CompletedNot Applicable

Nasal Splint and Endoscopic Nasal Septal Repair Surgery

Canada130 participantsStarted 2016-03-24

Plain-language summary

Septoplasty is one of the most performed surgeries in rhinology as a solo procedure, or in combination with sinus surgery. The procedure for septoplasty and postoperative management has evolved over time based on several studies that have been done. The current standard of care in our centre is to conduct a septoplasty using quilting technique and apply Doyle splints in both nostrils to stabilize the septum for 6 days. However these splints are associated with morbidity in the post-op period. The quilting technique was developed to prevent complications and stabilize the septum. This study examines the efficacy of these splints in stabilizing the septum and preventing complications after septoplasty

Who can participate

Age range

19 Years – 75 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: * Patients 19 years and above diagnosed with deviated nasal septum using the Mladina septal deviation scale who are complaining of nasal obstruction and/or sinus disease * These patients will also be undergoing a nasal septoplasty either as a standalone case or as part of endoscopic sinus surgery and/or resection of the inferior turbinates. These surgeries could either be a primary or revision case. Exclusion Criteria: * Patients with sinonasal tumors * Cystic fibrosis or syndromic patients (e.g. Wegeners granulomatosis, immunocompromised) * Patients with autoimmune diseases * Patients who do not understand English language and to understand the purpose, methods and conduct of this study.

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

Mladina

Timeframe: 3 months for every patient

Trial details

NCT IDNCT03575689

SponsorSt. Paul's Hospital, Canada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04-01

View on ClinicalTrials.gov More Septum Deviated trials