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
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Condition or disease | Intervention/treatment | Phase |
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Pneumothorax Recurrent Pneumothorax | Procedure: wedge resection Procedure: parietal pleurectomy | Not Applicable |
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 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 |

Arm | Intervention/treatment |
---|---|
Experimental: wedge resection+parietal pleurectomy
Surgical treatment includes parietal pleurectomy and wedge resection of the tip of the lung.
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Procedure: wedge resection
Complementary to parietal pleurectomy lung tissue is resected.
Procedure: parietal pleurectomy
The parietal pleura is resected for treating primary pneumothorax.
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Active Comparator: parietal pleurectomy
Surgical therapy is limited to parietal pleurectomy.
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Procedure: parietal pleurectomy
The parietal pleura is resected for treating primary pneumothorax.
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- 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.
- postoperative morbidity [ Time Frame: 30 days ]
- postoperative pain [ Time Frame: 7 days ]
- quality of life [ Time Frame: 2 years ]
- costs of treatment [ Time Frame: up to 30 days ]

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Ages Eligible for Study: | 15 Years to 40 Years (Child, Adult) |
Sexes Eligible for Study: | All |
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

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
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 |
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 |
Study Chair: | Thorsten Walles, MD | Wuerzburg University Hospital |
Additional Information:
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 |