Extended Endoscopic Approaches to Non-malignant Maxillary Sinus Lesions Comparative

Maxillary Sinus Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05494099
• Other study ID #: maillary sinus approaches
• Status: Recruiting
• Start date: September 2022
• Est. completion date: January 2024

Study information

• Verified date: August 2022
• Source: Tanta University
• Contact: Eslam mo Shata, MSc
• Phone: 020102362407
• Email: eslam.shata13[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: January 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Approach-Approach Conflict
• Maxillary Sinus Disease
• Paranasal Sinus Diseases

Intervention

Procedure:
• endoscopic maxillary mega-antrostomy
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.
• Endoscopic Modified Medial Maxillectomy
In this approach, the maxillary sinus is operated upon, while the inferior turbinate and nasolacrimal duct are preserved.
• Modified endoscopic pre-lacrimal approach
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.

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Tanta	Gharbia Government

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (11)

Cho DY, Hwang PH. Results of endoscopic maxillary mega-antrostomy in recalcitrant maxillary sinusitis. Am J Rhinol. 2008 Nov-Dec;22(6):658-62. doi: 10.2500/ajr.2008.22.3248. — View 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. — View Citation

Gosau M, Rink D, Driemel O, Draenert FG. Maxillary sinus anatomy: a cadaveric study with clinical implications. Anat Rec (Hoboken). 2009 Mar;292(3):352-4. doi: 10.1002/ar.20859. — View 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. Review. — View Citation

Kastl KG, Rettinger G, Keck T. The impact of nasal surgery on air-conditioning of the nasal airways. Rhinology. 2009 Sep;47(3):237-41. doi: 10.4193/Rhin08.014. Review. — View Citation

Luong A, Citardi MJ, Batra PS. Management of sinonasal malignant neoplasms: defining the role of endoscopy. Am J Rhinol Allergy. 2010 Mar-Apr;24(2):150-5. doi: 10.2500/ajra.2010.24.3451. — View 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. — View Citation

Robey A, O'Brien EK, Leopold DA. Assessing current technical limitations in the small-hole endoscopic approach to the maxillary sinus. Am J Rhinol Allergy. 2010 Sep-Oct;24(5):396-401. doi: 10.2500/ajra.2010.24.3486. — View Citation

Sadeghi N, Al-Dhahri S, Manoukian JJ. Transnasal endoscopic medial maxillectomy for inverting papilloma. Laryngoscope. 2003 Apr;113(4):749-53. — View Citation

Woodworth BA, Parker RO, Schlosser RJ. Modified endoscopic medial maxillectomy for chronic maxillary sinusitis. Am J Rhinol. 2006 May-Jun;20(3):317-9. — View Citation

Wormald PJ, Ooi E, van Hasselt CA, Nair S. Endoscopic removal of sinonasal inverted papilloma including endoscopic medial maxillectomy. Laryngoscope. 2003 May;113(5):867-73. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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