Short- and Long-term Effects of Robot-assisted Plication in Diaphragmatic Paralysis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorUppsala County Council, Sweden

About this trial

Diaphragmatic paralysis may lead to severe symptoms such as breathlessness and reduced physical capacity.

Diaphragmatic plication using Robotic-Assisted Thoracic Surgery (RATS) is a minimally invasive surgical technique developed to improve lung function by correcting diaphragmatic elevation.

While its benefits have been reported in retrospective reports, prospective studies are lacking.

This prospective observational cohort study aimsto evaluate the short- and long-term effects of robot-assisted diaphragmatic plication on subjective breathlessness, physical performance, lung function, blood gases, and imaging findings at five Swedish university hospitals: Gothenburg, Linköping, Lund, Umeå, and Uppsala.

Patients will be assessed preoperatively and postoperatively after one to three months and after one and three years.

Eligibility criteria

Qualifiers

Patients with symptomatic unilateral diaphragmatic paralysis persisting for ≥1 year

Patients are scheduled for RATS at thoracic surgery clinics in five Swedish university hospitals (Gothenburg, Linköping, Lund, Umeå, and Uppsala).

Disqualifiers

Inability to complete forms in Swedish

Neuromuscular disease as the cause of diaphragmatic paralysis

Other significant causes of dyspnea

Impaired physical capacity from other causes than diaphragmatic paralysis.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

50 Participants
are grouped into 1 trial group

Sponsors and collaborators

Uppsala County Council, Sweden

Lead sponsor

Uppsala University

Collaborator