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

NCT ID: NCT01855464

Last Updated: 2023-11-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2024-08-31

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.

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.

Conditions

Pneumothorax; Recurrent Pneumothorax

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

wedge resection+parietal pleurectomy

Surgical treatment includes parietal pleurectomy and wedge resection of the tip of the lung.

Group Type: EXPERIMENTAL

wedge resection

Intervention Type: PROCEDURE

Complementary to parietal pleurectomy lung tissue is resected.

parietal pleurectomy

Intervention Type: PROCEDURE

The parietal pleura is resected for treating primary pneumothorax.

parietal pleurectomy

Surgical therapy is limited to parietal pleurectomy.

Group Type: ACTIVE_COMPARATOR

parietal pleurectomy

Intervention Type: PROCEDURE

The parietal pleura is resected for treating primary pneumothorax.

Interventions

wedge resection

Complementary to parietal pleurectomy lung tissue is resected.

Intervention Type: PROCEDURE

parietal pleurectomy

The parietal pleura is resected for treating primary pneumothorax.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Research Foundation

OTHER

Sponsor Role: collaborator

Otto-von-Guericke University Magdeburg

OTHER

Sponsor Role: lead

Responsible Party

Torsten Walles

Univ. Prof. Dr. med. Thorsten Walles, Director, thoracic surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thorsten Walles, MD

Role: STUDY_CHAIR

Magdeburg University Hospital

Locations

Klinikum rechts der Isar München

München, Bavaria, Germany

Universitätsklinikum Magdeburg A. ö. R.

Magdeburg, Saxony-Anhalt, Germany

Charité

Berlin, , Germany

Vivantes Thoraxzentrum

Berlin, , Germany

Evangelische Lungenklinik Berlin

Berlin, , Germany

DRK Kliniken Berlin

Berlin, , Germany

Lungenklinik Köln Merheim

Cologne, , Germany

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, , Germany

Universitätsklinikum Erlangen

Erlangen, , Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

LungenClinic Grosshansdorf

Großhansdorf, , Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg-Eppendorf, , Germany

Thoraxklinik am Universitätsklinikum Heidelberg

Heidelberg, , Germany

Asklepios Klinik Langen

Langen, , Germany

LMU München

München, , Germany

Asklepios Fachklinik

München-Gauting, , Germany

Thoraxzentrum Bezirk Unterfranken

Münnerstadt, , Germany

Krankenhaus Barmherzige Brüder

Regensburg, , Germany

Universitätsklinikum Regensburg

Regensburg, , Germany

Robert Bosch Krankenhaus

Stuttgart, , Germany

Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH

Treuenbrietzen, , Germany

Universitätsklinik Tübingen

Tübingen, , Germany

Universitätsklinikum Würzburg

Würzburg, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 12728149 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19966346 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14752638 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26620271 (View on PubMed)

Related Links

http://gepris.dfg.de/gepris/OCTOPUS/;jsessionid=E6A2D8650C043C03A91FE2EC2CE5C091?context=projekt&id=209750507&module=gepris&task=showDetail

Click here for information on German Research Foundation Grant

http://www.wopp-studie.de

Official Trial Website

Other Identifiers

German Research Foundation

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UKW-TCH-2013-001

Identifier Type: -

Identifier Source: org_study_id