Clinical trial NCT06687629: Best Practice in the Management of Concha Bullosa in FESS Operation
Official title: Best Practice in the Management of Concha Bullosa in FESS Operation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sinusitis
Sinusitis Bacterial
Sinusitis Recurrent
Turbinate; Hypertrophy Mucous Membrane
Turbinate Hypertrophy
Concha Bullosa
Middle Turbinate
Keywords: concha bullosa
sinusitis
concha bullosa resection
concha bullosa crushing
chronic sinusitis
sinusitis bacterial
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: postoperative SNOT-22
timeFrame: 1 year
Secondary outcomes:
measure: LM endoscopy score
timeFrame: 1 year
Other outcomes:
measure: Antibiotics usage postoperatively
timeFrame: 1 year
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital Ear Clinic
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital
name: Markus Lilja, PhD
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital
name: Mario Järvekülg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dogru H, Uygur K, Tuz M. Concha bullosa squeezer for turbinoplasty (Dogru forceps). J Otolaryngol. 2004 Apr;33(2):111-3. doi: 10.2310/7070.2004.02112. No abstract available.