Best Practice in the Management of Concha Bullosa in FESS Operation

NCT ID: NCT06687629

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-21
• Study Completion Date: 2025-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

crushing

Concha bullosa crushing group

Group Type: ACTIVE_COMPARATOR

Concha bullosa crushing

Intervention Type: PROCEDURE

Concha bullosa crushing

resection

Concha bullosa resection group

Group Type: ACTIVE_COMPARATOR

Concha bullosa resection

Intervention Type: PROCEDURE

Concha bullosa resection

Interventions

Concha bullosa crushing

Concha bullosa crushing

Intervention Type: PROCEDURE

Concha bullosa resection

Concha bullosa resection

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mario Järvekülg

specialist doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Markus Lilja, PhD

Role: STUDY_DIRECTOR

Helsinki University Central Hospital

Mario Järvekülg, MD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

Helsinki University Hospital Ear Clinic

Helsinki, Uusimaa, Finland

Countries

Finland

References

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.

Reference Type: BACKGROUND

PMID: 15518100 (View on PubMed)

Other Identifiers

HUS/66/2018

Identifier Type: -

Identifier Source: org_study_id