Best Practice in the Management of Concha Bullosa in FESS Operation

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.

Study Overview

• Status: Completed
• Conditions: Sinusitis; Sinusitis Recurrent; Turbinate Hypertrophy; Sinusitis Bacterial; Turbinate; Hypertrophy Mucous Membrane; Concha Bullosa; Middle Turbinate
• Intervention / Treatment: Procedure: Concha bullosa crushing; Procedure: Concha bullosa resection

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00130
      • Helsinki University Hospital Ear Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: crushing; Concha bullosa crushing group	Procedure: Concha bullosa crushing; Concha bullosa crushing
Active Comparator: resection; Concha bullosa resection group	Procedure: Concha bullosa resection; Concha bullosa resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative SNOT-22	postoperative SNOT-22 score	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LM endoscopy score	LM endoscopy score	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotics usage postoperatively	Antibiotics usage postoperatively	1 year

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Study Director: Markus Lilja, PhD, Helsinki University Central Hospital; Principal Investigator: Mario Järvekülg, MD, Helsinki University Central Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2018
• Primary Completion (Actual): July 12, 2023
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 7, 2026
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: chronic sinusitis; sinusitis; concha bullosa; concha bullosa resection; concha bullosa crushing; sinusitis bacterial
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Sinusitis
• Other Study ID Numbers: HUS/66/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: According to the data protection regulations, patients' personal data cannot be shared publicly in Finland.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No