Primary Spontaneous Pneumothorax Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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