Medial Flap Coblation Turbinoplasty Versus Submucous Resection
NCT ID: NCT05738512
Last Updated: 2023-02-22
Study Results
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Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2020-03-01
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Medial Flap Coblation Turbinoplasty
Medial Flap Coblation Turbinoplasty
Reduction of the inferior turbinate to manage inferior turbinate hypertrophy
Submucous Resection
Submucous Resection
Submucous Resection
Interventions
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Medial Flap Coblation Turbinoplasty
Reduction of the inferior turbinate to manage inferior turbinate hypertrophy
Submucous Resection
Submucous Resection
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Locations
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Mansoura University faculty of Medicine
Al Mansurah, , Egypt
Countries
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References
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Omura K, Nomura K, Takeda T, Yanagi N, Kuroyanagi H, Yanagihara T, Tanaka Y, Kojima H, Otori N. How I Do It: Inferior Turbinectomy: Modified Techniques for Submucosal Resection. Allergy Rhinol (Providence). 2021 Aug 9;12:21526567211034736. doi: 10.1177/21526567211034736. eCollection 2021 Jan-Dec.
Farmer SE, Eccles R. Chronic inferior turbinate enlargement and the implications for surgical intervention. Rhinology. 2006 Dec;44(4):234-8.
Cavaliere M, Mottola G, Iemma M. Comparison of the effectiveness and safety of radiofrequency turbinoplasty and traditional surgical technique in treatment of inferior turbinate hypertrophy. Otolaryngol Head Neck Surg. 2005 Dec;133(6):972-8. doi: 10.1016/j.otohns.2005.08.006.
Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016.
Camacho M, Zaghi S, Certal V, Abdullatif J, Means C, Acevedo J, Liu S, Brietzke SE, Kushida CA, Capasso R. Inferior turbinate classification system, grades 1 to 4: development and validation study. Laryngoscope. 2015 Feb;125(2):296-302. doi: 10.1002/lary.24923. Epub 2014 Sep 12.
Boezaart AP, van der Merwe J, Coetzee A. Comparison of sodium nitroprusside- and esmolol-induced controlled hypotension for functional endoscopic sinus surgery. Can J Anaesth. 1995 May;42(5 Pt 1):373-6. doi: 10.1007/BF03015479.
Lund VJ, Kennedy DW. Quantification for staging sinusitis. The Staging and Therapy Group. Ann Otol Rhinol Laryngol Suppl. 1995 Oct;167:17-21.
Bergmark RW, Gray ST. Surgical Management of Turbinate Hypertrophy. Otolaryngol Clin North Am. 2018 Oct;51(5):919-928. doi: 10.1016/j.otc.2018.05.008. Epub 2018 Jul 18.
Other Identifiers
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MFM-IRB: R.22.09.1853
Identifier Type: -
Identifier Source: org_study_id
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