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Thoracoscopic Treatment of Primary Pneumothorax - A National Randomised Controlled Trial
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.
* Background Knowledge about incidence, risk factors and genetic predispositions of primary spontaneous pneumothorax in young adults is very limited, and treatment has also been controversial. Typically, the first incidence is treated conservatively with simple chest tube drainage and only if the disease reoccurs is surgery considered. However, conventional treatment may be associated with increased morbidity, prolonged hospitalization and many young adults are concerned about the high recurrence of this disease. The latter has been reported in as many as 25-35% of patients. Because spontaneous pneumothorax in young adults usually is associated with apical blebs, the investigators hypothesized that primary surgery (Video-Assisted Thoracoscopic Surgery = VATS) with resection of such blebs at the time of the first episode of pneumothorax might be an effective first line treatment associated with lower morbidity and shorter hospital stays, and a definite decline in recurrence rate. * 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.
Age
18 - 40 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
March 1, 2009
Primary Completion Date
December 1, 2017
Completion Date
December 1, 2024
Last Updated
August 16, 2016
300
ESTIMATED participants
VATS bullectomy and mechanical pleuradesis.
PROCEDURE
Chest tube insertion
PROCEDURE
Epidural
DRUG
High-resolution Computer Tomography
RADIATION
Lead Sponsor
Odense University Hospital
Collaborators
NCT06411431
NCT06413966
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02414269