NCT01855464

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

23 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

November 2, 2023

Status Verified

November 1, 2023

Enrollment Period

10.7 years

First QC Date

May 6, 2013

Last Update Submit

November 1, 2023

Conditions

PneumothoraxRecurrent Pneumothorax

Keywords

pneumothoraxprimary pneumothoraxlung collapse

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • postoperative morbidity

    30 days

  • postoperative pain

    7 days

  • function quality of life

    2 years

  • costs of treatment

    up to 30 days

Study Arms (2)

wedge resection+parietal pleurectomy

EXPERIMENTAL

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

Procedure: wedge resectionProcedure: parietal pleurectomy

parietal pleurectomy

ACTIVE COMPARATOR

Surgical therapy is limited to parietal pleurectomy.

Procedure: parietal pleurectomy

Interventions

wedge resectionPROCEDURE

Complementary to parietal pleurectomy lung tissue is resected.

wedge resection+parietal pleurectomy
parietal pleurectomyPROCEDURE

The parietal pleura is resected for treating primary pneumothorax.

parietal pleurectomywedge resection+parietal pleurectomy

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • recurrence of a primary pneumothorax
  • persistent primary pneumothorax
  • patient preference (in primary events)

You may not qualify if:

  • presence of a pulmonal fistula
  • underlying lung disease
  • previous thoracic surgery (except tube thoracostomy)
  • previous pleurodesis
  • conversion thoracotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Klinikum rechts der Isar München

München, Bavaria, 81675, Germany

Location

Universitätsklinikum Magdeburg A. ö. R.

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

Charité

Berlin, 10117, Germany

Location

Vivantes Thoraxzentrum

Berlin, 12351, Germany

Location

Evangelische Lungenklinik Berlin

Berlin, 13125, Germany

Location

DRK Kliniken Berlin

Berlin, 13359, Germany

Location

Lungenklinik Köln Merheim

Cologne, 51109, Germany

Location

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

LungenClinic Grosshansdorf

Großhansdorf, 22927, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg-Eppendorf, 20246, Germany

Location

Thoraxklinik am Universitätsklinikum Heidelberg

Heidelberg, 69126, Germany

Location

Asklepios Klinik Langen

Langen, 63225, Germany

Location

LMU München

München, 81377, Germany

Location

Asklepios Fachklinik

München-Gauting, 82131, Germany

Location

Thoraxzentrum Bezirk Unterfranken

Münnerstadt, 97702, Germany

Location

Krankenhaus Barmherzige Brüder

Regensburg, 93049, Germany

Location

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

Robert Bosch Krankenhaus

Stuttgart, 70376, Germany

Location

Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH

Treuenbrietzen, 14929, Germany

Location

Universitätsklinik Tübingen

Tübingen, 72076, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Related Publications (4)

  • 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.

    PMID: 12728149BACKGROUND

  • 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.

    PMID: 19966346BACKGROUND

  • 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.

    PMID: 14752638BACKGROUND

  • 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.

    PMID: 26620271DERIVED

Related Links

MeSH Terms

Conditions

PneumothoraxPulmonary Atelectasis

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract DiseasesLung Diseases

Study Officials

  • Thorsten Walles, MD

    Magdeburg University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ. Prof. Dr. med. Thorsten Walles, Director, thoracic surgery

Study Record Dates

First Submitted

May 6, 2013

First Posted

May 16, 2013

Study Start

November 1, 2013

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

November 2, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(23)