Study Designed to Optimize the Treatment of Primary Pneumothorax
TOPP
Thoracoscopic Treatment of Primary Pneumothorax - A National Randomised Controlled Trial
1 other identifier
interventional
300
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Mar 2009
Longer than P75 for early_phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 9, 2010
CompletedFirst Posted
Study publicly available on registry
August 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedAugust 16, 2016
August 1, 2016
8.8 years
August 9, 2010
August 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to ipsilateral recurrence
All participants are followed 10 years from the initial discharge via Questionnaires
10 years
Secondary Outcomes (3)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
10 years
Length of hospital stay
up to 10 years
Pain according to NRS scale reported at discharge, at 4 weeks, 1 year, 5 years and 10 years.
up to 10 years
Study Arms (4)
HRCT with bullae, treatment conservative
EXPERIMENTALPatients undergo High-resolution CT scan, and significant bullae are identified (i.e. \> 1 cm). Afterwards randomised to conservative treatment with conventional chest-tube drainage.
HRCT no bullae, treatment conservative
EXPERIMENTALPatients 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.
HRCT with bullae, treatment VATS.
EXPERIMENTALPatients 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.
HRCT no bullae, treatment VATS.
EXPERIMENTALPatients 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.
Interventions
Thoracoscopic bullectomy is performed on all visible bullae, alternatively is no visible bullae, the apex is resected. Then mechanical pleuradesis is performed.
Conventional chest tube insertion.
All surgical participants received an epidural prior to the procedure.The epidural was removed simultaneous with the the chest tube.
All participants included in this study had a HRCT performed.
Eligibility Criteria
You may qualify if:
- First incidence of primary spontaneous pneumothorax.
- 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.
You may not qualify if:
- Age above 40.
- Previously pulmonary og cardiac surgery.
- Pregnant or breastfeeding.
- Patients who do not tolerate anesthetics.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Odense University Hospitallead
- Danish Medical Associationcollaborator
- Danmarks Lungeforeningcollaborator
Study Sites (3)
Research Unit at the Cardiothoracic Department at the University Hospital of Skejby
Aarhus, Central Jutland, 8600, Denmark
Research Unit at the cardiothoracic departement at the University Hospital of Odense
Odense, Fyn, 5690, Denmark
Research Unit at the Cardiothoracic Department af Ålborg Hospital
Aalborg, North Denmark, 9100, Denmark
Related Publications (1)
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.
PMID: 29509892DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Winnie Hedevang Olesen, ph.d.student
Research Unit at the Cardiothoracic Department at the University Hospital of Odense.
- PRINCIPAL INVESTIGATOR
Peter Bjørn Licht, Professor MD
Research Unit at the Cardiothoracic Department at the University Hospital of Odense
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD and Principal investigator
Study Record Dates
First Submitted
August 9, 2010
First Posted
August 15, 2016
Study Start
March 1, 2009
Primary Completion
December 1, 2017
Study Completion
December 1, 2024
Last Updated
August 16, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share