Inferior Turbinate HypertrophyNCT05738512
Medial Flap Coblation Turbinoplasty Versus Submucous Resection
A study testing Medial Flap Coblation Turbinoplasty and Submucous Resection in people with Inferior Turbinate Hypertrophy, run by Mansoura University at 1 site in Egypt.
Trial summary
Both submucous resection and medial flap coblation turbinoplasty are equally effective and safe in relieving nasal obstruction and enabling optimal volume reduction with preservation of function of the inferior turbinate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inferior Turbinate Hypertrophy
- What is being tested?
- Medial Flap Coblation Turbinoplasty and Submucous Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 31 Dec 2022
- 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
- adult patients with chronic nasal obstruction due to inferior turbinate hypertrophy not responding to the conventional treatment; mainly intranasal steroid spray for 3 months duratoin.
Who cannot join
- Patients with other causes of nasal obstruction such as chronic rhinosinusitis, sinonasal tumours and nasal septal deflections
Trial locations and contacts
1 site in 1 country.
About this study
Both submucous resection and medial flap coblation turbinoplasty are equally effective and safe in relieving nasal obstruction and enabling optimal volume reduction with preservation of function of the inferior turbinate. Coblation turbinoplasty has superior outcomes in terms of better healing and less bleeding, postoperative pain and crusting. Medial flap turbinoplasty is a simple, minimally invasive easy to learn procedure with low morbidity and excellent long-lasting results.
Read the detailed description
This prospective, randomized, comparative surgical trial was conducted in the Department of Otorhinolaryngology, Mansoura University, Egypt, over a period of 2 years (March 2020 - March 2022). The study included 90 adult patients with chronic nasal obstruction due to inferior turbinate hypertrophy, and not responding to the usual medical treatment (intranasal corticosteroid therapy for at least 3 months).
Patients with other causes of nasal obstruction such as chronic rhinosinusitis, sinonasal tumours and nasal septal deflections were excluded from the study. Additionally, patients with history of previous nasal surgeries were also excluded. All patients of the study (n=90) received prior medical treatment in the form of decongestants and intranasal corticosteroids with no improvement.
Patients of the study were randomly allocated into two groups using block randomization method: coblation medial flap turbinoplasty group (n=45), and submucous resection (SMR) group (n=45). The patients were blind to the procedure they had. Informed written consents were obtained from all participants (n=90), and the study was approved by the Mansoura Faculty of Medicine Institutional research board (MFM-IRB: R.22.09.1853).
All patients (n=90) were subjected for detailed history taking with special focus on the nasal symptoms.
Additionally, an objective assessment for the nasal airways was performed before and after surgery by rigid nasal endoscopic examination without using nasal decongestants. The inferior turbinate grading system that was applied by Camacho et al was adopted in the current study. It was classified into 4 grades: grade 1 (inferior turbinate occupying 0%-25% of total airway space), grade 2 (occupying 26%-50% of total airway space), grade 3 (occupying51%-75% of total airway space), grade 4 (occupying 76%-100% of total airway space).
Operative techniques:
All surgeries were performed under general anaesthesia. Patients were prepped and draped in the standard fashion for endoscopic sinus surgery, and by using a zero-degree rigid nasal endoscope, under video imaging.
Submucous resection (SMR):
After infiltration of the inferior turbinate with 1 to 2 ml of 1% lidocaine with 1:100,000 epinephrine solution, an incision was done along the infero-medial surface of the turbinate extending from posterior to anterior. Medial and lateral mucosal flaps were then elevated, followed by resection of the turbinate bone. Then, flaps were returned back into position
Medial flap coblation turbinoplasty:
Turbinoplasty was performed using Coblation II surgery system (Smith and Nephew, USA) with EVAC 70 wand set to: ablation power 7 and coagulation power 3. After infiltration with 1 to 2 ml of 1% lidocaine with 1:100,000 epinephrine, inferior turbinate in-fracture was done by using a Cottle dissector. The mucous membrane as well as the soft tissues of the lateral side of the inferior turbinate were excised in an anterior to posterior direction using the coblation in ablation mode. The turbinate bone was then dissected from the medial mucosa (raising a medial flap), by a Cottle dissector. The bone was removed, and haemostasis was adequately achieved by using the coblation in the coagulation mode for bleeding points. The medial flap was then repositioned inferiorly and laterally to cover the remining expoNo nasal packing was performed in both groups (n=90). Patients were discharged home on the next postoperative day. Oral antibiotics (amoxicillin-clavulanic acid) were prescribed for one week. Saline nasal wash was prescribed for 2 - 3 weeks postoperatively. Follow up visits were planned on a weekly basis for one month, then after 3 months and 6 months.sed part of the inferior turbinate.
- Conditions
- Inferior Turbinate Hypertrophy
- Being tested
- Medial Flap Coblation Turbinoplasty, Submucous Resection
- Keywords
- Inferior turbinate; turbinoplasty; submucous resection; medial flap; coblation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medial Flap Coblation TurbinoplastyProcedure or surgery
Reduction of the inferior turbinate to manage inferior turbinate hypertrophy
Submucous ResectionProcedure or surgery
Submucous Resection
| Study group | Role | What they receive |
|---|---|---|
| Medial Flap Coblation Turbinoplasty | Active comparator | Not described Receives: Procedure: Medial Flap Coblation Turbinoplasty |
| Submucous Resection | Active comparator | Not described Receives: Procedure: Submucous Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of nasal breathing
subjectively assessed preoperatively and postoperatively by using the NOSE scale, objective assessment of the size of the inferior turbinate by endoscope. The inferior turbinate grading system that was applied by Camacho et al was adopted in the current study. It was classified into 4 grades: grade 1 (inferior turbinate occupying 0%-25% of total airway space), grade 2 (occupying 26%-50% of total airway space), grade 3 (occupying51%-75% of total airway space), grade 4 (occupying 76%-100% of total airway space).
Measured: within 6 months after surgery
Secondary outcomes (4)
Intra-operative bleeding
it was assessed by using the Boezaart surgical field grading scale as the following: Grade 0: no bleeding 'cadaveric condition', Grade 1: minimal bleeding, no required suction, Grade 2:minimal bleeding, occasional suction is required, Grade 3: minimal bleeding, frequent suction is needed, surgical field is threatened by bleeding few seconds after removal of suction, Grade 4: bleeding is moderate, frequent suction is required and surgical field is threatened by bleeding immediately after removal of suction, Grade 5: bleeding is severe, persistent suction is needed and surgical field is severely threatened by bleeding which can't be controlled by suction
Measured: during surgery
Post operative pain
it was assessed by visual analogue scale (VAS), where the patient was asked to score the pain from 1 to 10 and was graded as following; zero: no problem, 1-3: mild problem, 4-7: moderate problem, and 8-10: severe problem.
Measured: within 10 days afte surgery
Intra-nasal crustations
it was evaluated according to the endoscopic score of "Lund and Kennedy", as the following: Grade 0: Absence of crustations, Grade 1: Mild crustations: partially filling the nasal cavity, Grade 2: Severe crustations: fully filling the nasal cavity.
Measured: within 3 months after surgery
Post-operative healing
it was was evaluated also as regard Lund and kennedy, as the following: Good: if there are minimal crustations, fast mucosal re-epithelization, patient feels recovered from nasal symptoms, no nasal synechiae, Moderate: mild to moderate degree of crustations, mucosal re-epithelization, patient feels relief of nasal symptoms, with nasal synechiae, Poor: severe crustations and nasal synechiae, delayed mucosal re-epithelization patient doesn't feel relief of nasal symptoms, persistent inflammations and infection
Measured: within 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Mar 2020
- Primary completion1 Mar 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Inferior Turbinate HypertrophyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738512
- Sponsor's protocol ID
- MFM-IRB: R.22.09.1853
- Status last verified
- Feb 2023
- First submitted
- 13 Feb 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Omura K, Nomura K, Takeda T, Yanagi N, Kuroyanagi H, Yanagihara T, Tanaka Y, Kojima H, Otori N. How I Do It: Inferior Turbinectomy: Modified Techniques for Submucosal Resection. Allergy Rhinol (Providence). 2021 Aug 9;12:21526567211034736. doi: 10.1177/21526567211034736. eCollection 2021 Jan-Dec.
PubMed 34408915Farmer SE, Eccles R. Chronic inferior turbinate enlargement and the implications for surgical intervention. Rhinology. 2006 Dec;44(4):234-8.
PubMed 17216738Cavaliere M, Mottola G, Iemma M. Comparison of the effectiveness and safety of radiofrequency turbinoplasty and traditional surgical technique in treatment of inferior turbinate hypertrophy. Otolaryngol Head Neck Surg. 2005 Dec;133(6):972-8. doi: 10.1016/j.otohns.2005.08.006.
PubMed 16360523Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016.
PubMed 14990910Camacho M, Zaghi S, Certal V, Abdullatif J, Means C, Acevedo J, Liu S, Brietzke SE, Kushida CA, Capasso R. Inferior turbinate classification system, grades 1 to 4: development and validation study. Laryngoscope. 2015 Feb;125(2):296-302. doi: 10.1002/lary.24923. Epub 2014 Sep 12.
PubMed 25215619Boezaart AP, van der Merwe J, Coetzee A. Comparison of sodium nitroprusside- and esmolol-induced controlled hypotension for functional endoscopic sinus surgery. Can J Anaesth. 1995 May;42(5 Pt 1):373-6. doi: 10.1007/BF03015479.
PubMed 7614641Lund VJ, Kennedy DW. Quantification for staging sinusitis. The Staging and Therapy Group. Ann Otol Rhinol Laryngol Suppl. 1995 Oct;167:17-21.
PubMed 7574265Bergmark RW, Gray ST. Surgical Management of Turbinate Hypertrophy. Otolaryngol Clin North Am. 2018 Oct;51(5):919-928. doi: 10.1016/j.otc.2018.05.008. Epub 2018 Jul 18.
PubMed 30029923
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medial Flap Coblation Turbinoplasty Versus Submucous Resection
- ClinicalTrials.gov ID
- NCT05738512
- Acronym / sponsor ID
- MFM-IRB: R.22.09.1853
- Conditions
- Inferior Turbinate Hypertrophy
- Keywords
- Inferior turbinate; turbinoplasty; submucous resection; medial flap; coblation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Feb 2023 (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.
Both submucous resection and medial flap coblation turbinoplasty are equally effective and safe in relieving nasal obstruction and enabling optimal volume reduction with preservation of function of the inferior turbinate. Coblation turbinoplasty has superior outcomes in terms of better healing and less bleeding, postoperative pain and crusting. Medial flap turbinoplasty is a simple, minimally invasive easy to learn procedure with low morbidity and excellent long-lasting results.
Detailed description
This prospective, randomized, comparative surgical trial was conducted in the Department of Otorhinolaryngology, Mansoura University, Egypt, over a period of 2 years (March 2020 - March 2022). The study included 90 adult patients with chronic nasal obstruction due to inferior turbinate hypertrophy, and not responding to the usual medical treatment (intranasal corticosteroid therapy for at least 3 months).
Patients with other causes of nasal obstruction such as chronic rhinosinusitis, sinonasal tumours and nasal septal deflections were excluded from the study. Additionally, patients with history of previous nasal surgeries were also excluded. All patients of the study (n=90) received prior medical treatment in the form of decongestants and intranasal corticosteroids with no improvement.
Patients of the study were randomly allocated into two groups using block randomization method: coblation medial flap turbinoplasty group (n=45), and submucous resection (SMR) group (n=45). The patients were blind to the procedure they had. Informed written consents were obtained from all participants (n=90), and the study was approved by the Mansoura Faculty of Medicine Institutional research board (MFM-IRB: R.22.09.1853).
All patients (n=90) were subjected for detailed history taking with special focus on the nasal symptoms.
Additionally, an objective assessment for the nasal airways was performed before and after surgery by rigid nasal endoscopic examination without using nasal decongestants. The inferior turbinate grading system that was applied by Camacho et al was adopted in the current study. It was classified into 4 grades: grade 1 (inferior turbinate occupying 0%-25% of total airway space), grade 2 (occupying 26%-50% of total airway space), grade 3 (occupying51%-75% of total airway space), grade 4 (occupying 76%-100% of total airway space).
Operative techniques:
All surgeries were performed under general anaesthesia. Patients were prepped and draped in the standard fashion for endoscopic sinus surgery, and by using a zero-degree rigid nasal endoscope, under video imaging.
Submucous resection (SMR):
After infiltration of the inferior turbinate with 1 to 2 ml of 1% lidocaine with 1:100,000 epinephrine solution, an incision was done along the infero-medial surface of the turbinate extending from posterior to anterior. Medial and lateral mucosal flaps were then elevated, followed by resection of the turbinate bone. Then, flaps were returned back into position
Medial flap coblation turbinoplasty:
Turbinoplasty was performed using Coblation II surgery system (Smith and Nephew, USA) with EVAC 70 wand set to: ablation power 7 and coagulation power 3. After infiltration with 1 to 2 ml of 1% lidocaine with 1:100,000 epinephrine, inferior turbinate in-fracture was done by using a Cottle dissector. The mucous membrane as well as the soft tissues of the lateral side of the inferior turbinate were excised in an anterior to posterior direction using the coblation in ablation mode. The turbinate bone was then dissected from the medial mucosa (raising a medial flap), by a Cottle dissector. The bone was removed, and haemostasis was adequately achieved by using the coblation in the coagulation mode for bleeding points. The medial flap was then repositioned inferiorly and laterally to cover the remining expoNo nasal packing was performed in both groups (n=90). Patients were discharged home on the next postoperative day. Oral antibiotics (amoxicillin-clavulanic acid) were prescribed for one week. Saline nasal wash was prescribed for 2 - 3 weeks postoperatively. Follow up visits were planned on a weekly basis for one month, then after 3 months and 6 months.sed part of the inferior turbinate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medial Flap Coblation Turbinoplasty | Active comparator | Procedure: Medial Flap Coblation Turbinoplasty |
| Submucous Resection | Active comparator | Procedure: Submucous Resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients with chronic nasal obstruction due to inferior turbinate hypertrophy not responding to the conventional treatment; mainly intranasal steroid spray for 3 months duratoin.
Key exclusion criteria (1 listed)
- Patients with other causes of nasal obstruction such as chronic rhinosinusitis, sinonasal tumours and nasal septal deflections
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 |
|---|---|---|
| Medial Flap Coblation TurbinoplastyReduction of the inferior turbinate to manage inferior turbinate hypertrophy | Procedure or surgery | Medial Flap Coblation Turbinoplasty |
| Submucous ResectionSubmucous Resection | Procedure or surgery | Submucous Resection |
Primary outcome
improvement of nasal breathing
Time frame: within 6 months after surgery
subjectively assessed preoperatively and postoperatively by using the NOSE scale, objective assessment of the size of the inferior turbinate by endoscope. The inferior turbinate grading system that was applied by Camacho et al was adopted in the current study. It was classified into 4 grades: grade 1 (inferior turbinate occupying 0%-25% of total airway space), grade 2 (occupying 26%-50% of total airway space), grade 3 (occupying51%-75% of total airway space), grade 4 (occupying 76%-100% of total airway space).
4 secondary outcomes
Intra-operative bleeding
Time frame: during surgery
Post operative pain
Time frame: within 10 days afte surgery
Intra-nasal crustations
Time frame: within 3 months after surgery
Post-operative healing
Time frame: within 3 months after surgery
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 22 Feb 2023.
- Results publication: PubMed 34408915Omura K, Nomura K, Takeda T, Yanagi N, Kuroyanagi H, Yanagihara T, Tanaka Y, Kojima H, Otori N. How I Do It: Inferior Turbinectomy: Modified Techniques for Submucosal Resection. Allergy Rhinol (Providence). 2021 Aug 9;12:21526567211034736. doi: 10.1177/21526567211034736. eCollection 2021 Jan-Dec.
- Results publication: PubMed 17216738Farmer SE, Eccles R. Chronic inferior turbinate enlargement and the implications for surgical intervention. Rhinology. 2006 Dec;44(4):234-8.
- Results publication: PubMed 16360523Cavaliere M, Mottola G, Iemma M. Comparison of the effectiveness and safety of radiofrequency turbinoplasty and traditional surgical technique in treatment of inferior turbinate hypertrophy. Otolaryngol Head Neck Surg. 2005 Dec;133(6):972-8. doi: 10.1016/j.otohns.2005.08.006.
- Results publication: PubMed 14990910Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016.
- Results publication: PubMed 25215619Camacho M, Zaghi S, Certal V, Abdullatif J, Means C, Acevedo J, Liu S, Brietzke SE, Kushida CA, Capasso R. Inferior turbinate classification system, grades 1 to 4: development and validation study. Laryngoscope. 2015 Feb;125(2):296-302. doi: 10.1002/lary.24923. Epub 2014 Sep 12.
- Results publication: PubMed 7614641Boezaart AP, van der Merwe J, Coetzee A. Comparison of sodium nitroprusside- and esmolol-induced controlled hypotension for functional endoscopic sinus surgery. Can J Anaesth. 1995 May;42(5 Pt 1):373-6. doi: 10.1007/BF03015479.
- Results publication: PubMed 7574265Lund VJ, Kennedy DW. Quantification for staging sinusitis. The Staging and Therapy Group. Ann Otol Rhinol Laryngol Suppl. 1995 Oct;167:17-21.
- Results publication: PubMed 30029923Bergmark RW, Gray ST. Surgical Management of Turbinate Hypertrophy. Otolaryngol Clin North Am. 2018 Oct;51(5):919-928. doi: 10.1016/j.otc.2018.05.008. Epub 2018 Jul 18.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medial Flap Coblation Turbinoplasty and Submucous Resection in people with Inferior Turbinate Hypertrophy, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 1 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 22 Feb 2023. 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 Egypt. 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?
improvement of nasal breathing (time frame: within 6 months after surgery). 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 NCT05738512, which also lists 8 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 22 Feb 2023.