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Medial Flap Coblation Turbinoplasty Versus Submucous Resection

Primary Purpose

Inferior Turbinate Hypertrophy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Medial Flap Coblation Turbinoplasty
Submucous Resection
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inferior Turbinate Hypertrophy focused on measuring Inferior turbinate; turbinoplasty; submucous resection; medial flap; coblation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mansoura University faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Medial Flap Coblation Turbinoplasty

Submucous Resection

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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.
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.
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

Full Information

First Posted
February 13, 2023
Last Updated
February 21, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05738512
Brief Title
Medial Flap Coblation Turbinoplasty Versus Submucous Resection
Official Title
Medial Flap Coblation Turbinoplasty Versus Submucous Resection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inferior Turbinate Hypertrophy
Keywords
Inferior turbinate; turbinoplasty; submucous resection; medial flap; coblation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medial Flap Coblation Turbinoplasty
Arm Type
Active Comparator
Arm Title
Submucous Resection
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Medial Flap Coblation Turbinoplasty
Intervention Description
Reduction of the inferior turbinate to manage inferior turbinate hypertrophy
Intervention Type
Procedure
Intervention Name(s)
Submucous Resection
Intervention Description
Submucous Resection
Primary Outcome Measure Information:
Title
improvement of nasal breathing
Description
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).
Time Frame
within 6 months after surgery
Secondary Outcome Measure Information:
Title
Intra-operative bleeding
Description
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
Time Frame
during surgery
Title
Post operative pain
Description
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.
Time Frame
within 10 days afte surgery
Title
Intra-nasal crustations
Description
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.
Time Frame
within 3 months after surgery
Title
Post-operative healing
Description
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
Time Frame
within 3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mansoura University faculty of Medicine
City
Mansoura
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34408915
Citation
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.
Results Reference
result
PubMed Identifier
17216738
Citation
Farmer SE, Eccles R. Chronic inferior turbinate enlargement and the implications for surgical intervention. Rhinology. 2006 Dec;44(4):234-8.
Results Reference
result
PubMed Identifier
16360523
Citation
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.
Results Reference
result
PubMed Identifier
14990910
Citation
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.
Results Reference
result
PubMed Identifier
25215619
Citation
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.
Results Reference
result
PubMed Identifier
7614641
Citation
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.
Results Reference
result
PubMed Identifier
7574265
Citation
Lund VJ, Kennedy DW. Quantification for staging sinusitis. The Staging and Therapy Group. Ann Otol Rhinol Laryngol Suppl. 1995 Oct;167:17-21.
Results Reference
result
PubMed Identifier
30029923
Citation
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.
Results Reference
result

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Medial Flap Coblation Turbinoplasty Versus Submucous Resection

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