ClinicalTrials.gg
CompletedNCT07457606Updated Mar 9, 2026

Turbinectomy: Partial Versus Mucosal Diathermy

An interventional study of partial turbinectomy and submucosal diathermy in Inferior Turbinate Hypertrophy, sponsored by Shahida Islam Medical Complex. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-09.

Sponsored by Shahida Islam Medical Complex · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Sep 2025, registered Feb 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Inferior Turbinate Hypertrophy

Browse trials for

Keywords

  • turbinectomy
  • partial
  • diathermy
03

In context

Fever

438 studies on the registry are indexed under Fever; 55 are open to participants now.

This study's enrollment of 58 is below the median of 123 across 271 interventional studies indexed under Fever.

Browse Fever studies →

Lead sponsor

Shahida Islam Medical Complex is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • Confirmed diagnosis of inferior turbinate hypertrophy.

      • Persistent nasal obstruction symptoms for over 6 months.
      • Inadequate response to conservative medical treatments like intranasal and antihistamines for at least 3 months

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Active comparator
    partial turbinectomy

    Procedure: partial turbinectomy

  • Experimental
    mucosal diathermy

    Procedure: submucosal diathermy

Interventions

  • Procedurepartial turbinectomy

    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

  • Proceduresubmucosal diathermy

    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

06

What researchers measure

Primary outcomes

  1. Rate of Nasal Obstruction

    Time frame: one month

  2. Incidence of Nasal Pain

    Time frame: one month

  3. Rate of Nasal Crusting

    Time frame: one month

07

Study locations

1 site
  • Shaikh Zayed Hospital, Lahore
    Lahore, Punjab Province 60000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07457606
Lead sponsor
Shahida Islam Medical Complex
Responsible party
Dr Mudassar Saeed Pansota (clinical professor, Shahida Islam Medical Complex) — Principal investigator
First posted
Mar 9, 2026
Start date
Sep 27, 2025
Primary completion
Nov 26, 2025
Completion
Dec 25, 2025
Last update
Mar 9, 2026

Study contacts

mudassar saeed pansota
principal investigator · Assistant Professor of Urology, Shahida Islam Teaching Hospital, Lodhran, Pakistan

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion