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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Pakistan1 site
  • Shaikh Zayed Hospital, Lahore

    Lahore, Punjab Province, 60000

Other trials in Pakistan

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.

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 groups in NCT07457606
Study groupRoleWhat they receive
partial turbinectomyActive comparatorNot described
Receives: Procedure: partial turbinectomy
mucosal diathermyExperimentalNot described
Receives: Procedure: submucosal diathermy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Nasal Obstruction

    Measured: one month

  2. Incidence of Nasal Pain

    Measured: one month

  3. 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.

  1. First posted9 Mar 2026
  2. Study start27 Sep 2025
  3. Primary completion26 Nov 2025
  4. Study completion25 Dec 2025

Resources

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)
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

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.

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