pulmonary apex (WRPP). Procedure related parameters (like operation time, applied suture materials including staplers) are documented.

The postoperative care is subject to each participating centre's standards. The postoperative course is evaluated (mortality, morbidity, duration of tube drainage, re-interventions or operations, length of stay, need for blood substitutions).

To evaluate the long term effect of the surgical intervention, all study participants are followed for 2 years.

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • recurrence of a primary pneumothorax
  • persistent primary pneumothorax
  • patient preference (in primary events)

Exclusion Criteria:

  • presence of a pulmonal fistula
  • underlying lung disease
  • previous thoracic surgery (except tube thoracostomy)
  • previous pleurodesis
  • conversion thoracotomy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855464

Contacts
Contact: Thorsten Walles, MD +49 (0)931 201 ext 33001 Walles_T@ukw.de
Contact: Jens Neudecker, MD + 49 (0)30 450 ext 522125 Jens.Neudecker@charite.de

Locations
Germany
Vivantes Thoraxzentrum Recruiting
Berlin, Germany, 12351
Contact: Stephan Eggeling, MD    +49 (0)30 130 14 ext 4251    thoraxchirurgie@vivantes.de   
Principal Investigator: Stephan Eggeling, MD         
DRK Kliniken Berlin Recruiting
Berlin, Germany, 13359
Contact: Paul Schneider, MD    +49(0)30 3035 ext 6405    p.schneider@drk-kliniken-berlin.de   
Principal Investigator: Paul Schneider, MD         
Charité Recruiting
Berlin, Germany, 10117
Contact: Jens Neudecker, MD    +49 (0)30 450 522 ext 011    Jens.Neudecker@charite.de   
Principal Investigator: Jens Neudecker, MD         
Evangelische Lungenklinik Berlin Recruiting
Berlin, Germany, 13125
Contact: Gunda Leschber, MD    +49 (0)30 94802 ext 102    Gunda.Leschber@elk-berlin.de   
Principal Investigator: Gunda Leschber, MD         
Universitätsklinikum Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Horia Sirbu, MD    +49 (0)9131 85 ext 32047    Horia.Sirbu@uk-erlangen.de   
Principal Investigator: Horia Sirbu, MD         
Sub-Investigator: Oliver Oster, MD         
Universitätsklinikum Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Sebastian Wiesemann, MD    +49 (0)761 270 ext 24010    sebastian.wiesemann@uniklinik-freiburg.de   
Principal Investigator: Sebastian Wiesemann, MD         
LungenClinic Grosshansdorf Recruiting
Großhansdorf, Germany, 22927
Contact: Christian Kugler, MD    +49 (0)4102 601 ext 2201    c.kugler@lungenclinic.de   
Principal Investigator: Christian Kugler, MD         
Sub-Investigator: Nina Städtler, MD         
Universitätsklinikum Hamburg-Eppendorf Not yet recruiting
Hamburg-Eppendorf, Germany, 20246
Contact: Michael Tachezy, MD    0407410 ext 50152    mtachezy@uke.uni-hamburg.de   
Principal Investigator: Jakob Izbicki, MD         
Thoraxklinik am Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69126
Contact: Michael Klopp, MD    +49 (0)6221 3962762 ext 1100    michael.klopp@urz.uni-heidelberg.de   
Principal Investigator: Michael Klopp, MD         
St. Bernward Krankenhaus Recruiting
Hildesheim, Germany, 31134
Contact: Andreas Simon, MD    0512190 ext 1278    dr.a.simon@bernward-khs.de   
Principal Investigator: Andreas Simon, MD         
Lungenklinik Köln Merheim Recruiting
Köln, Germany, 51109
Contact: Erich Stoelben, MD    +49 (0)221 8907 ext 8640    StoelbenE@kliniken-koeln.de   
Principal Investigator: Erich Stoelben, MD         
Sub-Investigator: Frank Bekkers, MD         
Klinik Löwenstein Recruiting
Löwenstein, Germany, 74245
Contact: Thomas Gräter, MD    +49 (0)7130 15 ext 4203    chirurgie@klinik-loewenstein.de   
Principal Investigator: Thomas Gräter, MD         
LMU München Not yet recruiting
München, Germany, 81377
Contact: Rudolf Hatz, MD    +49 (0)89 85 791 ext 4201    r.hatz@asklepios.com   
Contact: Hauke Winter, MD    +49 (0)89 7095 ext 0    hauke.Winter@med.uni-muenchen.de   
Principal Investigator: Rudolf Hatz, MD         
Sub-Investigator: Hauke Winter, MD         
Asklepios Fachklinik Recruiting
München-Gauting, Germany, 82131
Contact: Jan Fertmann, MD    08985791 ext 4931    j.fertmann@asklepios.com   
Principal Investigator: Rudolf Hatz, MD         
Thoraxzentrum Bezirk Unterfranken Recruiting
Münnerstadt, Germany, 97702
Contact: Boris Kardziev, MD    +49 (0)9733 62 ext 3700    b.kardziev@tzbu.de   
Principal Investigator: Boris Kardziev, MD         
Universitätsklinikum Regensburg Recruiting
Regensburg, Germany, 93053
Contact: Hans Hofmann, MD    +49 (0)941 944 ext 9801    hans-stefan.hofmann@klinik.uni-regensburg.de   
Principal Investigator: Hans-Stefan Hofmann, MD         
Krankenhaus Barmherzige Brüder Recruiting
Regensburg, Germany, 93049
Contact: Hans-Stefan Hofmann, MD    0941369 ext 2231    hans-stefan.hofmann@ukr.de   
Principal Investigator: Hans-Stefan Hofmann, MD         
Robert Bosch Krankenhaus Not yet recruiting
Stuttgart, Germany, 70376
Contact: Godehard Friedel, MD    +49 7156 203 ext 2240    friedel@klinik-schillerhoehe.de   
Contact: Stefanie Veit, MD    +49 7156 203 ext 2231    Stefanie.Veit@klinik-schillerhoehe.de   
Principal Investigator: Godehard Friedel, MD         
Sub-Investigator: Stefanie Veit, MD         
Sub-Investigator: Enole Boedeker, MD         
Universitätsklinik Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Volker Steger, MD    +49 (0)7071 298 ext 3365    Volker.Steger@med.uni-tuebingen.de   
Principal Investigator: Volker Steger, MD         
Universitätsklinikum Würzburg Recruiting
Wuerzburg, Germany, 97080
Contact: Thorsten Walles, MD FETCS    +49-931-201- ext 33016    Walles_T@ukw.de   
Contact: Stefanie Meyer, Monitor    +49-931-201 ext 33106      
Principal Investigator: Thorsten Walles, MD FETCS         
Sponsors and Collaborators
Wuerzburg University Hospital
German Research Foundation
German Federal Ministry of Education and Research
Investigators
Study Chair: Thorsten Walles, MD Wuerzburg University Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT01855464     History of Changes
Other Study ID Numbers: UKW-TCH-2013-001, German Research Foundation
Study First Received: May 6, 2013
Last Updated: August 6, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Wuerzburg University Hospital:
pneumothorax
primary pneumothorax
lung collapse

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014