Endoscopic Approaches To The Maxillary Sinus: A Comparative Study

The aim of this study is to compare the outcomes of endoscopic pre lacrimal recess approach, canine fossa approach and middle meatal antrostomy approach 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 or by MSCT scan.

Study Overview

• Status: Unknown
• Conditions: Maxillary Sinus Surgery
• Intervention / Treatment: Procedure: Endoscopic Approaches To Maxillary Sinus

Detailed Description

The maxillary sinus is the sinus most commonly affected by disease.. It varies greatly in size, shape, position and pneumatisation, not only in different individuals, but also in different sides of the same individual .

A broad spectrum of disease processes can involve the maxillary sinus, such as infective, odontogenic and neoplastic. In simple cases, a standard uncinectomy and middle meatal antrostomy may be sufficient for visualisation and clearance of disease but despite this a drawback still exists in both external and intranasal surgical procedures. Compromise of the inferior turbinate (IT) and nasolacrimal duct (NLD) is often unavoidable .

According to the anatomy of MS and the feature of diseases originated from MS assessed with multi-angulated telescopes, including 30 ,45 and 70 telescopes, with kinds of curved instruments, there are still some areas which can not be viewed and handled . Such critical areas as the inferior, lateral, anterior wall, zygomatic recess, alveolar recess and prelacrimal recess of maxillary sinus are difficult to approach. For this reason other approaches are needed like canine fossa approach (CFA), prelacrimal recess approach (PLRA) and medial maxillectomy approach.

Review of the literature revealed no meta-analysis or evidence based medicine comparing different endoscopic approaches to maxillary sinus regarding feasibility of the access to different recesses and residual lesions.

The endonasal endoscopic prelacrimal recess approach (PLRA) provides a clear view through wide access to all walls of the maxillary sinus while still preserving the nasolacrimal duct and inferior turbinate.

It enables us to accurately, mini-invade and completely remove MS lesions. It is a physiological and functional surgery, and has great advantages in treating the diseases of the nasal cavity.

Canine fossa approach (CFA) has been proposed as an alternative method of obtaining access to the maxillary antrum. Although a few studies have demonstrated the benefits of CFA in management of the severely diseased maxillary sinus, the efficacy and superiority of this method compared with conventional MMA require further investigation above all considering new microdebrider blades that can be inserted through the antrostomy.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: shimaa ib mohammed, assistant lecturer; Phone Number: 0882146896 01285876066; Email: amerragab2020@yahoo.com
• Study Contact Backup: Name: mohamed om gad, lecturer; Phone Number: 01153034442; Email: Mohamedomar18@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Assiut University Hospital ,Otolaryngology department.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age more than 18 years,
• Incidence of extensive denovo or recurrent sinonasal polyposis,
• Denovo or recurrent cases of antrochoanal polyp,
• Incidence of both denovo or recurrent allergic fungal rhinosinusitis,
• Maxillary sinus cysts and mucocoel,
• Presence of MS tumours such as inverted papilloma
• Presence of vascular tumours,
• Presence of sinonasal malignancies extending to the maxillary sinus,
• Having no contraindications for surgery under general anaesthesia.

Exclusion Criteria:

• Age less than 18 years,
• Refusal of the patient,
• Having contraindications for surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The middle meatal antrostomy approach.; The middle turbinate will be gently moved medially. Then uncinectomy is the next step which will be performed in numerous ways. Once the natural ostium will be identified, an ostium seeker will be placed through the ostium and then carefully will be pushed posteriorly to widen the ostium. Using a through-cutting forceps, the ostium will be enlarged.	Procedure: Endoscopic Approaches To Maxillary Sinus; The first group (group A): The middle meatal antrostomy approach. The second group (group B): The endoscopic prelacrimal recess approach The third group (group c): The canine fossa approach.
Active Comparator: The endoscopic prelacrimal recess approach; A curved incision will be made between the anterior aspect of the IT and the posterior end of the nasal vestibule.the mucoperiosteum will be lifted posteriorly.Bone removal will be achieved. the anterior bony portion of the medial wall of the MS will be removed, .then the IT-NLD flap will be formed.The prelacrimal recess will be opened	Procedure: Endoscopic Approaches To Maxillary Sinus; The first group (group A): The middle meatal antrostomy approach. The second group (group B): The endoscopic prelacrimal recess approach The third group (group c): The canine fossa approach.
Active Comparator: The canine fossa approach.; It will be done either transnasally or transorally: ** The transoral approach through a sublabial incision : CFA consist in a trocar placed in the canine fossa.After removal of the trocar a 4-mm microdebrider blade will be placed through the passage created by the trocar. ** The transnasal approach: A curved incision will be made between the anterior aspect of the Inferior Turbinate and the posterior end of the nasal vestibule,the mucoperiosteum will be lifted posteriorly Then the investigators will reach the anterior wall of the maxillary sinus through bone removal which will be achieved using a gauch and hammer and a high-speed electric drill.	Procedure: Endoscopic Approaches To Maxillary Sinus; The first group (group A): The middle meatal antrostomy approach. The second group (group B): The endoscopic prelacrimal recess approach The third group (group c): The canine fossa approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
accessibility of each endoscopic approach to visualize and reach the different walls and recesses of the maxillary sinus.	assessment of the accessibility and feasibility of endoscopic pre lacrimal recess approach, canine fossa approach and middle meatal antrostomy approach which will be evaluated clinically by the surgeon intraoperatively by using different types of telescopes either 0 degree telescope or multi-angulated telescopes including 30 ,45 and 70 telescopes to visualize and reach the different walls and recesses of the maxillary sinus during treatment of maxillary sinus lesions.	assessment will be intraoperative only during conduction of the operation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of recurrence	to assess the effect of each endoscopic approach on recurrence rate of maxillary sinus lesions. recurrence will be evaluated by clinical endoscopic evaluation of regular endoscopic examination first visit after one week, the second after 3 weeks and the third after 3 months. MSCT nose and paranasal sinuses will be done at the end of 6 month.	6 months

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: ahmed ae abdelwahab, professor, Assiut University

Publications and helpful links

General Publications

• Low WK. Complications of the Caldwell-Luc operation and how to avoid them. Aust N Z J Surg. 1995 Aug;65(8):582-4. doi: 10.1111/j.1445-2197.1995.tb01700.x.
• Zhou B, Han DM, Cui SJ, Huang Q, Wang CS. Intranasal endoscopic prelacrimal recess approach to maxillary sinus. Chin Med J (Engl). 2013 Apr;126(7):1276-80.
• Hosemann W, Scotti O, Bentzien S. Evaluation of telescopes and forceps for endoscopic transnasal surgery on the maxillary sinus. Am J Rhinol. 2003 Sep-Oct;17(5):311-6.
• Anand V, Santosh S, Aishwarya A. Canine fossa approaches in endoscopic sinus surgery - our experience. Indian J Otolaryngol Head Neck Surg. 2008 Sep;60(3):214-7. doi: 10.1007/s12070-008-0080-3. Epub 2008 Oct 22.
• Chen Y, Zhang H, Ge P, Wei T, Luo X, Huang P. [Combined middle meatus and expand pre-lacrimal recess-maxillary sinus approach for endoscopic maxillary sinus surgery]. Lin Chung Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2012 Dec;26(23):1070-2, 1076. Chinese.
• Sathananthar S, Nagaonkar S, Paleri V, Le T, Robinson S, Wormald PJ. Canine fossa puncture and clearance of the maxillary sinus for the severely diseased maxillary sinus. Laryngoscope. 2005 Jun;115(6):1026-9. doi: 10.1097/01.MLG.0000162651.22019.4A.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: May 19, 2019
• First Submitted That Met QC Criteria: May 23, 2019
• First Posted (Actual): May 24, 2019

Study Record Updates

• Last Update Posted (Actual): May 11, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Endoscopic Approaches To Maxillary Sinus
• Other Study ID Numbers: Approaches To Maxillary Sinus

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No