Extended Endoscopic Approaches to Non-malignant Maxillary Sinus Lesions Comparative

NCT05494099 | Unknown

• 1 other identifier: maillary sinus approaches
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Maxillary Sinus Disease; Approach-Approach Conflict

Keywords

maxillary sinus; endoscopic approaches

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sino-Nasal Outcome Test 22,. Arabic translation and validation (SNOT-22)

  3 months

Study Arms (3)

Group A (1st 25 patients)

The middle meatal mega-antrostomy approach.

Procedure: endoscopic maxillary mega-antrostomy

Group B (2nd 25 patients)

The endoscopic modified medial maxillectomy approach.

Procedure: Endoscopic Modified Medial Maxillectomy

Group C (3rd 25 patients)

The endoscopic prelacrimal recess approach.

Procedure: Modified endoscopic pre-lacrimal approach

Interventions

endoscopic maxillary mega-antrostomy PROCEDURE

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 A (1st 25 patients)

Endoscopic Modified Medial Maxillectomy PROCEDURE

In this approach, the maxillary sinus is operated upon, while the inferior turbinate and nasolacrimal duct are preserved.

Group B (2nd 25 patients)

Modified endoscopic pre-lacrimal approach PROCEDURE

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.

Group C (3rd 25 patients)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of medicine

Tanta, Gharbia Government, Egypt

RECRUITING

Related Publications (11)

• 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.

  PMID: 29649889 BACKGROUND

• 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.

  PMID: 21244743 BACKGROUND

• 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.

  PMID: 19178809 BACKGROUND

• 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.

  PMID: 16871936 BACKGROUND

• 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.

  PMID: 19248167 BACKGROUND

• 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.

  PMID: 12671441 BACKGROUND

• 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.

  PMID: 12792324 BACKGROUND

• 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.

  PMID: 20338116 BACKGROUND

• 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.

  PMID: 19839243 BACKGROUND

• 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.

  PMID: 27165673 BACKGROUND

• 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.

  PMID: 26346189 BACKGROUND

Study Officials

• Hassan Mu Hegazy, MD

  Tanta University Hospital, Egypt.

  STUDY DIRECTOR

• Ahmed Mo Gamea, MD

  Tanta University Hospital, Egypt.

  STUDY DIRECTOR

• Mohamed Os Tomom, MD

  Tanta University Hospital, Egypt.

  STUDY DIRECTOR

Central Study Contacts

Eslam mo Shata, MSc

CONTACT

020102362407; eslam.shata13@gmail.com

Mohamed Ha Askar, MD

CONTACT

0201227744576; mohamed_askar@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 9, 2022
• Study Start: September 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: January 1, 2024
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 year

Locations

EG (1)