Medial Flap Coblation Turbinoplasty Versus Submucous Resection

Study Overview
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Brief Summary
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Both submucous resection and medial flap coblation turbinoplasty are equally effective and safe in relieving nasal obstruction and enabling optimal volume reduction with preservation of function of the inferior turbinate. Coblation turbinoplasty has superior outcomes in terms of better healing and less bleeding, postoperative pain and crusting. Medial flap turbinoplasty is a simple, minimally invasive easy to learn procedure with low morbidity and excellent long-lasting results.

Detailed Description
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This prospective, randomized, comparative surgical trial was conducted in the Department of Otorhinolaryngology, Mansoura University, Egypt, over a period of 2 years (March 2020 - March 2022). The study included 90 adult patients with chronic nasal obstruction due to inferior turbinate hypertrophy, and not responding to the usual medical treatment (intranasal corticosteroid therapy for at least 3 months). Patients with other causes of nasal obstruction such as chronic rhinosinusitis, sinonasal tumours and nasal septal deflections were excluded from the study. Additionally, patients with history of previous nasal surgeries were also excluded. All patients of the study (n=90) received prior medical treatment in the form of decongestants and intranasal corticosteroids with no improvement. Patients of the study were randomly allocated into two groups using block randomization method: coblation medial flap turbinoplasty group (n=45), and submucous resection (SMR) group (n=45). The patients were blind to the procedure they had. Informed written consents were obtained from all participants (n=90), and the study was approved by the Mansoura Faculty of Medicine Institutional research board (MFM-IRB: R.22.09.1853). All patients (n=90) were subjected for detailed history taking with special focus on the nasal symptoms. Additionally, an objective assessment for the nasal airways was performed before and after surgery by rigid nasal endoscopic examination without using nasal decongestants. The inferior turbinate grading system that was applied by Camacho et al was adopted in the current study. It was classified into 4 grades: grade 1 (inferior turbinate occupying 0%-25% of total airway space), grade 2 (occupying 26%-50% of total airway space), grade 3 (occupying51%-75% of total airway space), grade 4 (occupying 76%-100% of total airway space). Operative techniques: All surgeries were performed under general anaesthesia. Patients were prepped and draped in the standard fashion for endoscopic sinus surgery, and by using a zero-degree rigid nasal endoscope, under video imaging. Submucous resection (SMR): After infiltration of the inferior turbinate with 1 to 2 ml of 1% lidocaine with 1:100,000 epinephrine solution, an incision was done along the infero-medial surface of the turbinate extending from posterior to anterior. Medial and lateral mucosal flaps were then elevated, followed by resection of the turbinate bone. Then, flaps were returned back into position Medial flap coblation turbinoplasty: Turbinoplasty was performed using Coblation II surgery system (Smith and Nephew, USA) with EVAC 70 wand set to: ablation power 7 and coagulation power 3. After infiltration with 1 to 2 ml of 1% lidocaine with 1:100,000 epinephrine, inferior turbinate in-fracture was done by using a Cottle dissector. The mucous membrane as well as the soft tissues of the lateral side of the inferior turbinate were excised in an anterior to posterior direction using the coblation in ablation mode. The turbinate bone was then dissected from the medial mucosa (raising a medial flap), by a Cottle dissector. The bone was removed, and haemostasis was adequately achieved by using the coblation in the coagulation mode for bleeding points. The medial flap was then repositioned inferiorly and laterally to cover the remining expoNo nasal packing was performed in both groups (n=90). Patients were discharged home on the next postoperative day. Oral antibiotics (amoxicillin-clavulanic acid) were prescribed for one week. Saline nasal wash was prescribed for 2 - 3 weeks postoperatively. Follow up visits were planned on a weekly basis for one month, then after 3 months and 6 months.sed part of the inferior turbinate.

Official Title
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Medial Flap Coblation Turbinoplasty Versus Submucous Resection

Conditions
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Inferior Turbinate Hypertrophy

Intervention / Treatment
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* Procedure: Medial Flap Coblation Turbinoplasty
* Procedure: Submucous Resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients with chronic nasal obstruction due to inferior turbinate hypertrophy not responding to the conventional treatment; mainly intranasal steroid spray for 3 months duratoin. Exclusion Criteria: Patients with other causes of nasal obstruction such as chronic rhinosinusitis, sinonasal tumours and nasal septal deflections

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medial Flap Coblation Turbinoplasty<br> | Procedure: Medial Flap Coblation Turbinoplasty<br>* Reduction of the inferior turbinate to manage inferior turbinate hypertrophy<br>|
| Active Comparator: Submucous Resection<br> | Procedure: Submucous Resection<br>* Submucous Resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of nasal breathing | subjectively assessed preoperatively and postoperatively by using the NOSE scale, objective assessment of the size of the inferior turbinate by endoscope. The inferior turbinate grading system that was applied by Camacho et al was adopted in the current study. It was classified into 4 grades: grade 1 (inferior turbinate occupying 0%-25% of total airway space), grade 2 (occupying 26%-50% of total airway space), grade 3 (occupying51%-75% of total airway space), grade 4 (occupying 76%-100% of total airway space). | within 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative bleeding | it was assessed by using the Boezaart surgical field grading scale as the following: Grade 0: no bleeding 'cadaveric condition', Grade 1: minimal bleeding, no required suction, Grade 2:minimal bleeding, occasional suction is required, Grade 3: minimal bleeding, frequent suction is needed, surgical field is threatened by bleeding few seconds after removal of suction, Grade 4: bleeding is moderate, frequent suction is required and surgical field is threatened by bleeding immediately after removal of suction, Grade 5: bleeding is severe, persistent suction is needed and surgical field is severely threatened by bleeding which can't be controlled by suction | during surgery | 
| Post operative pain | it was assessed by visual analogue scale (VAS), where the patient was asked to score the pain from 1 to 10 and was graded as following; zero: no problem, 1-3: mild problem, 4-7: moderate problem, and 8-10: severe problem. | within 10 days afte surgery | 
| Intra-nasal crustations | it was evaluated according to the endoscopic score of Lund and Kennedy, as the following: Grade 0: Absence of crustations, Grade 1: Mild crustations: partially filling the nasal cavity, Grade 2: Severe crustations: fully filling the nasal cavity. | within 3 months after surgery | 
| Post-operative healing | it was was evaluated also as regard Lund and kennedy, as the following: Good: if there are minimal crustations, fast mucosal re-epithelization, patient feels recovered from nasal symptoms, no nasal synechiae, Moderate: mild to moderate degree of crustations, mucosal re-epithelization, patient feels relief of nasal symptoms, with nasal synechiae, Poor: severe crustations and nasal synechiae, delayed mucosal re-epithelization patient doesn't feel relief of nasal symptoms, persistent inflammations and infection | within 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inferior turbinate; turbinoplasty; submucous resection; medial flap; coblation