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:
Condition or disease | Intervention/treatment | Phase |
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Maxillary Sinus Surgery | Procedure: Endoscopic Approaches To Maxillary Sinus | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | It is a prospective randomized comparative clinical study. |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Endoscopic Approaches To The Maxillary Sinus: A Comparative Study |
Actual Study Start Date : | October 1, 2019 |
Estimated Primary Completion Date : | September 1, 2021 |
Estimated Study Completion Date : | October 1, 2021 |
Arm | Intervention/treatment |
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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
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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. |
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: shimaa ib mohammed, assistant lecturer | 01285876066 ext 0882146896 | amerragab2020@yahoo.com | |
Contact: mohamed om gad, lecturer | 01153034442 | Mohamedomar18@yahoo.com |
Egypt | |
Assiut University Hospital ,Otolaryngology department. | Recruiting |
Assiut, Egypt |
Study Chair: | ahmed ae abdelwahab, professor | Assiut University |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 19, 2019 | ||||||||
First Posted Date ICMJE | May 24, 2019 | ||||||||
Last Update Posted Date | May 11, 2020 | ||||||||
Actual Study Start Date ICMJE | October 1, 2019 | ||||||||
Estimated Primary Completion Date | September 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
accessibility of each endoscopic approach to visualize and reach the different walls and recesses of the maxillary sinus. [ Time Frame: assessment will be intraoperative only during conduction of the operation. ] 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
Rate of recurrence [ Time Frame: 6 months ] 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.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Endoscopic Approaches To The Maxillary Sinus: A Comparative Study | ||||||||
Official Title ICMJE | Endoscopic Approaches To The Maxillary Sinus: A Comparative Study | ||||||||
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:
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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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: It is a prospective randomized comparative clinical study. Masking: Single (Participant)Primary Purpose: Treatment |
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Condition ICMJE | Maxillary Sinus Surgery | ||||||||
Intervention ICMJE | 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. |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
100 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | October 1, 2021 | ||||||||
Estimated Primary Completion Date | September 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Egypt | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03962413 | ||||||||
Other Study ID Numbers ICMJE | Approaches To Maxillary Sinus | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Shimaa Ibrahem Mohammed, Assiut University | ||||||||
Study Sponsor ICMJE | Assiut University | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Assiut University | ||||||||
Verification Date | May 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |