Endoscopic Approaches To The Maxillary Sinus: A Comparative Study

Maxillary Sinus Surgery Clinical Trial

Official title:

Endoscopic Approaches To The Maxillary Sinus: A Comparative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03962413
• Other study ID #: Approaches To Maxillary Sinus
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: shimaa ib mohammed, assistant lecturer
• Phone: 01285876066
• Email: amerragab2020[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Maxillary Sinus Surgery

Intervention

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.

Locations

Country	Name	City	State
Egypt	Assiut University Hospital ,Otolaryngology department.	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (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. — View Citation

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. — View Citation

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. — View Citation

Low WK. Complications of the Caldwell-Luc operation and how to avoid them. Aust N Z J Surg. 1995 Aug;65(8):582-4. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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