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
German Research Foundation
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Wuerzburg University Hospital Identifier:
First received: May 6, 2013
Last updated: August 6, 2014
Last verified: August 2014
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
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.


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

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 identifier: NCT01855464

Contact: Thorsten Walles, MD +49 (0)931 201 ext 33001
Contact: Jens Neudecker, MD + 49 (0)30 450 ext 522125

Charité Recruiting
Berlin, Germany, 10117
Contact: Jens Neudecker, MD    +49 (0)30 450 522 ext 011   
Principal Investigator: Jens Neudecker, MD         
DRK Kliniken Berlin Recruiting
Berlin, Germany, 13359
Contact: Paul Schneider, MD    +49(0)30 3035 ext 6405   
Principal Investigator: Paul Schneider, MD         
Evangelische Lungenklinik Berlin Recruiting
Berlin, Germany, 13125
Contact: Gunda Leschber, MD    +49 (0)30 94802 ext 102   
Principal Investigator: Gunda Leschber, MD         
Vivantes Thoraxzentrum Recruiting
Berlin, Germany, 12351
Contact: Stephan Eggeling, MD    +49 (0)30 130 14 ext 4251   
Principal Investigator: Stephan Eggeling, MD         
Universitätsklinikum Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Horia Sirbu, MD    +49 (0)9131 85 ext 32047   
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   
Principal Investigator: Sebastian Wiesemann, MD         
LungenClinic Grosshansdorf Recruiting
Großhansdorf, Germany, 22927
Contact: Christian Kugler, MD    +49 (0)4102 601 ext 2201   
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   
Principal Investigator: Jakob Izbicki, MD         
Thoraxklinik am Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69126
Contact: Michael Klopp, MD    +49 (0)6221 3962762 ext 1100   
Principal Investigator: Michael Klopp, MD         
St. Bernward Krankenhaus Recruiting
Hildesheim, Germany, 31134
Contact: Andreas Simon, MD    0512190 ext 1278   
Principal Investigator: Andreas Simon, MD         
Lungenklinik Köln Merheim Recruiting
Köln, Germany, 51109
Contact: Erich Stoelben, MD    +49 (0)221 8907 ext 8640   
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   
Principal Investigator: Thomas Gräter, MD         
LMU München Not yet recruiting
München, Germany, 81377
Contact: Rudolf Hatz, MD    +49 (0)89 85 791 ext 4201   
Contact: Hauke Winter, MD    +49 (0)89 7095 ext 0   
Principal Investigator: Rudolf Hatz, MD         
Sub-Investigator: Hauke Winter, MD         
Asklepios Fachklinik Recruiting
München-Gauting, Germany, 82131
Contact: Jan Fertmann, MD    08985791 ext 4931   
Principal Investigator: Rudolf Hatz, MD         
Thoraxzentrum Bezirk Unterfranken Recruiting
Münnerstadt, Germany, 97702
Contact: Boris Kardziev, MD    +49 (0)9733 62 ext 3700   
Principal Investigator: Boris Kardziev, MD         
Krankenhaus Barmherzige Brüder Recruiting
Regensburg, Germany, 93049
Contact: Hans-Stefan Hofmann, MD    0941369 ext 2231   
Principal Investigator: Hans-Stefan Hofmann, MD         
Universitätsklinikum Regensburg Recruiting
Regensburg, Germany, 93053
Contact: Hans Hofmann, MD    +49 (0)941 944 ext 9801   
Principal Investigator: Hans-Stefan Hofmann, MD         
Robert Bosch Krankenhaus Not yet recruiting
Stuttgart, Germany, 70376
Contact: Godehard Friedel, MD    +49 7156 203 ext 2240   
Contact: Stefanie Veit, MD    +49 7156 203 ext 2231   
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   
Principal Investigator: Volker Steger, MD         
Universitätsklinikum Würzburg Recruiting
Wuerzburg, Germany, 97080
Contact: Thorsten Walles, MD FETCS    +49-931-201- ext 33016   
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
Study Chair: Thorsten Walles, MD Wuerzburg University Hospital
  More Information

Additional Information:
Responsible Party: Wuerzburg University Hospital 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:
primary pneumothorax
lung collapse

Additional relevant MeSH terms:
Pleural Diseases
Respiratory Tract Diseases processed this record on November 30, 2015