Inferior Turbinate HypertrophyNCT07457606
Turbinectomy: Partial Versus Mucosal Diathermy
A study testing partial turbinectomy and submucosal diathermy in people with Inferior Turbinate Hypertrophy, run by Shahida Islam Medical Complex at 1 site in Pakistan.
Trial summary
Objectives: To compare the outcomes of partial turbinectomy versus mucosal diathermy in patients with inferior turbinate hypertrophy. Methodology: The ENT Department at Sheikh Zayed Hospital in Lahore carried out this non-randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Inferior Turbinate Hypertrophy
- What is being tested?
- partial turbinectomy and submucosal diathermy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Sep 2025to 25 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Confirmed diagnosis of inferior turbinate hypertrophy.
- Persistent nasal obstruction symptoms for over 6 months.
- Inadequate response to conservative medical treatments like intranasal corticosteroids and antihistamines for at least 3 months
Who cannot join
- • Causes of nasal obstruction other than nasal polyps, septal deviation, sinusitis, or other major sinonasal diseases.
- Uncontrolled allergic rhinitis or undergoing immunotherapy.
- Previous nasal or turbinate surgery.
- Systemic diseases affecting nasal mucosa such as Wegener's granulomatosis, sarcoidosis, or cystic fibrosis.
- Pregnancy or breastfeeding.
- Bleeding disorders or use of anticoagulant therapy.
- Inability to adhere to the study protocol or cognitive impairments affecting understanding and compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Outcomes of Partial Turbinectomy Versus Mucosal Diathermy in Patients With Inferior Turbinate Hypertrophy
Objectives: To compare the outcomes of partial turbinectomy versus mucosal diathermy in patients with inferior turbinate hypertrophy.
Methodology: The ENT Department at Sheikh Zayed Hospital in Lahore carried out this non-randomized controlled study. Total 60 adults between the ages of 18 and 60 who have been diagnosed with inferior turbinate hypertrophy were included. Septal deviation, or other major sinonasal diseases; uncontrolled allergic rhinitis; prior nasal or turbinate surgery were excluded. In group A patients partial inferior turbinectomy (PIT) was done while in group B, submucosal diathermy (SMD) was done. A 10-point Visual Analogue Scale (VAS) was used to measure nose pain on the first postoperative day and at the one-month follow-up. Nasal obstruction scores (Grades 0-3) were assessed both before and after surgery at one and three months. Using Lund and Kennedy's standardized grading method, nasal crusting was assessed. At three-month follow-up visits, tissue healing quality was evaluated.
Read the detailed description
Study design: Randomized controlled trail Study Setting: Department of Otolaryngology, Sheikh Zayed Hospital Lahore. Study duration: Six months after approval of synopsis. Sampling technique: Non-probability consecutive sampling technique. Sample size: A sample size of 58 (29 in each group) is calculated by assuming the proportion of good healing 60% for PIT and 84% for SMD taking confidence interval of 95%, and power 80%. (8) It was calculated using OpenEpi.com.
Sample selection
Inclusion Criteria:
- Adults aged 18 to 60 years.
- Confirmed diagnosis of inferior turbinate hypertrophy.
- Persistent nasal obstruction symptoms for over 6 months.
- Inadequate response to conservative medical treatments like intranasal corticosteroids and antihistamines for at least 3 months.
Exclusion Criteria:
- Causes of nasal obstruction other than nasal polyps, septal deviation, sinusitis, or other major sinonasal diseases.
- Uncontrolled allergic rhinitis or undergoing immunotherapy.
- Previous nasal or turbinate surgery.
- Systemic diseases affecting nasal mucosa such as Wegener's granulomatosis, sarcoidosis, or cystic fibrosis.
- Pregnancy or breastfeeding.
- Bleeding disorders or use of anticoagulant therapy.
- Inability to adhere to the study protocol or cognitive impairments affecting understanding and compliance.
Data collection procedure Upon obtaining approval from the Institutional Review Board and the College of Physicians and Surgeons, the study will be initiated. Written informed consent will be taken from all participants. Eligible participants will be selected through detailed ENT examination, medical history evaluation, and radiological imaging (CT scans in coronal, sagittal, and axial views with 2 mm slices) to confirm inferior turbinate hypertrophy. Preoperative nasal obstruction severity will be assessed using a structured Nasal Obstruction Score (Grades 0-3). Enrolled patients will then be randomized into two groups using the lottery method: Group A (Partial Inferior Turbinectomy) and Group B (Submucosal Diathermy).
All procedures will be conducted under general anesthesia with orotracheal intubation. To reduce bleeding and improve visibility, noradrenaline (1:200,000)-soaked cotton pledgets will be placed in both nasal cavities for about 5 minutes before starting the procedure.
Group A - Partial Inferior Turbinectomy (PIT): After achieving adequate anesthesia and decongestion, the inferior turbinate will be visualized using a nasal speculum or endoscope. The medial one-third of the hypertrophied turbinate, including both the mucosal covering and underlying bony structure, will be carefully removed using turbinectomy scissors. The resection will be limited to the anterior two-thirds of the turbinate, avoiding injury to the posterior end. Bleeding points will be controlled using bipolar cautery or nasal packing as needed.
Group B - Submucosal Diathermy (SMD): Once the turbinate is exposed, an insulated diathermy needle will be inserted into the submucosal layer at the anterior end of the inferior turbinate. The needle will be advanced along the turbinate's length, staying close to the bone. A low-voltage coagulation current will be applied during withdrawal of the needle, typically in two to three passes to cover the superior, middle, and inferior aspects of the turbinate. This causes shrinkage of the submucosal tissue while keeping the outer mucosa mostly intact. Hemostasis will be ensured before the procedure is completed.
In both groups, nasal cavities will be packed with antibiotic-soaked ribbon gauze, which will be removed after 48 hours. A controlled coagulation current of 70 watts will be delivered as the needle is withdrawn slowly, with 2-3 passes performed until visible mucosal blanching and shrinkage are achieved. Hemostasis will be ensured intraoperatively, and bilateral nasal packing with antibiotic-impregnated ribbon gauze will be applied postoperatively for 48 hours.
Postoperative management will include analgesics, antibiotics, and systemic decongestants. Patients will be instructed to avoid nasal blowing and manipulation. After removal of nasal packs at 48 hours, nasal saline irrigation will be prescribed for one month to facilitate healing and comfort. All the complications will be managed according to the standard guideline protocols.
Outcome assessments will be systematically conducted as per operational definitions and protocols at designated intervals: nasal pain will be assessed on postoperative day 1 and at 1-month follow-up using a 10-point Visual Analogue Scale (VAS). Nasal obstruction scores (Grades 0-3) will be evaluated preoperatively and postoperatively at 1 month and 3 months through structured patient interviews. Hemorrhage severity (minimal, moderate, severe) will be clinically assessed and documented within 48 hours postoperatively through direct visual inspection of nasal packing by the consultant ENT surgeon. Nasal crusting will be evaluated endoscopically at postoperative intervals of 2 weeks, 1 month, and 3 months, employing Lund and Kennedy's standardized grading system. Tissue healing quality will similarly be assessed via diagnostic nasal endoscopy using Lund and Kennedy's criteria at 1-month and 3-month follow-up visits. Data will be recorded using data collection proforma.
Statistical Analysis Data will be analyzed using SPSS version 26.0. Descriptive statistics will summarize demographic and baseline clinical characteristics including age, gender, and duration of nasal obstruction symptoms. Categorical variables such as postoperative nasal obstruction grade, nasal pain category, crusting grade, hemorrhage severity, and tissue healing grade will be expressed as frequencies and percentages. Continuous variables, such as VAS scores for pain and nasal obstruction, will be presented as mean ± standard deviation. Comparisons between the two treatment groups-Partial Inferior Turbinectomy (PIT) and Submucosal Diathermy (SMD)-will be performed using the Chi-square test for categorical outcomes and the Independent Samples t-test for continuous variables. Stratification will be done for potential confounding factors including age and gender. Within-group comparisons of pre- and postoperative VAS scores for nasal obstruction and pain will be analyzed using paired t-tests. A p-value of <0.05 will be considered statistically significant for all analyses.
- Conditions
- Inferior Turbinate Hypertrophy
- Being tested
- partial turbinectomy, submucosal diathermy
- Keywords
- turbinectomy, partial, diathermy
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partial turbinectomyProcedure or surgery
After achieving adequate anesthesia and decongestion, the inferior turbinate will be visualized using a nasal speculum or endoscope. The medial one-third of the hypertrophied turbinate, including both the mucosal covering and underlying bony structure, will be carefully removed using turbinectomy scissors. The resection will be limited to the anterior two-thirds of the turbinate, avoiding injury to the posterior end. Bleeding points will be controlled using bipolar cautery or nasal packing as needed
submucosal diathermyProcedure or surgery
Once the turbinate is exposed, an insulated diathermy needle will be inserted into the submucosal layer at the anterior end of the inferior turbinate. The needle will be advanced along the turbinate's length, staying close to the bone. A low-voltage coagulation current will be applied during withdrawal of the needle, typically in two to three passes to cover the superior, middle, and inferior aspects of the turbinate. This causes shrinkage of the submucosal tissue while keeping the outer mucosa mostly intact. Hemostasis will be ensured before the procedure is completed
| Study group | Role | What they receive |
|---|---|---|
| partial turbinectomy | Active comparator | Not described Receives: Procedure: partial turbinectomy |
| mucosal diathermy | Experimental | Not described Receives: Procedure: submucosal diathermy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Nasal Obstruction
Measured: one month
Incidence of Nasal Pain
Measured: one month
Rate of Nasal Crusting
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start27 Sep 2025
- Primary completion26 Nov 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inferior Turbinate HypertrophyStudies 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
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahida Islam Medical Complex
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mudassar Saeed Pansota, Shahida Islam Medical Complex
- Investigators
- mudassar saeed pansota, Principal investigator, Assistant Professor of Urology, Shahida Islam Teaching Hospital, Lodhran, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457606
- Sponsor's protocol ID
- PGMI, Lahore
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes of Partial Turbinectomy Versus Mucosal Diathermy in Patients With Inferior Turbinate Hypertrophy
- ClinicalTrials.gov ID
- NCT07457606
- Acronym / sponsor ID
- PGMI, Lahore
- Conditions
- Inferior Turbinate Hypertrophy
- Keywords
- turbinectomy, partial, diathermy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Shahida Islam Medical ComplexUniversity, hospital or other
- Study start
- 27 Sep 2025 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 9 Mar 2026 (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.
Objectives: To compare the outcomes of partial turbinectomy versus mucosal diathermy in patients with inferior turbinate hypertrophy.
Methodology: The ENT Department at Sheikh Zayed Hospital in Lahore carried out this non-randomized controlled study. Total 60 adults between the ages of 18 and 60 who have been diagnosed with inferior turbinate hypertrophy were included. Septal deviation, or other major sinonasal diseases; uncontrolled allergic rhinitis; prior nasal or turbinate surgery were excluded. In group A patients partial inferior turbinectomy (PIT) was done while in group B, submucosal diathermy (SMD) was done. A 10-point Visual Analogue Scale (VAS) was used to measure nose pain on the first postoperative day and at the one-month follow-up. Nasal obstruction scores (Grades 0-3) were assessed both before and after surgery at one and three months. Using Lund and Kennedy's standardized grading method, nasal crusting was assessed. At three-month follow-up visits, tissue healing quality was evaluated.
Detailed description
Study design: Randomized controlled trail Study Setting: Department of Otolaryngology, Sheikh Zayed Hospital Lahore. Study duration: Six months after approval of synopsis. Sampling technique: Non-probability consecutive sampling technique. Sample size: A sample size of 58 (29 in each group) is calculated by assuming the proportion of good healing 60% for PIT and 84% for SMD taking confidence interval of 95%, and power 80%. (8) It was calculated using OpenEpi.com.
Sample selection
Inclusion Criteria:
- Adults aged 18 to 60 years.
- Confirmed diagnosis of inferior turbinate hypertrophy.
- Persistent nasal obstruction symptoms for over 6 months.
- Inadequate response to conservative medical treatments like intranasal corticosteroids and antihistamines for at least 3 months.
Exclusion Criteria:
- Causes of nasal obstruction other than nasal polyps, septal deviation, sinusitis, or other major sinonasal diseases.
- Uncontrolled allergic rhinitis or undergoing immunotherapy.
- Previous nasal or turbinate surgery.
- Systemic diseases affecting nasal mucosa such as Wegener's granulomatosis, sarcoidosis, or cystic fibrosis.
- Pregnancy or breastfeeding.
- Bleeding disorders or use of anticoagulant therapy.
- Inability to adhere to the study protocol or cognitive impairments affecting understanding and compliance.
Data collection procedure Upon obtaining approval from the Institutional Review Board and the College of Physicians and Surgeons, the study will be initiated. Written informed consent will be taken from all participants. Eligible participants will be selected through detailed ENT examination, medical history evaluation, and radiological imaging (CT scans in coronal, sagittal, and axial views with 2 mm slices) to confirm inferior turbinate hypertrophy. Preoperative nasal obstruction severity will be assessed using a structured Nasal Obstruction Score (Grades 0-3). Enrolled patients will then be randomized into two groups using the lottery method: Group A (Partial Inferior Turbinectomy) and Group B (Submucosal Diathermy).
All procedures will be conducted under general anesthesia with orotracheal intubation. To reduce bleeding and improve visibility, noradrenaline (1:200,000)-soaked cotton pledgets will be placed in both nasal cavities for about 5 minutes before starting the procedure.
Group A - Partial Inferior Turbinectomy (PIT): After achieving adequate anesthesia and decongestion, the inferior turbinate will be visualized using a nasal speculum or endoscope. The medial one-third of the hypertrophied turbinate, including both the mucosal covering and underlying bony structure, will be carefully removed using turbinectomy scissors. The resection will be limited to the anterior two-thirds of the turbinate, avoiding injury to the posterior end. Bleeding points will be controlled using bipolar cautery or nasal packing as needed.
Group B - Submucosal Diathermy (SMD): Once the turbinate is exposed, an insulated diathermy needle will be inserted into the submucosal layer at the anterior end of the inferior turbinate. The needle will be advanced along the turbinate's length, staying close to the bone. A low-voltage coagulation current will be applied during withdrawal of the needle, typically in two to three passes to cover the superior, middle, and inferior aspects of the turbinate. This causes shrinkage of the submucosal tissue while keeping the outer mucosa mostly intact. Hemostasis will be ensured before the procedure is completed.
In both groups, nasal cavities will be packed with antibiotic-soaked ribbon gauze, which will be removed after 48 hours. A controlled coagulation current of 70 watts will be delivered as the needle is withdrawn slowly, with 2-3 passes performed until visible mucosal blanching and shrinkage are achieved. Hemostasis will be ensured intraoperatively, and bilateral nasal packing with antibiotic-impregnated ribbon gauze will be applied postoperatively for 48 hours.
Postoperative management will include analgesics, antibiotics, and systemic decongestants. Patients will be instructed to avoid nasal blowing and manipulation. After removal of nasal packs at 48 hours, nasal saline irrigation will be prescribed for one month to facilitate healing and comfort. All the complications will be managed according to the standard guideline protocols.
Outcome assessments will be systematically conducted as per operational definitions and protocols at designated intervals: nasal pain will be assessed on postoperative day 1 and at 1-month follow-up using a 10-point Visual Analogue Scale (VAS). Nasal obstruction scores (Grades 0-3) will be evaluated preoperatively and postoperatively at 1 month and 3 months through structured patient interviews. Hemorrhage severity (minimal, moderate, severe) will be clinically assessed and documented within 48 hours postoperatively through direct visual inspection of nasal packing by the consultant ENT surgeon. Nasal crusting will be evaluated endoscopically at postoperative intervals of 2 weeks, 1 month, and 3 months, employing Lund and Kennedy's standardized grading system. Tissue healing quality will similarly be assessed via diagnostic nasal endoscopy using Lund and Kennedy's criteria at 1-month and 3-month follow-up visits. Data will be recorded using data collection proforma.
Statistical Analysis Data will be analyzed using SPSS version 26.0. Descriptive statistics will summarize demographic and baseline clinical characteristics including age, gender, and duration of nasal obstruction symptoms. Categorical variables such as postoperative nasal obstruction grade, nasal pain category, crusting grade, hemorrhage severity, and tissue healing grade will be expressed as frequencies and percentages. Continuous variables, such as VAS scores for pain and nasal obstruction, will be presented as mean ± standard deviation. Comparisons between the two treatment groups-Partial Inferior Turbinectomy (PIT) and Submucosal Diathermy (SMD)-will be performed using the Chi-square test for categorical outcomes and the Independent Samples t-test for continuous variables. Stratification will be done for potential confounding factors including age and gender. Within-group comparisons of pre- and postoperative VAS scores for nasal obstruction and pain will be analyzed using paired t-tests. A p-value of <0.05 will be considered statistically significant for all analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| partial turbinectomy | Active comparator | Procedure: partial turbinectomy |
| mucosal diathermy | Experimental | Procedure: submucosal diathermy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Confirmed diagnosis of inferior turbinate hypertrophy.
Key exclusion criteria (7 listed)
- • Causes of nasal obstruction other than nasal polyps, septal deviation, sinusitis, or other major sinonasal diseases.
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 |
|---|---|---|
| partial turbinectomyAfter achieving adequate anesthesia and decongestion, the inferior turbinate will be visualized using a nasal speculum or endoscope. The medial one-third of the hypertrophied turbinate, including both the mucosal covering and underlying bony structure, will be carefully removed using turbinectomy scissors. The resection will be limited to the anterior two-thirds of the turbinate, avoiding injury to the posterior end. Bleeding points will be controlled using bipolar cautery or nasal packing as needed | Procedure or surgery | partial turbinectomy |
| submucosal diathermyOnce the turbinate is exposed, an insulated diathermy needle will be inserted into the submucosal layer at the anterior end of the inferior turbinate. The needle will be advanced along the turbinate's length, staying close to the bone. A low-voltage coagulation current will be applied during withdrawal of the needle, typically in two to three passes to cover the superior, middle, and inferior aspects of the turbinate. This causes shrinkage of the submucosal tissue while keeping the outer mucosa mostly intact. Hemostasis will be ensured before the procedure is completed | Procedure or surgery | mucosal diathermy |
Primary outcome
Rate of Nasal Obstruction
Time frame: one month
Incidence of Nasal Pain
Time frame: one month
Rate of Nasal Crusting
Time frame: one month
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 9 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Inferior Turbinate Hypertrophy
Recruiting
Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China
Nasal Obstruction Due to Inferior Turbinate Hypertrophy
Not yet recruiting
Evaluation of the Outcome of Septoplasty With or Without Inferior Turbinate Reduction
Deviated Nasal Septum, Nasal Obstruction Septal Deviation Compensatory Inferior Turbinate Hypertrophy
Recruiting
Facilitating Surgical Choice in Patient With Chronic Hypertrophic Rhinitis Using a Patient Decision Aid
Allergic Rhinitis
Active, not recruiting
Traditional vs. Posterior Nasal Radiofrequency Ablation for Chronic Rhinitis
Nasal Obstruction, Chronic Rhinitis
Recruiting
Efficacy of Lavender Aromatherapy on Anxiety and Pain Reduction During Awake Otolaryngologic Procedures
Inferior Turbinate Hypertrophy, Chronic Rhinosinusitis (CRS)
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.
mudassar saeed pansota principal investigator
Assistant Professor of Urology, Shahida Islam Teaching Hospital, Lodhran, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing partial turbinectomy and submucosal diathermy in people with Inferior Turbinate Hypertrophy, run by Shahida Islam Medical Complex at 1 site in Pakistan.
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 3 inclusion and 7 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 9 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 Pakistan. 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?
Rate of Nasal Obstruction (time frame: one month). 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?
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 9 Mar 2026.