SinusitisNCT06687629
Best Practice in the Management of Concha Bullosa in FESS Operation
A study testing Concha bullosa crushing and Concha bullosa resection in people with Sinusitis and Sinusitis Bacterial, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinusitis, Sinusitis Bacterial, Sinusitis Recurrent
- What is being tested?
- Concha bullosa crushing and Concha bullosa resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFinland
- Study dates
- 21 Mar 2018to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University Hospital Ear Clinic
Helsinki, Uusimaa, 00130
About this study
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
- Being tested
- Concha bullosa crushing, Concha bullosa resection
- Keywords
- concha bullosa, sinusitis, concha bullosa resection, concha bullosa crushing, chronic sinusitis, sinusitis bacterial
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concha bullosa crushingProcedure or surgery
Concha bullosa crushing
Concha bullosa resectionProcedure or surgery
Concha bullosa resection
| Study group | Role | What they receive |
|---|---|---|
| crushing | Active comparator | Concha bullosa crushing group Receives: Procedure: Concha bullosa crushing |
| resection | Active comparator | Concha bullosa resection group Receives: Procedure: Concha bullosa resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative SNOT-22
postoperative SNOT-22 score
Measured: 1 year
Secondary outcomes (1)
LM endoscopy score
LM endoscopy score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start21 Mar 2018
- Primary completion12 Jul 2023
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SinusitisStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Järvekülg, Helsinki University Central Hospital
- Investigators
- Markus Lilja, PhD, Study director, Helsinki University Central HospitalMario Järvekülg, MD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687629
- Sponsor's protocol ID
- HUS/66/2018
- Status last verified
- Oct 2024
- First submitted
- 12 Nov 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the data protection regulations, patients' personal data cannot be shared publicly in Finland.
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.
PubMed 15518100Jarvekulg M, Virkkula P, Wiksten J, Geneid A, Haapaniemi A, Hytonen M, Lilja M. Crushing Versus Resection of Concha Bullosa as an Adjunct to FESS: Long-Term Randomized Controlled Trial. Laryngoscope. 2026 Jul 30. doi: 10.1002/lary.70778. Online ahead of print.
PubMed 42533380
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Practice in the Management of Concha Bullosa in FESS Operation
- ClinicalTrials.gov ID
- NCT06687629
- Acronym / sponsor ID
- HUS/66/2018
- Conditions
- Sinusitis, Sinusitis Bacterial, Sinusitis Recurrent, Turbinate; Hypertrophy Mucous Membrane, Turbinate Hypertrophy, Concha Bullosa
- Keywords
- concha bullosa, sinusitis, concha bullosa resection, concha bullosa crushing, chronic sinusitis, sinusitis bacterial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| crushing | Active comparator | Procedure: Concha bullosa crushingConcha bullosa crushing group |
| resection | Active comparator | Procedure: Concha bullosa resectionConcha bullosa resection group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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):
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concha bullosa crushingConcha bullosa crushing | Procedure or surgery | crushing |
| Concha bullosa resectionConcha bullosa resection | Procedure or surgery | resection |
Primary outcome
postoperative SNOT-22
Time frame: 1 year
postoperative SNOT-22 score
1 secondary outcome
LM endoscopy score
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background: PubMed 15518100Dogru 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.
- Derived from this study: PubMed 42533380Jarvekulg M, Virkkula P, Wiksten J, Geneid A, Haapaniemi A, Hytonen M, Lilja M. Crushing Versus Resection of Concha Bullosa as an Adjunct to FESS: Long-Term Randomized Controlled Trial. Laryngoscope. 2026 Jul 30. doi: 10.1002/lary.70778. Online ahead of print.
- Individual participant dataSharing planned: No. According to the data protection regulations, patients' personal data cannot be shared publicly in Finland.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Lilja, PhD study director
Helsinki University Central Hospital
Mario Järvekülg, MD principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concha bullosa crushing and Concha bullosa resection in people with Sinusitis and Sinusitis Bacterial, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative SNOT-22 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06687629, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.