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

NCT01855464 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2023-11-02

No results posted yet for this study

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.

Conditions

  • Pneumothorax
  • Recurrent Pneumothorax

Interventions

PROCEDURE

wedge resection

Complementary to parietal pleurectomy lung tissue is resected.

PROCEDURE

parietal pleurectomy

The parietal pleura is resected for treating primary pneumothorax.

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER

  • Otto-von-Guericke University Magdeburg

    lead OTHER

Principal Investigators

  • Thorsten Walles, MD · Magdeburg University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2024-07-31
Completion
2024-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01855464 on ClinicalTrials.gov