- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07457606
Turbinectomy: Partial Versus Mucosal Diathermy
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 60000
- Shaikh Zayed Hospital, Lahore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: partial 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
|
|
Experimental: mucosal 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate of Nasal Obstruction
Time Frame: one month
|
one month
|
|
Incidence of Nasal Pain
Time Frame: one month
|
one month
|
|
Rate of Nasal Crusting
Time Frame: one month
|
one month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: mudassar saeed pansota, Assistant Professor of Urology, Shahida Islam Teaching Hospital, Lodhran, Pakistan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PGMI, Lahore
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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