Extended Endoscopic Approaches to Non-malignant Maxillary Sinus Lesions Comparative

Study Overview
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Brief Summary
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The aim of this study is to compare the outcomes of endoscopic middle meatus mega-antrostomy, endoscopic pre-lacrimal recess approach and endoscopic modified medial maxillectomy regarding: 1.Assessment of the accessibility of each approach to visualize and reach the different walls and recesses of the maxillary sinus. 2. Any intraoperative or postoperative complications. 3. Any post-operative recurrence or residue detected by endoscopic examination. 4. Symptomatic relief by pre- and post-operative Sino-Nasal Outcome Test 22, Arabic translation and validation (SNOT-22) which is a reliable and valid outcome measure for CRS patients.

Detailed Description
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A wide range of surgical ways to reach maxillary sinus. Historically, maxillary sinus was entered by external approaches such as lateral rhinotomy etc. in benign or malignant diseases, but now endoscopic approaches have recently replaced external approaches as the standard of treatment of maxillary sinus diseases due to reduced morbidity, improved visualisation and low recurrence rates of benign tumours. Studies found that middle meatal antrostomy only provided access to about 24-34 percent of the total sinus volume only and rarely offer access to the anterior wall and sinus floor, regardless of the angled instruments used .Endoscopic maxillary mega-antrostomy is typically used as a revision procedure in patients with maxillary sinusitis refractory to surgery. The resulting antrostomy is greatly enlarged and allows the sinus to drain more easily by gravity, as well as admitting topical therapy more readily . Radical endoscopic medial maxillectomy is indicated for the resection of benign and malignant sinonasal neoplasms when wide surgical access and tumor clearance is required However, resection of the inferior turbinate head may contributes to nasal crusting, dryness and empty nose syndrome ,so modified endoscopic medial maxillectomy gives better access to the maxillary sinus, with preserving the head of the inferior turbinate Pre-lacrimal recess approach allows for direct access to the sinus with 0-degree endoscopes and straight instruments, and thus improved visualisation of its contents especially anterior sinus wall, better handling of tools with preservation of inferior turbinate and nasolacrimal duct It is difficult to select suitable approach to maxillary sinus to ensure proper intraoperative visualization and better access to disease with fewer complications that is why we do this study.

Official Title
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Extended Endoscopic Approaches to Non-malignant Maxillary Sinus Lesions Comparative Study

Conditions
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Maxillary Sinus Disease, Approach-Approach Conflict

Intervention / Treatment
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* Procedure: endoscopic maxillary mega-antrostomy
* Procedure: Endoscopic Modified Medial Maxillectomy
* Procedure: Modified endoscopic pre-lacrimal approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inflammatory disease of the maxillary sinus in the context of allergic or infective rhinosinusitis, with or without formation of inflammatory polyps. When such cases fail to respond to maximal medical therapy. Benign and locally malignant neoplasms of the maxillary sinus (ex: inverted papilloma) which are planned to be removed by extended endoscopic approach. Exclusion Criteria: Patients who are unfit to surgery (ex: with bleeding disorders or severe systemic diseases). Patients who refuse surgery or difficult to be followed up. Patients with minimal lesions who respond to medical treatment. Patients with malignant tumor of maxillary sinus proved by histopathology.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A (1st 25 patients)<br>The middle meatal mega-antrostomy approach. | Procedure: endoscopic maxillary mega-antrostomy<br>* a mucosal sparing technique that facilitates mucus clearance and sinus irrigation in terminally dysfunctional maxillary sinuses. EMMA involves extending the antrostomy through the posterior half of the inferior turbinate down to the floor of the nose, creating a significantly enlarged antrostomy.<br>|
| Group B (2nd 25 patients)<br>The endoscopic modified medial maxillectomy approach. | Procedure: Endoscopic Modified Medial Maxillectomy<br>* In this approach, the maxillary sinus is operated upon, while the inferior turbinate and nasolacrimal duct are preserved.<br>|
| Group C (3rd 25 patients)<br>The endoscopic prelacrimal recess approach. | Procedure: Modified endoscopic pre-lacrimal approach<br>* The approach involves making a curved mucosal incision on the lateral nasal wall just anterior to the head of the inferior turbinate. The nasal mucosa was then undermined off the lateral nasal wall. The maxillary sinus was entered with a chisel, and the medial bony wall of the maxillary sinus removed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative Endoscopic Assesment | Assessment of the accessibility of endoscopic approach which will be evaluated by using different types of telescopes to visualize and reach the different walls and recesses of the maxillary sinus | Intraoperative only | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sino-Nasal Outcome Test 22,. Arabic translation and validation (SNOT-22) | Assess the effect of each endoscopic approach on recurrence rate of maxillary sinus lesions. regular endoscopic examination first visit after one week, second after 3 weeks and the third after 3 months. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopic approaches, maxillary sinus