Extended Endoscopic Approaches to Non-malignant Maxillary Sinus Lesions Comparative

• Conditions: Approach-Approach Conflict; Maxillary Sinus Disease
• Interventions: Procedure: Modified endoscopic pre-lacrimal approach; Procedure: Endoscopic Modified Medial Maxillectomy; Procedure: endoscopic maxillary mega-antrostomy

• Registration Number: NCT05494099
• Lead Sponsor: Tanta University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-07
• Study First Submitted QC: 2022-08-07
• Last Update Submitted: 2022-08-07
• Study First Posted: 2022-08-09
• Last Update Posted: 2022-08-09
• Study Start: 2022-09
• Primary Completion: 2023-11
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group C (3rd 25 patients)	Modified endoscopic pre-lacrimal approach	The endoscopic prelacrimal recess approach.
Group B (2nd 25 patients)	Endoscopic Modified Medial Maxillectomy	The endoscopic modified medial maxillectomy approach.
Group A (1st 25 patients)	endoscopic maxillary mega-antrostomy	The middle meatal mega-antrostomy approach.

Primary Outcome Measures

Name	Time	Method
Intra-operative Endoscopic Assesment	Intraoperative only	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

Secondary Outcome Measures

Name	Time	Method
Sino-Nasal Outcome Test 22,. Arabic translation and validation (SNOT-22)	3 months	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.

Trial Locations

Locations (1)

Faculty of medicine; 🇪🇬 Tanta, Gharbia Government, Egypt