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PneumothoraxWOPPNCT01855464

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

A study testing wedge resection and parietal pleurectomy in people with Pneumothorax and Recurrent Pneumothorax, run by Otto-von-Guericke University Magdeburg at 23 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 40 years
Conditions the study is for
Pneumothorax, Recurrent Pneumothorax
What is being tested?
wedge resection and parietal pleurectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
23 sitesGermany
Study dates
Nov 2013to Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Germany23 sites

  • Charité

    Berlin, 10117

  • Vivantes Thoraxzentrum

    Berlin, 12351

  • Evangelische Lungenklinik Berlin

    Berlin, 13125

  • DRK Kliniken Berlin

    Berlin, 13359

  • Lungenklinik Köln Merheim

    Cologne, 51109

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • LungenClinic Grosshansdorf

    Großhansdorf, 22927

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg-Eppendorf, 20246

  • Thoraxklinik am Universitätsklinikum Heidelberg

    Heidelberg, 69126

  • Asklepios Klinik Langen

    Langen, 63225

  • Universitätsklinikum Magdeburg A. ö. R.

    Magdeburg, Saxony-Anhalt, 39120

  • Klinikum rechts der Isar München

    München, Bavaria, 81675

  • LMU München

    München, 81377

  • Asklepios Fachklinik

    München-Gauting, 82131

  • Thoraxzentrum Bezirk Unterfranken

    Münnerstadt, 97702

  • Krankenhaus Barmherzige Brüder

    Regensburg, 93049

  • Universitätsklinikum Regensburg

    Regensburg, 93053

  • Robert Bosch Krankenhaus

    Stuttgart, 70376

  • Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH

    Treuenbrietzen, 14929

  • Universitätsklinik Tübingen

    Tübingen, 72076

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
wedge resection, parietal pleurectomy
Keywords
pneumothorax, primary pneumothorax, lung collapse
Medical subject headings
Pneumothorax, Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • wedge resectionProcedure or surgery

    Complementary to parietal pleurectomy lung tissue is resected.

  • parietal pleurectomyProcedure or surgery

    The parietal pleura is resected for treating primary pneumothorax.

Study groups in NCT01855464
Study groupRoleWhat they receive
wedge resection+parietal pleurectomyExperimentalSurgical treatment includes parietal pleurectomy and wedge resection of the tip of the lung.
Receives: Procedure: wedge resection; Procedure: parietal pleurectomy
parietal pleurectomyActive comparatorSurgical therapy is limited to parietal pleurectomy.
Receives: Procedure: parietal pleurectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (4)

  1. postoperative morbidity

    postoperative complications

    Measured: 30 days

  2. postoperative pain

    rest and stress with a pain scale ranging from 1 to 10 (measured with the Visual Analogue Scale - VAS)

    Measured: 7 days

  3. 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)

    Measured: 2 years

  4. costs of treatment

    documentation of postoperative Hospitalization, the number of trocars

    Measured: up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionJul 2024 (estimated)
  4. Study completionAug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01855464
Sponsor's protocol ID
UKW-TCH-2013-001
Other IDs
German Research Foundation
Acronym
WOPP
Status last verified
Nov 2023
First submitted
6 May 2013
Last updated
2 Nov 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

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.

    PubMed 12728149

  • 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.

    PubMed 19966346

  • 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.

    PubMed 14752638

  • 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.

    PubMed 26620271

Questions about this trial

What is this clinical trial studying?

A study testing wedge resection and parietal pleurectomy in people with Pneumothorax and Recurrent Pneumothorax, run by Otto-von-Guericke University Magdeburg at 23 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence rate of primary pneumothorax following VAT surgery (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01855464, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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