Endoscopic Approaches To The Maxillary Sinus: A Comparative Study

NCT ID: NCT03962413

Last Updated: 2020-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-10-01

Brief Summary

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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

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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.

Conditions

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Maxillary Sinus Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It is a prospective randomized comparative clinical study.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Endoscopic Approaches To Maxillary Sinus

Intervention Type PROCEDURE

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.

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

Group Type ACTIVE_COMPARATOR

Endoscopic Approaches To Maxillary Sinus

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

Endoscopic Approaches To Maxillary Sinus

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Shimaa Ibrahem Mohammed

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ahmed ae abdelwahab, professor

Role: STUDY_CHAIR

Assiut University

Locations

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Assiut University Hospital ,Otolaryngology department.

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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shimaa ib mohammed, assistant lecturer

Role: CONTACT

01285876066 ext. 0882146896

mohamed om gad, lecturer

Role: CONTACT

01153034442

References

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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.

Reference Type BACKGROUND
PMID: 7661800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23557558 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14599136 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23120545 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23451474 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15933514 (View on PubMed)

Other Identifiers

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Approaches To Maxillary Sinus

Identifier Type: -

Identifier Source: org_study_id

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