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| Name | Class |
|---|---|
| Danish Medical Association | OTHER |
| Danmarks Lungeforening | OTHER |
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Knowledge about incidence, risk factors and genetic predispositions of primary spontaneous pneumothorax in young adults is very limited, and treatment has also been controversial.The Aim of this study is to optimize the treatment, estimate the actual incidence, and identify possible risk factors including genetic predispositions.
Participants are followed for ten years. The primary endpoint is ipsilateral recurrence of pneumothorax. Secondary endpoints are length of hospitalization, duration of chest tube drainage and miscellaneous complications.
Simultaneously, a research biobank containing blood samples and pulmonary tissue is created for future studies of biomarkers and possible genetic causes.
Finally, the investigators are conducting a national epidemiological study, where the incidence in the Danish population is investigated.
*Perspective This study contributes new knowledge on incidence, genetics and best treatment of primary spontaneous pneumothorax in young adults which will have an impact on the future strategy of both understanding and treatment of this disease on a global level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRCT with bullae, treatment conservative | Experimental | Patients undergo High-resolution CT scan, and significant bullae are identified (i.e. > 1 cm). Afterwards randomised to conservative treatment with conventional chest-tube drainage. |
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| HRCT no bullae, treatment conservative | Experimental | Patients undergo High-resolution CT scan, and no significant bullae are identified (i.e. > 1 cm). Afterwards randomised to conservative treatment with conventional chest-tube drainage. |
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| HRCT with bullae, treatment VATS. | Experimental | Patients undergo High-resolution CT scan, and significant bullae are identified (i.e. > 1 cm). Afterwards randomised to active treatment with VATS bullectomy and mechanical pleurodesis. |
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| HRCT no bullae, treatment VATS. | Experimental | Patients undergo High-resolution CT scan, and no significant bullae are identified (i.e. > 1 cm). Afterwards randomised to active treatment with VATS bullectomy and mechanical pleurodesis. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VATS bullectomy and mechanical pleuradesis. | Procedure | Thoracoscopic bullectomy is performed on all visible bullae, alternatively is no visible bullae, the apex is resected. Then mechanical pleuradesis is performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to ipsilateral recurrence | All participants are followed 10 years from the initial discharge via Questionnaires | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 10 years | |
| Length of hospital stay | Length of initial hospital stay | up to 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Winnie Hedevang Olesen, ph.d.student | Contact | 0045-22947131 | winnie.olesen@rsyd.dk | |
| Peter Bjørn Licht, Professor | Contact | 0045-65413385 | peter.licht@ouh.regionsyddanmark.dk |
| Name | Affiliation | Role |
|---|---|---|
| Winnie Hedevang Olesen, ph.d.student | Research Unit at the Cardiothoracic Department at the University Hospital of Odense. | Study Director |
| Peter Bjørn Licht, Professor MD | Research Unit at the Cardiothoracic Department at the University Hospital of Odense |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Unit at the Cardiothoracic Department at the University Hospital of Skejby | Recruiting | Aarhus | Central Jutland | 8600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29509892 | Derived | Olesen WH, Katballe N, Sindby JE, Titlestad IL, Andersen PE, Lindahl-Jacobsen R, Licht PB. Surgical treatment versus conventional chest tube drainage in primary spontaneous pneumothorax: a randomized controlled trial. Eur J Cardiothorac Surg. 2018 Jul 1;54(1):113-121. doi: 10.1093/ejcts/ezy003. |
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| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| D010995 | Pleural Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007268 | Injections, Epidural |
| ID | Term |
|---|---|
| D007278 | Injections, Spinal |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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| Chest tube insertion | Procedure | Conventional chest tube insertion. |
|
| Epidural | Drug | All surgical participants received an epidural prior to the procedure.The epidural was removed simultaneous with the the chest tube. |
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| High-resolution Computer Tomography | Radiation | All participants included in this study had a HRCT performed. |
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| Pain according to NRS scale reported at discharge, at 4 weeks, 1 year, 5 years and 10 years. | up to 10 years |
| Research Unit at the cardiothoracic departement at the University Hospital of Odense | Recruiting | Odense | Fyn | 5690 | Denmark |
|
| Research Unit at the Cardiothoracic Department af Ålborg Hospital | Recruiting | Aalborg | North Denmark | 9100 | Denmark |
|
| D013812 |
| Therapeutics |