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| ID | Type | Description | Link |
|---|---|---|---|
| German Research Foundation | Other Grant/Funding Number | DFG WA 1649/5-1 |
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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| wedge resection+parietal pleurectomy | Experimental | Surgical treatment includes parietal pleurectomy and wedge resection of the tip of the lung. |
|
| parietal pleurectomy | Active Comparator | Surgical therapy is limited to parietal pleurectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wedge resection | Procedure | Complementary to parietal pleurectomy lung tissue is resected. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thorsten Walles, MD | Magdeburg University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum rechts der Isar München | München | Bavaria | 81675 | Germany | ||
| Universitätsklinikum Magdeburg A. ö. R. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12728149 | Background | 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. | |
| 19966346 | Background | 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. |
| Label | URL |
|---|---|
| Click here for information on German Research Foundation Grant | View source |
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| parietal pleurectomy | Procedure | The parietal pleura is resected for treating primary pneumothorax. |
|
| 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 |
| Magdeburg |
| Saxony-Anhalt |
| 39120 |
| Germany |
| Charité | Berlin | 10117 | Germany |
| Vivantes Thoraxzentrum | Berlin | 12351 | Germany |
| Evangelische Lungenklinik Berlin | Berlin | 13125 | Germany |
| DRK Kliniken Berlin | Berlin | 13359 | Germany |
| Lungenklinik Köln Merheim | Cologne | 51109 | Germany |
| Universitätsklinikum Carl Gustav Carus Dresden | Dresden | 01307 | Germany |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| LungenClinic Grosshansdorf | Großhansdorf | 22927 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg-Eppendorf | 20246 | Germany |
| Thoraxklinik am Universitätsklinikum Heidelberg | Heidelberg | 69126 | Germany |
| Asklepios Klinik Langen | Langen | 63225 | Germany |
| LMU München | München | 81377 | Germany |
| Asklepios Fachklinik | München-Gauting | 82131 | Germany |
| Thoraxzentrum Bezirk Unterfranken | Münnerstadt | 97702 | Germany |
| Krankenhaus Barmherzige Brüder | Regensburg | 93049 | Germany |
| Universitätsklinikum Regensburg | Regensburg | 93053 | Germany |
| Robert Bosch Krankenhaus | Stuttgart | 70376 | Germany |
| Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH | Treuenbrietzen | 14929 | Germany |
| Universitätsklinik Tübingen | Tübingen | 72076 | Germany |
| Universitätsklinikum Würzburg | Würzburg | 97080 | Germany |
| 14752638 | Background | 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. |
| 26620271 | Derived | 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. |
| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
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