The Incidence and Impact of Vocal Cord Dysfunction In Patients Undergoing Thoracic Surgery (NCT02996526) | Clinical Trial Compass
CompletedNot Applicable
The Incidence and Impact of Vocal Cord Dysfunction In Patients Undergoing Thoracic Surgery
Canada173 participantsStarted 2016-09-01
Plain-language summary
Population-based single centre, blinded, prospective cohort study of the impact of recurrent laryngeal nerve (RLN) injury on Thoracic Surgery patients. The principal outcome of interest is the effect of RLN injury on respiratory complications. Voice, swallowing, cardiac and mortality outcomes will also be determined.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All patients undergoing thoracic surgery at Health Sciences Centre Winnipeg. Recruitment will be performed by the thoracic surgeon faculty within the Division of Thoracic Surgery. Written informed consent will be obtained from the patient by an independent research assistant.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Provide signed and dated informed consent form.
* Willing to comply with all study procedures and be available for the duration of the study.
* Male or female, aged 18 and over..
* Have a condition requiring surgical entry into the thoracic cavity
Exclusion Criteria:
* All individuals meeting any of the exclusion criteria at baseline will be excluded from the study. Patients with severely deviated nasal anatomy precluding flexible nasolaryngoscopy Tracheostomy in situ Neurologic or developmental deficits impairing the ability to consent or cooperate with examination
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients with vocal cord dysfunction assessed by nasolaryngoscopy on the first post-operative day