Turbinate; Hypertrophy Mucous MembraneNCT06310083
Endoscopic Submucosal Resection Turbinoplasty VS Turbinectomy
A study testing Submucosal Resection Turbinoplasty Versus Partial Inferior Turbinectomy in people with Turbinate; Hypertrophy Mucous Membrane, run by Ahmed Nabil Selim at 1 site in Egypt.
Trial summary
The aim of our study is to compare endoscopic submucosal resection Turbinoplasty and partial inferior turbinectomy regarding clinical and radiological evaluation and its possible complications in the treatment of Chronic inferior turbinate hypertrophy. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Turbinate; Hypertrophy Mucous Membrane
- What is being tested?
- Submucosal Resection Turbinoplasty Versus Partial Inferior Turbinectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 31 Jan 2024
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients aged between 18 and 45 years complaining with a minimum 3-month duration of nasal obstruction combined with clinical findings of inferior turbinate hypertrophy
Who cannot join
- Patient's Hemoglobin levels are less than 10gm%.
- Patients who were Presented with acute upper respiratory tract infection.
- Patients with other causes of nasal obstruction, e.g.,- allergic nasal polyposis, deviated nasal septum.
- Patients who have nasal tumors.
- Patients who had nasal operations before
- Presence of bleeding disorder.
- Presence of uncontrolled systemic disease.
- During the period of menses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Endoscopic Submucosal Resection Turbinoplasty and Partial Inferior Turbinectomy for Management of Inferior Turbinate Hypertrophy
The aim of our study is to compare endoscopic submucosal resection Turbinoplasty and partial inferior turbinectomy regarding clinical and radiological evaluation and its possible complications in the treatment of Chronic inferior turbinate hypertrophy.
Read the detailed description
The inferior turbinate (IT) plays a vital function in nose physiology by regulating the temperature and humidity of inhaled air and filtering foreign particles through the mucociliary clearance system.
One of the most common manifestations of chronic rhinitis is nasal obstruction. Nasal obstruction occurs as a result of submucosal or mucosal hypertrophy associated with increased vascularity of the inferior turbinate.
The location, size, and vasoactive capabilities of the inferior turbinate relegate it as a key player in airway resistance. Multiple pathologic processes may alter the gross and microscopic structure of the inferior turbinates, including septal deviation and inflammatory disorders such as allergic rhinitis, nonallergic rhinitis, and chronic rhinosinusitis. These disorders in turn lead to histological differences in terms of hypertrophy and hyperplasia, distorted cilia, inflammatory cell infiltrates, and mucosal thickening with subsequent macroscopic changes and symptomatic obstruction.
Surgical reduction of the inferior turbinate is warranted to relieve the nasal block caused by the hypertrophied inferior turbinates. Surgical reduction of the inferior turbinate involves removal of the mucosa, soft erectile tissue, and turbinate bone. Different techniques have been applied to increase the nasal airway passage, such as conventional turbinectomy, laser turbinectomy, cryoturbinectomy, electrocautery turbinectomy, conventional Turbinoplasty, microdebrider Turbinoplasty, coblation Turbinoplasty, radiofrequency Turbinoplasty, and ultrasound Turbinoplasty. Conventional turbinectomy (total or partial) is considered very effective in relieving nasal block. Due to the excessive loss of tissue (bone and mucosa), the postoperative complications include excessive bleeding requiring blood transfusion, crusting, pain, and prolonged recovery period. Hence, a more mucosal-friendly approach is preferred; the Turbinoplasty procedure, which resects either soft tissue or bone or both with preservation of the mucosa.
Conventional Turbinoplasty is designed to remove the nonfunctional obstructive part of the turbinate while preserving the functional medial mucosa, which plays the key role in the warming and humidification of air through the nasal passages. Performed endoscopically, inferior Turbinoplasty has the advantage over the other turbinate procedures by preserving sufficient mucosa, while removing adequate obstructed tissue to improve the airway significantly. The other term used for this technique is "submucosal resection", as a reference to its submucosal dissection procedure.
- Conditions
- Turbinate; Hypertrophy Mucous Membrane
- Being tested
- Submucosal Resection Turbinoplasty Versus Partial Inferior Turbinectomy
- Keywords
- turbinoplasty, Turbinectomy, Turbinate Hypertrophy, Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submucosal Resection Turbinoplasty Versus Partial Inferior TurbinectomyProcedure or surgery
The study's Participants Were Randomly classified in two groups Interventional Group, applied for Submucosal Resection Turbinoplasty and the controlled group who were applied for Partial Inferior Turbinectomy
| Study group | Role | What they receive |
|---|---|---|
| Submucosal Rescetion Turbinoplasty | Active comparator | participants in this group were applied for Endoscopic submucosal resection Turbinoplasty Receives: Procedure: Submucosal Resection Turbinoplasty Versus Partial Inferior Turbinectomy |
| Partial Inferior Turbinectomy | Placebo comparator | participants in this group were applied for Partial Inferior Turbinectomy Receives: Procedure: Submucosal Resection Turbinoplasty Versus Partial Inferior Turbinectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Obstruction
questionnaire entitled Nasal Obstruction Syndrome Evaluation, known as NOSE score is used to evaluate the improvement in nasal obstruction This score has 5 questions about life quality. Each receives a score from 0 to 4 and these are summed up and multiplied by 20. The total NOSE score ranges from 0 to 100
Measured: 3 months
Nasal Discharge
rhinorrhea conventional visual analogue scale (VAS) is used to evaluate nasal Discharge. Patients were asked to rank their symptoms on a scale of 0-10, with 0 denoting no symptoms and 10 denoting the most severe symptoms, with mild symptoms scoring 0-3, moderate symptoms scoring 4-7, and severe symptoms scoring 8-10
Measured: 3 months
Crustations
an endoscopic score of "Lund and Kennedy" is used to evaluate postoperative Crustations Grade 0 Absence of crustations Grade 1 Mild crustations: partially filling the nasal cavity Grade 2 Severe crustations: fully filling the nasal cavity
Measured: 3 months
Secondary outcomes (3)
intra operative blood loss
Boezaart surgical field grading scale is used to evaluate intra-operative bleeding (primary), Grade 1 Minimal bleeding, no suction is needed Grade 2 Minimal bleeding, occasional suction is needed Grade 3 Slight bleeding, frequent suction is needed, and surgical field is threatened by bleeding a few seconds after removal of suction Grade 4 Bleeding is moderate, frequent suction is needed, and the surgical field is threatened by bleeding immediately after removal of suction Grade 5 Bleeding is severe, persistent suction is needed, and the surgical field is severely threatened by bleeding that cannot be controlled by suction
Measured: intraoperative
Duration of operation (Minutes )
Measurement the duration of operation by Minutes
Measured: intraoperative
Hyposmia
percentage of patients whose Complaint ( Hyposmia ) Was improved postoperatively
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Feb 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Turbinate; Hypertrophy Mucous MembraneStudies of the same condition, open and under way.
- 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
- Model description
- A total of 40 patients were enrolled in the study. The patients were randomly classified into two groups, with 20 in each group. Group A (study group): who applied for Endoscopic submucosal resection Turbinoplasty. Group B (control group): Who applied for partial inferior turbinectomy.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Nabil Selim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Nabil Selim, Al-Azhar University
- Investigators
- Sabry H Easa, MD, Study chair, Al-Azhar University Hospital of Assiut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310083
- Sponsor's protocol ID
- SMR for Turbinate Hypertrophy
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Al Awad, M. K., & Ali, M. Y. (2022). Inferior Turbinate Hypertrophy Histopathology in Allergic Rhinitis Patients and in Patients with Deviated Nasal Septum. Egyptian Journal of Ear, Nose, Throat and Allied Sciences, 23(23). https://doi.org/10.21608/ejentas.2022.141170.1518
Abdullah B, Singh S. Surgical Interventions for Inferior Turbinate Hypertrophy: A Comprehensive Review of Current Techniques and Technologies. Int J Environ Res Public Health. 2021 Mar 26;18(7):3441. doi: 10.3390/ijerph18073441.
PubMed 33810309Thamboo, A., Ayoub, N., Maul, X., & Nayak, J. (2021a). The Inferior Turbinate: Role in Normal Respiration and Airway Obstruction. In Current Otorhinolaryngology Reports (Vol. 9, Issue 4, 98 pp. 383-388). Springer Science and Business Media B.V. https://doi.org/10.1007/s40136-021- 00370-6
Lee KC, Cho JM, Kim SK, Lim KR, Lee SY, Park SS. The Efficacy of Coblator in Turbinoplasty. Arch Craniofac Surg. 2017 Jun;18(2):82-88. doi: 10.7181/acfs.2017.18.2.82. Epub 2017 Jun 26.
PubMed 28913312Elshipli NA, El-Sisi HE, El-Fattah AMA, Al-Saddeik MAE. Outcome comparison of submucous resection versus combined submucous diathermy and outfracture for treatment of inferior turbinate hypertrophy. Eur Arch Otorhinolaryngol. 2021 Oct;278(10):3827-3837. doi: 10.1007/s00405-021-06663-2. Epub 2021 Feb 13.
PubMed 33582852Thirugnanamani, R., Sahadevan, S., Ramabhadraiah, A. K., Menon P, A., & M Prabhu, R. (2021). Benefits of Turbinectomy vs Turbinoplasty - A Prospective Study. Bengal Journal of Otolaryngology and Head Neck Surgery, 29(2). https://doi.org/10.47210/bjohns.2021.v29i2.435
Amhimmid, R. H., Mohamed, W., Amin, B., Mohamed, A. M., & Odabasha, A. E. (2022). Endoscopic Inferior Turbinoplasty Versus Radiofrequency Ablation for Treatment of Inferior Turbinate Hypertrophy. In The Egyptian Journal of Hospital Medicine (Vol. 88). https://ejhm.journals.ekb.eg/
Lund VJ, Kennedy DW. Quantification for staging sinusitis. The Staging and Therapy Group. Ann Otol Rhinol Laryngol Suppl. 1995 Oct;167:17-21.
PubMed 7574265Easa SH, Farghaly TM, Elswaby ESS, Selim A. Endoscopic Submucosal Resection Turbinoplasty and Partial Inferior Turbinectomy for Management of Inferior Turbinate Hypertrophy: A Randomized Clinical Trial. Indian J Otolaryngol Head Neck Surg. 2024 Dec;76(6):5080-5090. doi: 10.1007/s12070-024-04926-y. Epub 2024 Aug 8.
PubMed 39559133
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Endoscopic Submucosal Resection Turbinoplasty and Partial Inferior Turbinectomy for Management of Inferior Turbinate Hypertrophy
- ClinicalTrials.gov ID
- NCT06310083
- Acronym / sponsor ID
- SMR for Turbinate Hypertrophy
- Conditions
- Turbinate; Hypertrophy Mucous Membrane
- Keywords
- turbinoplasty, Turbinectomy, Turbinate Hypertrophy, Endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ahmed Nabil SelimUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 15 Mar 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.
The aim of our study is to compare endoscopic submucosal resection Turbinoplasty and partial inferior turbinectomy regarding clinical and radiological evaluation and its possible complications in the treatment of Chronic inferior turbinate hypertrophy.
Detailed description
The inferior turbinate (IT) plays a vital function in nose physiology by regulating the temperature and humidity of inhaled air and filtering foreign particles through the mucociliary clearance system.
One of the most common manifestations of chronic rhinitis is nasal obstruction. Nasal obstruction occurs as a result of submucosal or mucosal hypertrophy associated with increased vascularity of the inferior turbinate.
The location, size, and vasoactive capabilities of the inferior turbinate relegate it as a key player in airway resistance. Multiple pathologic processes may alter the gross and microscopic structure of the inferior turbinates, including septal deviation and inflammatory disorders such as allergic rhinitis, nonallergic rhinitis, and chronic rhinosinusitis. These disorders in turn lead to histological differences in terms of hypertrophy and hyperplasia, distorted cilia, inflammatory cell infiltrates, and mucosal thickening with subsequent macroscopic changes and symptomatic obstruction.
Surgical reduction of the inferior turbinate is warranted to relieve the nasal block caused by the hypertrophied inferior turbinates. Surgical reduction of the inferior turbinate involves removal of the mucosa, soft erectile tissue, and turbinate bone. Different techniques have been applied to increase the nasal airway passage, such as conventional turbinectomy, laser turbinectomy, cryoturbinectomy, electrocautery turbinectomy, conventional Turbinoplasty, microdebrider Turbinoplasty, coblation Turbinoplasty, radiofrequency Turbinoplasty, and ultrasound Turbinoplasty. Conventional turbinectomy (total or partial) is considered very effective in relieving nasal block. Due to the excessive loss of tissue (bone and mucosa), the postoperative complications include excessive bleeding requiring blood transfusion, crusting, pain, and prolonged recovery period. Hence, a more mucosal-friendly approach is preferred; the Turbinoplasty procedure, which resects either soft tissue or bone or both with preservation of the mucosa.
Conventional Turbinoplasty is designed to remove the nonfunctional obstructive part of the turbinate while preserving the functional medial mucosa, which plays the key role in the warming and humidification of air through the nasal passages. Performed endoscopically, inferior Turbinoplasty has the advantage over the other turbinate procedures by preserving sufficient mucosa, while removing adequate obstructed tissue to improve the airway significantly. The other term used for this technique is "submucosal resection", as a reference to its submucosal dissection procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 40 patients were enrolled in the study. The patients were randomly classified into two groups, with 20 in each group. Group A (study group): who applied for Endoscopic submucosal resection Turbinoplasty. Group B (control group): Who applied for partial inferior turbinectomy.
| Arm | Type | Receives |
|---|---|---|
| Submucosal Rescetion Turbinoplasty | Active comparator | Procedure: Submucosal Resection Turbinoplasty Versus Partial Inferior Turbinectomyparticipants in this group were applied for Endoscopic submucosal resection Turbinoplasty |
| Partial Inferior Turbinectomy | Placebo comparator | Procedure: Submucosal Resection Turbinoplasty Versus Partial Inferior Turbinectomyparticipants in this group were applied for Partial Inferior Turbinectomy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All patients aged between 18 and 45 years complaining with a minimum 3-month duration of nasal obstruction combined with clinical findings of inferior turbinate hypertrophy
Key exclusion criteria (8 listed)
- Patient's Hemoglobin levels are less than 10gm%.
- Patients who were Presented with acute upper respiratory tract infection.
- Patients with other causes of nasal obstruction, e.g.,- allergic nasal polyposis, deviated nasal septum.
- Patients who have nasal tumors.
- Patients who had nasal operations before
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 |
|---|---|---|
| Submucosal Resection Turbinoplasty Versus Partial Inferior TurbinectomyThe study's Participants Were Randomly classified in two groups Interventional Group, applied for Submucosal Resection Turbinoplasty and the controlled group who were applied for Partial Inferior Turbinectomy | Procedure or surgery | Partial Inferior Turbinectomy, Submucosal Rescetion Turbinoplasty |
Primary outcome
Nasal Obstruction
Time frame: 3 months
questionnaire entitled Nasal Obstruction Syndrome Evaluation, known as NOSE score is used to evaluate the improvement in nasal obstruction This score has 5 questions about life quality. Each receives a score from 0 to 4 and these are summed up and multiplied by 20. The total NOSE score ranges from 0 to 100
Nasal Discharge
Time frame: 3 months
rhinorrhea conventional visual analogue scale (VAS) is used to evaluate nasal Discharge. Patients were asked to rank their symptoms on a scale of 0-10, with 0 denoting no symptoms and 10 denoting the most severe symptoms, with mild symptoms scoring 0-3, moderate symptoms scoring 4-7, and severe symptoms scoring 8-10
Crustations
Time frame: 3 months
an endoscopic score of "Lund and Kennedy" is used to evaluate postoperative Crustations Grade 0 Absence of crustations Grade 1 Mild crustations: partially filling the nasal cavity Grade 2 Severe crustations: fully filling the nasal cavity
3 secondary outcomes
intra operative blood loss
Time frame: intraoperative
Duration of operation (Minutes )
Time frame: intraoperative
Hyposmia
Time frame: 3 months
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 15 Mar 2024.
- BackgroundAl Awad, M. K., & Ali, M. Y. (2022). Inferior Turbinate Hypertrophy Histopathology in Allergic Rhinitis Patients and in Patients with Deviated Nasal Septum. Egyptian Journal of Ear, Nose, Throat and Allied Sciences, 23(23). https://doi.org/10.21608/ejentas.2022.141170.1518
- Background: PubMed 33810309Abdullah B, Singh S. Surgical Interventions for Inferior Turbinate Hypertrophy: A Comprehensive Review of Current Techniques and Technologies. Int J Environ Res Public Health. 2021 Mar 26;18(7):3441. doi: 10.3390/ijerph18073441.
- BackgroundThamboo, A., Ayoub, N., Maul, X., & Nayak, J. (2021a). The Inferior Turbinate: Role in Normal Respiration and Airway Obstruction. In Current Otorhinolaryngology Reports (Vol. 9, Issue 4, 98 pp. 383-388). Springer Science and Business Media B.V. https://doi.org/10.1007/s40136-021- 00370-6
- Background: PubMed 28913312Lee KC, Cho JM, Kim SK, Lim KR, Lee SY, Park SS. The Efficacy of Coblator in Turbinoplasty. Arch Craniofac Surg. 2017 Jun;18(2):82-88. doi: 10.7181/acfs.2017.18.2.82. Epub 2017 Jun 26.
- Results publication: PubMed 33582852Elshipli NA, El-Sisi HE, El-Fattah AMA, Al-Saddeik MAE. Outcome comparison of submucous resection versus combined submucous diathermy and outfracture for treatment of inferior turbinate hypertrophy. Eur Arch Otorhinolaryngol. 2021 Oct;278(10):3827-3837. doi: 10.1007/s00405-021-06663-2. Epub 2021 Feb 13.
- Results publicationThirugnanamani, R., Sahadevan, S., Ramabhadraiah, A. K., Menon P, A., & M Prabhu, R. (2021). Benefits of Turbinectomy vs Turbinoplasty - A Prospective Study. Bengal Journal of Otolaryngology and Head Neck Surgery, 29(2). https://doi.org/10.47210/bjohns.2021.v29i2.435
- Results publicationAmhimmid, R. H., Mohamed, W., Amin, B., Mohamed, A. M., & Odabasha, A. E. (2022). Endoscopic Inferior Turbinoplasty Versus Radiofrequency Ablation for Treatment of Inferior Turbinate Hypertrophy. In The Egyptian Journal of Hospital Medicine (Vol. 88). https://ejhm.journals.ekb.eg/
- 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.
- Derived from this study: PubMed 39559133Easa SH, Farghaly TM, Elswaby ESS, Selim A. Endoscopic Submucosal Resection Turbinoplasty and Partial Inferior Turbinectomy for Management of Inferior Turbinate Hypertrophy: A Randomized Clinical Trial. Indian J Otolaryngol Head Neck Surg. 2024 Dec;76(6):5080-5090. doi: 10.1007/s12070-024-04926-y. Epub 2024 Aug 8.
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.
Sabry H Easa, MD study chair
Al-Azhar University Hospital of Assiut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Submucosal Resection Turbinoplasty Versus Partial Inferior Turbinectomy in people with Turbinate; Hypertrophy Mucous Membrane, run by Ahmed Nabil Selim 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 8 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 15 Mar 2024. 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. Some participants in this study may receive a placebo. 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?
Nasal Obstruction (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT06310083, which also lists 9 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 15 Mar 2024.