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出境医 / 临床实验 / Endoscopic Approaches To The Maxillary Sinus: A Comparative Study

Endoscopic Approaches To The Maxillary Sinus: A Comparative Study

Study Description
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.

Condition or disease Intervention/treatment Phase
Maxillary Sinus Surgery Procedure: Endoscopic Approaches To Maxillary Sinus Not Applicable

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 Design
Layout table for study information
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
Arms and Interventions
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.


Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: shimaa ib mohammed, assistant lecturer 01285876066 ext 0882146896 amerragab2020@yahoo.com
Contact: mohamed om gad, lecturer 01153034442 Mohamedomar18@yahoo.com

Locations
Layout table for location information
Egypt
Assiut University Hospital ,Otolaryngology department. Recruiting
Assiut, Egypt
Sponsors and Collaborators
Assiut University
Investigators
Layout table for investigator information
Study Chair: ahmed ae abdelwahab, professor Assiut University
Tracking Information
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
 (submitted: May 23, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
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.
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:

  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.

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
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.

Study Arms  ICMJE
  • 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.

    Intervention: Procedure: Endoscopic Approaches To Maxillary Sinus
  • 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
    Intervention: Procedure: Endoscopic Approaches To Maxillary Sinus
  • 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.

    Intervention: Procedure: Endoscopic Approaches To Maxillary Sinus
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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2019)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: shimaa ib mohammed, assistant lecturer 01285876066 ext 0882146896 amerragab2020@yahoo.com
Contact: mohamed om gad, lecturer 01153034442 Mohamedomar18@yahoo.com
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shimaa Ibrahem Mohammed, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: ahmed ae abdelwahab, professor Assiut University
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