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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Click here for information on German Research Foundation Grant 

Official Trial Website 

Publications:

Henry M, Arnold T, Harvey J; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of spontaneous pneumothorax. Thorax. 2003 May;58 Suppl 2:ii39-52.

Chan JW, Ko FW, Ng CK, Yeung AW, Yee WK, So LK, Lam B, Wong MM, Choo KL, Ho AS, Tse PY, Fung SL, Lo CK, Yu WC. Management of patients admitted with pneumothorax: a multi-centre study of the practice and outcomes in Hong Kong. Hong Kong Med J. 2009 Dec;15(6):427-33.

Gossot D, Galetta D, Stern JB, Debrosse D, Caliandro R, Girard P, Grunenwald D. Results of thoracoscopic pleural abrasion for primary spontaneous pneumothorax. Surg Endosc. 2004 Mar;18(3):466-71. Epub 2004 Feb 2. Review.

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

Neudecker J, Malzahn U, Heuschmann P, Behrens U, Walles T. 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. Trials. 2015 Nov 30;16:540. doi: 10.1186/s13063-015-1060-z.

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
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