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Study Designed to Optimize the Treatment of Primary Pneumothorax

NCT02866305 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2016-08-16

No results posted yet for this study

Summary

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.

Conditions

  • Primary Spontaneous Pneumothorax
  • Pleural Disease

Interventions

PROCEDURE

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.

PROCEDURE

Chest tube insertion

Conventional chest tube insertion.

DRUG

Epidural

All surgical participants received an epidural prior to the procedure.The epidural was removed simultaneous with the the chest tube.

RADIATION

High-resolution Computer Tomography

All participants included in this study had a HRCT performed.

Sponsors & Collaborators

  • Danish Medical Association

    collaborator OTHER

  • Danmarks Lungeforening

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Winnie Hedevang Olesen, ph.d.student · Research Unit at the Cardiothoracic Department at the University Hospital of Odense.

  • Peter Bjørn Licht, Professor MD · Research Unit at the Cardiothoracic Department at the University Hospital of Odense

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2017-12-31
Completion
2024-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02866305 on ClinicalTrials.gov