Diaphragm Plication in Adults With Phrenic Nerve Paralysis
NCT ID: NCT00689234
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
12 participants
INTERVENTIONAL
2008-04-30
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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A
At time of inclusion randomised in the "no intervention" arm (the subjects will be re-evaluated 6 months later and will get intervention at that time (cross-over protocol)
diaphragm plication 6 months after inclusion
thoracotomy
B
At time of inclusion the subject get the intervention
diaphragm plication at time of inclusion
thoracotomy
Interventions
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diaphragm plication 6 months after inclusion
thoracotomy
diaphragm plication at time of inclusion
thoracotomy
Eligibility Criteria
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Inclusion Criteria
* With reduced VC, at least in supine position and no significant change in VC for at least 6 months
* At the time of randomisation symptomatic patient, defined by one of the following symptoms: not able to sleep in supine position or exertional dyspnoea
Exclusion Criteria
* Other disease that may interfere with the evaluation of pulmonary function or the exercise capacity: COPD, parenchymal lung disease on the thoracic X-ray, documented ischemic heart disease or left heart failure, active rheumatological disease, severe orthopaedic problems,....
* Abnormal neuromuscular clinical investigation (apart from diaphragmatic dysfunction) and/or abnormal electromyography of the limbs compatible with generalized neuromuscular disease
* Known diseases resulting in abnormal blood coagulation
* Proven oncological origine of the phrenic nerve paralysis
* Age below 18 yrs old
18 Years
ALL
No
Sponsors
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KU Leuven
OTHER
Responsible Party
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Marc Decramer
Prof. Dr.
Locations
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University Hospital Gasthuisberg Divisionof Pulmonology
Leuven, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Bertien MA Buyse, MD,Phd
Role: primary
Other Identifiers
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B32220083458 (no sponsor)
Identifier Type: -
Identifier Source: org_study_id