Extended Endoscopic Approaches to Non-malignant Maxillary Sinus Lesions Comparative
NCT ID: NCT05494099
Last Updated: 2022-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
75 participants
OBSERVATIONAL
2022-09-30
2024-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Endoscopic Approaches To The Maxillary Sinus: A Comparative Study
NCT03962413
Nasal Anatomical and Pathological Variants in Patients With Antrochoanal Polyps
NCT05989919
Isolated Maxillary Sinus Lesions in Sohag University Hospital
NCT06556225
Retrospective Study for Recurrent Nasal Polyposis
NCT04804488
Results of Endoscopic Sinus Surgery in Management of Ophthalmological Complications of Chronic Rhino Sinusitis
NCT04617223
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A (1st 25 patients)
The middle meatal mega-antrostomy approach.
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.
Group B (2nd 25 patients)
The endoscopic modified medial maxillectomy approach.
Endoscopic Modified Medial Maxillectomy
In this approach, the maxillary sinus is operated upon, while the inferior turbinate and nasolacrimal duct are preserved.
Group C (3rd 25 patients)
The endoscopic prelacrimal recess approach.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tanta University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Eslam Mohamed Shata
doctor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hassan Mu Hegazy, MD
Role: STUDY_DIRECTOR
Tanta University Hospital, Egypt.
Ahmed Mo Gamea, MD
Role: STUDY_DIRECTOR
Tanta University Hospital, Egypt.
Mohamed Os Tomom, MD
Role: STUDY_DIRECTOR
Tanta University Hospital, Egypt.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of medicine
Tanta, Gharbia Government, Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Woodworth BA, Parker RO, Schlosser RJ. Modified endoscopic medial maxillectomy for chronic maxillary sinusitis. Am J Rhinol. 2006 May-Jun;20(3):317-9. doi: 10.2500/ajr.2006.20.2850.
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.
Sadeghi N, Al-Dhahri S, Manoukian JJ. Transnasal endoscopic medial maxillectomy for inverting papilloma. Laryngoscope. 2003 Apr;113(4):749-53. doi: 10.1097/00005537-200304000-00031.
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. doi: 10.1097/00005537-200305000-00017.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
maillary sinus approaches
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.