Study Designed to Optimize the Treatment of Primary Pneumothorax
NCT ID: NCT02866305
Last Updated: 2016-08-16
Study Results
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Basic Information
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UNKNOWN
EARLY_PHASE1
300 participants
INTERVENTIONAL
2009-03-31
2024-12-31
Brief Summary
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Detailed Description
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* Method From July 2009 the investigators conducted a nationwide study , where 300 consecutive patients admitted to a Danish hospital with primary spontaneous pneumothorax undergo a high resolution CT of the thorax. Based upon the CT the patients are randomised to conventional conservative treatment (chest tube drainage) or primary VATS with bleb resection and mechanical pleurodesis.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HRCT with bullae, treatment conservative
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.
Chest tube insertion
Conventional chest tube insertion.
High-resolution Computer Tomography
All participants included in this study had a HRCT performed.
HRCT no bullae, treatment conservative
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.
Chest tube insertion
Conventional chest tube insertion.
High-resolution Computer Tomography
All participants included in this study had a HRCT performed.
HRCT with bullae, treatment VATS.
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.
VATS bullectomy and mechanical pleuradesis.
Thoracoscopic bullectomy is performed on all visible bullae, alternatively is no visible bullae, the apex is resected. Then mechanical pleuradesis is performed.
Chest tube insertion
Conventional chest tube insertion.
Epidural
All surgical participants received an epidural prior to the procedure.The epidural was removed simultaneous with the the chest tube.
High-resolution Computer Tomography
All participants included in this study had a HRCT performed.
HRCT no bullae, treatment VATS.
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.
VATS bullectomy and mechanical pleuradesis.
Thoracoscopic bullectomy is performed on all visible bullae, alternatively is no visible bullae, the apex is resected. Then mechanical pleuradesis is performed.
Chest tube insertion
Conventional chest tube insertion.
Epidural
All surgical participants received an epidural prior to the procedure.The epidural was removed simultaneous with the the chest tube.
High-resolution Computer Tomography
All participants included in this study had a HRCT performed.
Interventions
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VATS bullectomy and mechanical pleuradesis.
Thoracoscopic bullectomy is performed on all visible bullae, alternatively is no visible bullae, the apex is resected. Then mechanical pleuradesis is performed.
Chest tube insertion
Conventional chest tube insertion.
Epidural
All surgical participants received an epidural prior to the procedure.The epidural was removed simultaneous with the the chest tube.
High-resolution Computer Tomography
All participants included in this study had a HRCT performed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 40.
* No known preexisting pulmonary disease.
* Patient must accept randomization.
* Able to read and understand information regarding the study.
* The condition must require treatment with a chest-tube.
Exclusion Criteria
* Previously pulmonary og cardiac surgery.
* Pregnant or breastfeeding.
* Patients who do not tolerate anesthetics.
18 Years
40 Years
ALL
No
Sponsors
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Danish Medical Association
OTHER
Danmarks Lungeforening
OTHER
Odense University Hospital
OTHER
Responsible Party
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Winnie Hedevang Olesen
MD and Principal investigator
Principal Investigators
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Winnie Hedevang Olesen, ph.d.student
Role: STUDY_DIRECTOR
Research Unit at the Cardiothoracic Department at the University Hospital of Odense.
Peter Bjørn Licht, Professor MD
Role: PRINCIPAL_INVESTIGATOR
Research Unit at the Cardiothoracic Department at the University Hospital of Odense
Locations
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Research Unit at the Cardiothoracic Department at the University Hospital of Skejby
Aarhus, Central Jutland, Denmark
Research Unit at the cardiothoracic departement at the University Hospital of Odense
Odense, Fyn, Denmark
Research Unit at the Cardiothoracic Department af Ålborg Hospital
Aalborg, North Denmark, Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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TOPP2009
Identifier Type: -
Identifier Source: org_study_id
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