NCT06687629

Best Practice in the Management of Concha Bullosa in FESS Operation

Completed NA Last updated 10 March 2026

What this trial tests

NA trial testing Concha bullosa crushing in Sinusitis in 62 participants. Completed in 31 December 2025.

Timeline

21 March 2018

Primary endpoint
12 July 2023

31 December 2025

Quick facts

Lead sponsor	Helsinki University Central Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	62
Start date	21 March 2018
Primary completion	12 July 2023
Estimated completion	31 December 2025
Sites	1 location across Finland

Drugs / interventions tested

• Concha bullosa crushing
• Concha bullosa resection

Conditions studied

• Sinusitis — all drugs for Sinusitis →
• Sinusitis Bacterial — all drugs for Sinusitis Bacterial →
• Sinusitis Recurrent — all drugs for Sinusitis Recurrent →
• Turbinate; Hypertrophy Mucous Membrane — all drugs for Turbinate; Hypertrophy Mucous Membrane →

Sponsor

Helsinki University Central Hospital

Who can join

18 and older, any sex, with Sinusitis or Sinusitis Bacterial. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.