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Clinical Trials/NL-OMON56146
NL-OMON56146
Recruiting
Not Applicable

Optimal postoperative chest tube and pain management in patients surgically treated for primary spontaneous pneumothorax; a randomized controlled trial. - Pneumotrial

Maxima Medisch Centrum0 sites340 target enrollmentTBD
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ConditionsCollapsed lungPneumothorax1001336910038737

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Collapsed lung
Sponsor
Maxima Medisch Centrum
Enrollment
340
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Maxima Medisch Centrum

Eligibility Criteria

Inclusion Criteria

  • •\- Patients with primary spontaneous pneumothorax (PSP) and referred for surgery
  • •due to recurrence, prolonged air leak (\>\=5 days), accompanied hemothorax or a
  • •profession at risk (diving, polar explorers, working with compressed air). \-
  • •Age \>\= 16 years \- Able to read and understand the Dutch language \- Mentally able
  • •to provide informed consent \- Patients should have a preoperative chest CT scan
  • •in order to exclude evident secondary pneumothorax. Previously made CT scans,
  • •within a time range of maximum 5 years, are accepted.

Exclusion Criteria

  • •\- Previous ipsilateral thoracic surgery (except diagnostic thoracoscopy only)
  • •or ipsilateral thoracic radiotherapy
  • •\- Underlying lung disease that provoked the pneumothorax (secondary
  • •pneumothorax): genetically proven Birt\-Hogg\-Dubé syndrome, periodic
  • •pneumothorax in female patients in reproductive age with known endometriosis
  • •(or known catamenial pneumothorax), pulmonary cystic fibrosis, lungfibrosis,
  • •chronic obstructive pulmonary disease (COPD), active pneumonia, pulmonary
  • •ipsilateral malignancy
  • •\- Contra\-indications for thoracic epidural analgesia (TEA) (infection at skin
  • •site, increased intracranial pressure, non\-correctable coagulopathy, sepsis and

Outcomes

Primary Outcomes

Not specified

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