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Best Practice in the Management of Concha Bullosa in FESS Operation

Best Practice in the Management of Concha Bullosa in FESS Operation

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06687629
Enrollment
62
Registered
2024-11-13
Start date
2018-03-21
Completion date
2025-12-31
Last updated
2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Concha Bullosa, Middle Turbinate, Sinusitis, Sinusitis Bacterial, Sinusitis Recurrent, Turbinate Hypertrophy, Turbinate; Hypertrophy Mucous Membrane

Keywords

concha bullosa, sinusitis, concha bullosa resection, concha bullosa crushing, chronic sinusitis, sinusitis bacterial

Brief 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.

Interventions

PROCEDUREConcha bullosa crushing

Concha bullosa crushing

PROCEDUREConcha bullosa resection

Concha bullosa resection

Sponsors

Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative SNOT-221 yearpostoperative SNOT-22 score

Secondary

MeasureTime frameDescription
LM endoscopy score1 yearLM endoscopy score

Countries

Finland

Contacts

STUDY_DIRECTORMarkus Lilja, PhD

Helsinki University Central Hospital

PRINCIPAL_INVESTIGATORMario Järvekülg, MD

Helsinki University Central Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026