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
This trial does not accept healthy volunteersQualifiers
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 population
Patients with unilateral diaphragmatic paralysis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 1 trial groupGroup A: Patients accepted for Robot-assisted diaphragmatic plication
Trial outcomes
Primary outcomes
1
6-minute walking distance (6MWD).
The patients are asked to walk as far as possible on a flat, straight surface for six minutes, and the total distance walked is measured.
Time frame
From enrollment to end of observation att 3 years.Secondary outcomes
1
The modified Borg Scale
A tool with a range from 0 to 10 used to measure an individual's perceived level of breathlessness or muscle fatigue during physical activity, where 0 represents no breathlessness, and 10 represents maximal breathlessness
Time frame
From enrollment to end of observation att 3 years.2
The modified Medical Research Council (mMRC) dyspnea scale
The mMRC is used to assess the severity of breathlessness. The scale ranges from 0 to 4, with higher scores indicating more significant breathlessness
Time frame
From enrollment to end of observation att 3 years.3
The Dyspnea-12 questionnaire
The Dyspnea-12questionnaire is used to measure the severity and quality of breathlessness in individuals with respiratory or cardiovascular conditions. It assesses dyspnea's physical and emotional aspects, providing a comprehensive picture of how breathlessness affects a person's life. It consists of 12 items, each with a scale range between 0 (no dyspnea) and 3 (severe dyspnea)
Time frame
From enrollment to end of observation att 3 years.4
The EQ-5D questionnaire
The EQ-5D is one of the most widely used tools for assessing health-related quality of life. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These dimensions create a descriptive profile that can be converted into a single summary index, where a score of 1.0 indicates perfect health. Additionally, the tool includes a Visual Analog Scale (VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health), for self-assessment of overall health status
Time frame
From enrollment to end of observation att 3 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Uppsala County Council, Sweden
Lead sponsor
Uppsala University
Collaborator
Source ClinicalTrials.gov
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