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

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ClinicalTrials.gov Identifier: NCT01855464
Recruitment Status : Recruiting
First Posted : May 16, 2013
Last Update Posted : May 3, 2017
Sponsor:
Collaborators:
German Research Foundation
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Wuerzburg University Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Pneumothorax Recurrent Pneumothorax Procedure: wedge resection Procedure: parietal pleurectomy Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pulmonary Wedge Resection Plus Parietal Pleurectomy (WRPP) Versus Parietal Pleurectomy (PP) for the Treatment of Recurrent Primary Pneumothorax
Study Start Date : November 2013
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence rate of primary pneumothorax following VAT surgery [ Time Frame: 2 years ]
    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 :
  1. postoperative morbidity [ Time Frame: 30 days ]
  2. postoperative pain [ Time Frame: 7 days ]
  3. quality of life [ Time Frame: 2 years ]
  4. costs of treatment [ Time Frame: up to 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855464


Contacts
Contact: Thorsten Walles, MD +49 (0)391 67 ext 14102 thorsten.walles@med.ovgu.de
Contact: Jens Neudecker, MD + 49 (0)30 450 ext 522125 Jens.Neudecker@charite.de

Locations
Germany
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         
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         
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         
DRK Kliniken Berlin Recruiting
Berlin, Germany, 13359
Contact: Karina Oymann, MD    +49(0)30 3035 ext 6405    k.oymann@drk-kliniken-berlin.de   
Principal Investigator: Karina Oymann, MD         
Universitätsklinikum Carl Gustav Carus Dresden Recruiting
Dresden, Germany, 01307
Contact: Thilo Welsch, MD    0351 458 ext 18283    thilo.welsch@uniklinikum-dresden.de   
Principal Investigator: Thilo Welsch, 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         
St. Elisabethen-Krankenhaus Katharina Recruiting
Frankfurt am Main, Germany, 60487
Contact: Peter Kleine, MD    069 7939 ext 2645    info@prof-kleine.de   
Principal Investigator: Peter Kleine, MD         
Universitätsklinik Frankfurt Recruiting
Frankfurt am Main, Germany, 60596
Contact: Peter Kleine, MD    069 6301 ext 4976    Peter.Kleine@kgu.de   
Principal Investigator: Peter Kleine, 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 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: Christiane Grünewald, MD    +49 (0)6221 396 ext 0    Christiane.Gruenewald@med.uni-heidelberg.de   
Principal Investigator: Christiane Grünewald, 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         
Asklepios Klinik Langen Recruiting
Langen, Germany, 63225
Contact: Ernst Hanisch, MD    06103 912 ext 1309    e.hanisch@asklepios.com   
Contact: Beate Kuhn    06103 912 ext 1309    b.kuhn@asklepios.com   
Principal Investigator: Ernst Hanisch, MD         
Asklepios Fachklinik Recruiting
München-Gauting, Germany, 82131
Contact: Jan Fertmann, MD    08985791 ext 4931    j.fertmann@asklepios.com   
Principal Investigator: Rudolf Hatz, MD         
LMU München Recruiting
München, Germany, 81377
Contact: Rudolf Hatz, MD    +49 (0)89 4400 ext 76511    r.hatz@med.uni-muenchen.de   
Contact: Jan Fertmann, MD    +49 (0)89 4400 ext 76511    Jan.Fertmann@med.uni-muenchen.de   
Principal Investigator: Rudolf Hatz, MD         
Sub-Investigator: Jan Fertmann, 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         
Krankenhaus Barmherzige Brüder Recruiting
Regensburg, Germany, 93049
Contact: Hans-Stefan Hofmann, MD    0941 369 ext 2231    hans-stefan.hofmann@ukr.de   
Contact: Rudolf Schemm, MD    0941 369 ext 94261    rudolf.schemm@barmherzige-regensburg.de   
Principal Investigator: Hans-Stefan Hofmann, 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         
Robert Bosch Krankenhaus Recruiting
Stuttgart, Germany, 70376
Contact: Godehard Friedel, MD    +49 7156 203 ext 2240    friedel@klinik-schillerhoehe.de   
Contact: Andrea Hofbauer    +49 7156 203 ext 7257    andrea.hofbauer@klinik-schillerhoehe.de   
Principal Investigator: Godehard Friedel, 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 Active, not recruiting
Wuerzburg, Germany, 97080
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
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Additional Information:
Click here for information on German Research Foundation Grant  This link exits the ClinicalTrials.gov site
Official Trial Website  This link exits the ClinicalTrials.gov site

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT01855464     History of Changes
Other Study ID Numbers: UKW-TCH-2013-001
German Research Foundation ( Other Grant/Funding Number: DFG WA 1649/5-1 )
First Posted: May 16, 2013    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases