Skip to main content
OpenTrials
Completed

NCT Number: NCT06687629

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital Ear Clinic

Helsinki, Uusimaa, 00130, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Concha bullosa crushing

Procedure

Concha bullosa crushing

Concha bullosa resection

Procedure

Concha bullosa resection

Primary outcomes

  1. postoperative SNOT-22

    Time frame: 1 year

    postoperative SNOT-22 score

Secondary outcomes

  1. LM endoscopy score

    Time frame: 1 year

    LM endoscopy score

Other outcomes

  1. Antibiotics usage postoperatively

    Time frame: 1 year

    Antibiotics usage postoperatively

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2025
First posted
Nov 13, 2024
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.