CompletedNot Applicable

Best Practice in the Management of Concha Bullosa in FESS Operation

Finland62 participantsStarted 2018-03-21

Plain-language summary

Concha bullosa (CB) refers to the condition where the middle turbinate's interior is aerated (making the turbinate wide and thick). CB can narrow the middle meatus and the ostiomeatal complex. In adults suffering from chronic sinusitis, the prevalence of CB is approximately 34%. The most common treatment method for CB is turbinate crushing. This is considered a conservative treatment that preserves the mucous membranes relatively intact without opening the interior of the turbinate. Another fairly common method is the removal of the lateral part of the bullous middle turbinate. Opening the CB and removing the lateral part of the middle turbinate can lead to adhesions between the middle turbinate and the lateral wall of the nose. These adhesions can impede airflow and narrow or completely close the ostium or the surgically created middle meatal antrostomy. Crushing the CB is technically easier and possibly a less traumatic procedure. However, it is suspected that some of these crushed bullous turbinates may refill. The development of a mucocele is another potential issue. Crushing might be a better option compared to resection in the long term. Preserving the mucous membranes during crushing may reduce the formation of adhesions, which are sometimes seen after resection of the middle turbinate. The purpose of the study is to investigate the long-term benefits and side effects of CB treatment methods. The study will include 60 patients undergoing a basic Functional Endoscopic Sinus Surgery (FESS) procedure due to recurrent or chronic maxillary sinusitis. The patients will be randomized, with 31 undergoing resection and 31 undergoing crushing. Before the procedure, patients will undergo a CT scan (NSO-TT) and symptom evaluation through various questionnaires. All patients will also undergo nasoscopy. One year after the procedure, the patients' conditions will be reassessed (questionnaires, nasoscopy, NSO-TT only if necessary), including the need for revision surgery.

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: * chronic or recurrent rhinosinusitis * 3 months of regular nasal corticosteroid usage * No prior endoscopic procedures of the paranasal sinuses * EPOS criteria for CRS are met: inflammation of the paranasal sinuses with at least 2 symptoms, one of which must be nasal obstruction/congestion or nasal discharge (anterior/posterior): * facial pain/pressure in the facial area * reduced or lost sense of smell SNOT-22 25 or higher * Complications of CRS (e.g., mucocele) * Pregnancy/breastfeeding or plans for them in the near future * Coagulation disorders * Systemic diseases: cystic fibrosis, primary ciliary dysfunction, sarcoidosis, Wegener's granulomatosis * Immunosuppression: diagnosed SAD, CVI, HIV, or use of biological/immunosuppressive drugs * Immunotherapy * Daily use of systemic corticosteroids * Communication issues (non-Finnish-speaking patient, neurological/psychiatric problems) * SNOT-22 score \< 25

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

postoperative SNOT-22

Timeframe: 1 year

Trial details

NCT IDNCT06687629

SponsorHelsinki University Central Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-12

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