Clinical trial NCT03962413: Endoscopic Approaches To The Maxillary Sinus: A Comparative Study
Official title: Endoscopic Approaches To The Maxillary Sinus: A Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maxillary Sinus Surgery
Keywords: Endoscopic Approaches To Maxillary Sinus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a prospective randomized comparative clinical study.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: accessibility of each endoscopic approach to visualize and reach the different walls and recesses of the maxillary sinus.
timeFrame: assessment will be intraoperative only during conduction of the operation.
Secondary outcomes:
measure: Rate of recurrence
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital ,Otolaryngology department.
Study officials:
affiliation: Assiut University
name: ahmed ae abdelwahab, professor
role: STUDY_CHAIR
References:
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citation: 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.
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 Chuang Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2012 Dec;26(23):1070-2, 1076. Chinese.
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. doi: 10.1097/01.MLG.0000162651.22019.4A.