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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pneumothorax, Recurrent Pneumothorax

Intervention / Treatment
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* Procedure: wedge resection
* Procedure: parietal pleurectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: wedge resection+parietal pleurectomy<br>Surgical treatment includes parietal pleurectomy and wedge resection of the tip of the lung. | Procedure: wedge resection<br>* Complementary to parietal pleurectomy lung tissue is resected.<br>Procedure: parietal pleurectomy<br>* The parietal pleura is resected for treating primary pneumothorax.<br>|
| Active Comparator: parietal pleurectomy<br>Surgical therapy is limited to parietal pleurectomy. | Procedure: parietal pleurectomy<br>* The parietal pleura is resected for treating primary pneumothorax.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary pneumothorax, pneumothorax, lung collapse