Extended Endoscopic Approaches to Non-malignant Maxillary Sinus Lesions Comparative

August 7, 2022 updated by: Eslam Mohamed Shata, Tanta University

Extended Endoscopic Approaches to Non-malignant Maxillary Sinus Lesions Comparative Study

The aim of this study is to compare the outcomes of endoscopic middle meatus mega-antrostomy, endoscopic pre-lacrimal recess approach and endoscopic modified medial maxillectomy 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. 4. Symptomatic relief by pre- and post-operative Sino-Nasal Outcome Test 22, Arabic translation and validation (SNOT-22) which is a reliable and valid outcome measure for CRS patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A wide range of surgical ways to reach maxillary sinus. Historically, maxillary sinus was entered by external approaches such as lateral rhinotomy etc. in benign or malignant diseases, but now endoscopic approaches have recently replaced external approaches as the standard of treatment of maxillary sinus diseases due to reduced morbidity, improved visualisation and low recurrence rates of benign tumours.

Studies found that middle meatal antrostomy only provided access to about 24-34 percent of the total sinus volume only and rarely offer access to the anterior wall and sinus floor, regardless of the angled instruments used .Endoscopic maxillary mega-antrostomy is typically used as a revision procedure in patients with maxillary sinusitis refractory to surgery. The resulting antrostomy is greatly enlarged and allows the sinus to drain more easily by gravity, as well as admitting topical therapy more readily .

Radical endoscopic medial maxillectomy is indicated for the resection of benign and malignant sinonasal neoplasms when wide surgical access and tumor clearance is required However, resection of the inferior turbinate head may contributes to nasal crusting, dryness and empty nose syndrome ,so modified endoscopic medial maxillectomy gives better access to the maxillary sinus, with preserving the head of the inferior turbinate Pre-lacrimal recess approach allows for direct access to the sinus with 0-degree endoscopes and straight instruments, and thus improved visualisation of its contents especially anterior sinus wall, better handling of tools with preservation of inferior turbinate and nasolacrimal duct It is difficult to select suitable approach to maxillary sinus to ensure proper intraoperative visualization and better access to disease with fewer complications that is why we do this study.

Study Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Gharbia Government
      • Tanta, Gharbia Government, Egypt
        • Recruiting
        • Faculty of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic rhinosinusitis who not respond to medical treatment and are planned to be operated by endoscopic sinus surgery.

Description

Inclusion Criteria:

  • Inflammatory disease of the maxillary sinus in the context of allergic or infective rhinosinusitis, with or without formation of inflammatory polyps. When such cases fail to respond to maximal medical therapy.
  • Benign and locally malignant neoplasms of the maxillary sinus (ex: inverted papilloma) which are planned to be removed by extended endoscopic approach.

Exclusion Criteria:

  • Patients who are unfit to surgery (ex: with bleeding disorders or severe systemic diseases).
  • Patients who refuse surgery or difficult to be followed up.
  • Patients with minimal lesions who respond to medical treatment.
  • Patients with malignant tumor of maxillary sinus proved by histopathology.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A (1st 25 patients)
The middle meatal mega-antrostomy approach.
Procedure: endoscopic maxillary mega-antrostomy
a mucosal sparing technique that facilitates mucus clearance and sinus irrigation in terminally dysfunctional maxillary sinuses. EMMA involves extending the antrostomy through the posterior half of the inferior turbinate down to the floor of the nose, creating a significantly enlarged antrostomy.
Group B (2nd 25 patients)
The endoscopic modified medial maxillectomy approach.
Procedure: Endoscopic Modified Medial Maxillectomy
In this approach, the maxillary sinus is operated upon, while the inferior turbinate and nasolacrimal duct are preserved.
Group C (3rd 25 patients)
The endoscopic prelacrimal recess approach.
Procedure: Modified endoscopic pre-lacrimal approach
The approach involves making a curved mucosal incision on the lateral nasal wall just anterior to the head of the inferior turbinate. The nasal mucosa was then undermined off the lateral nasal wall. The maxillary sinus was entered with a chisel, and the medial bony wall of the maxillary sinus removed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-operative Endoscopic Assesment
Time Frame: Intraoperative only
Assessment of the accessibility of endoscopic approach which will be evaluated by using different types of telescopes to visualize and reach the different walls and recesses of the maxillary sinus
Intraoperative only

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sino-Nasal Outcome Test 22,. Arabic translation and validation (SNOT-22)
Time Frame: 3 months

Assess the effect of each endoscopic approach on recurrence rate of maxillary sinus lesions.

regular endoscopic examination first visit after one week, second after 3 weeks and the third after 3 months.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Study Director: Hassan Mu Hegazy, MD, Tanta University Hospital, Egypt.
  • Study Director: Ahmed Mo Gamea, MD, Tanta University Hospital, Egypt.
  • Study Director: Mohamed Os Tomom, MD, Tanta University Hospital, Egypt.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

August 7, 2022

First Submitted That Met QC Criteria

August 7, 2022

First Posted (Actual)

August 9, 2022

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 7, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • maillary sinus approaches

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

To compare the outcomes of endoscopic middle meatus mega-antrostomy, endoscopic pre-lacrimal recess approach and endoscopic modified medial maxillectomy 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. 4. Symptomatic relief by pre- and post-operative SNOT-22 which is a reliable and valid outcome measure for CRS patients.

IPD Sharing Time Frame

1 year

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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