Clinical trial NCT05494099: Extended Endoscopic Approaches to Non-malignant Maxillary Sinus Lesions Comparative
Official title: Extended Endoscopic Approaches to Non-malignant Maxillary Sinus Lesions Comparative Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Maxillary Sinus Disease
Approach-Approach Conflict
Keywords: maxillary sinus
endoscopic approaches
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic rhinosinusitis who not respond to medical treatment and are planned to be operated by endoscopic sinus surgery.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intra-operative Endoscopic Assesment
timeFrame: Intraoperative only
Secondary outcomes:
measure: Sino-Nasal Outcome Test 22,. Arabic translation and validation (SNOT-22)
timeFrame: 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of medicine
state: Gharbia Government
Study officials:
affiliation: Tanta University Hospital, Egypt.
name: Hassan Mu Hegazy, MD
role: STUDY_DIRECTOR
affiliation: Tanta University Hospital, Egypt.
name: Ahmed Mo Gamea, MD
role: STUDY_DIRECTOR
affiliation: Tanta University Hospital, Egypt.
name: Mohamed Os Tomom, MD
role: STUDY_DIRECTOR
References:
citation: Goudakos JK, Blioskas S, Nikolaou A, Vlachtsis K, Karkos P, Markou KD. Endoscopic Resection of Sinonasal Inverted Papilloma: Systematic Review and Meta-Analysis. Am J Rhinol Allergy. 2018 May;32(3):167-174. doi: 10.1177/1945892418765004. Epub 2018 Apr 12.
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citation: Dayal A, Rhee JS, Garcia GJ. Impact of Middle versus Inferior Total Turbinectomy on Nasal Aerodynamics. Otolaryngol Head Neck Surg. 2016 Sep;155(3):518-25. doi: 10.1177/0194599816644915. Epub 2016 May 10.
citation: Morrissey DK, Wormald PJ, Psaltis AJ. Prelacrimal approach to the maxillary sinus. Int Forum Allergy Rhinol. 2016 Feb;6(2):214-8. doi: 10.1002/alr.21640. Epub 2015 Sep 8. No abstract available.