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

Pulmonary Wedge Resection Plus Parietal Pleurectomy (WRPP) Versus Parietal Pleurectomy (PP) for the Treatment of Recurrent Primary Pneumothorax

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pneumothorax; Recurrent Pneumothorax
• Intervention / Treatment: Procedure: wedge resection; Procedure: parietal pleurectomy

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 Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13125
    • Evangelische Lungenklinik Berlin
  • Berlin, Germany, 10117
    • Charité
  • Berlin, Germany, 12351
    • Vivantes Thoraxzentrum
  • Berlin, Germany, 13359
    • DRK Kliniken Berlin
  • Dresden, Germany, 01307
    • Universitätsklinikum Carl Gustav Carus Dresden
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen
  • Freiburg, Germany, 79106
    • Universitätsklinikum Freiburg
  • Großhansdorf, Germany, 22927
    • LungenClinic Grosshansdorf
  • Hamburg-Eppendorf, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf
  • Heidelberg, Germany, 69126
    • Thoraxklinik am Universitatsklinikum Heidelberg
  • Köln, Germany, 51109
    • Lungenklinik Köln Merheim
  • Langen, Germany, 63225
    • Asklepios Klinik Langen
  • München, Germany, 81377
    • LMU München
  • München-Gauting, Germany, 82131
    • Asklepios Fachklinik
  • Münnerstadt, Germany, 97702
    • Thoraxzentrum Bezirk Unterfranken
  • Regensburg, Germany, 93053
    • Universitätsklinikum Regensburg
  • Regensburg, Germany, 93049
    • Krankenhaus Barmherzige Brüder
  • Stuttgart, Germany, 70376
    • Robert Bosch Krankenhaus
  • Treuenbrietzen, Germany, 14929
    • Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH
  • Tübingen, Germany, 72076
    • Universitätsklinik Tübingen
  • Wuerzburg, Germany, 97080
    • Universitatsklinikum Wurzburg
  • Bavaria
    • München, Bavaria, Germany, 81675
      • Klinikum rechts der Isar München
  • Saxony-Anhalt
    • Magdeburg, Saxony-Anhalt, Germany, 39120
      • Universitätsklinikum Magdeburg A. ö. R.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate of primary pneumothorax following VAT surgery	Patients are followed to identify all incidents of recurrent lung collapse following VAT surgery. Suspected recurrences will be confirmed by chest X-ray.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative morbidity	postoperative complications	30 days
postoperative pain	rest and stress with a pain scale ranging from 1 to 10 (measured with the Visual Analogue Scale - VAS)	7 days
function quality of life	measured with SF-36 Health Survey (The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 Lower scores = more disability, higher scores = less disability Sections:Vitality;Physical functioning;Bodily pain;General health perceptions;Physical role functioning;Emotional role functioning;Social role functioning;Mental Health)	2 years
costs of treatment	documentation of postoperative Hospitalization, the number of trocars	up to 30 days

Collaborators and Investigators

• Sponsor: Otto-von-Guericke University Magdeburg
• Collaborators: German Research Foundation
• Investigators: Study Chair: Thorsten Walles, MD, Magdeburg University Hospital

Publications and helpful links

General 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(Suppl 2):ii39-52. doi: 10.1136/thorax.58.suppl_2.ii39. No abstract available.
• 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. doi: 10.1007/s00464-003-9067-z. Epub 2004 Feb 2.
• 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.

Helpful Links

• Click here for information on German Research Foundation Grant
• Official Trial Website

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: May 6, 2013
• First Submitted That Met QC Criteria: May 13, 2013
• First Posted (Estimated): May 16, 2013

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: pneumothorax; primary pneumothorax; lung collapse
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Pleural Diseases; Pneumothorax; Recurrence
• Other Study ID Numbers: UKW-TCH-2013-001; German Research Foundation (Other Grant/Funding Number: DFG WA 1649/5-1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO