Maxillary Sinus DiseaseNCT05494099
Extended Endoscopic Approaches to Non-malignant Maxillary Sinus Lesions Comparative
An observational study of Maxillary Sinus Disease and Approach-Approach Conflict, run by Tanta University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Maxillary Sinus Disease, Approach-Approach Conflict
- What is being tested?
- endoscopic maxillary mega-antrostomy, Endoscopic Modified Medial Maxillectomy and Modified endoscopic pre-lacrimal approach
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2022to Jan 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with chronic rhinosinusitis who not respond to medical treatment and are planned to be operated by endoscopic sinus surgery.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine
Tanta, Gharbia Government
Eslam Mo Shata, Msc, 0201092362407, eslam.shata13@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- endoscopic maxillary mega-antrostomy, Endoscopic Modified Medial Maxillectomy, Modified endoscopic pre-lacrimal approach
- Keywords
- maxillary sinus, endoscopic approaches
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic maxillary mega-antrostomyProcedure or surgery
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.
Endoscopic Modified Medial MaxillectomyProcedure or surgery
In this approach, the maxillary sinus is operated upon, while the inferior turbinate and nasolacrimal duct are preserved.
Modified endoscopic pre-lacrimal approachProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (1st 25 patients) | The middle meatal mega-antrostomy approach. Receives: Procedure: endoscopic maxillary mega-antrostomy | |
| Group B (2nd 25 patients) | The endoscopic modified medial maxillectomy approach. Receives: Procedure: Endoscopic Modified Medial Maxillectomy | |
| Group C (3rd 25 patients) | The endoscopic prelacrimal recess approach. Receives: Procedure: Modified endoscopic pre-lacrimal approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative Endoscopic Assesment
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
Measured: Intraoperative only
Secondary outcomes (1)
Sino-Nasal Outcome Test 22,. Arabic translation and validation (SNOT-22)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study startSep 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Maxillary Sinus DiseaseStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eslam Mohamed Shata, Tanta University
- Investigators
- Hassan Mu Hegazy, MD, Study director, Tanta University Hospital, Egypt.Ahmed Mo Gamea, MD, Study director, Tanta University Hospital, Egypt.Mohamed Os Tomom, MD, Study director, Tanta University Hospital, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494099
- Sponsor's protocol ID
- maillary sinus approaches
- Status last verified
- Aug 2022
- First submitted
- 7 Aug 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Goudakos JK, Blioskas S, Nikolaou A, Vlachtsis K, Karkos P, Markou KD. Endoscopic Resection of Sinonasal Inverted Papilloma: Systematic Review and Meta-Analysis. Am J Rhinol Allergy. 2018 May;32(3):167-174. doi: 10.1177/1945892418765004. Epub 2018 Apr 12.
PubMed 29649889Robey A, O'Brien EK, Leopold DA. Assessing current technical limitations in the small-hole endoscopic approach to the maxillary sinus. Am J Rhinol Allergy. 2010 Sep-Oct;24(5):396-401. doi: 10.2500/ajra.2010.24.3486.
PubMed 21244743Cho DY, Hwang PH. Results of endoscopic maxillary mega-antrostomy in recalcitrant maxillary sinusitis. Am J Rhinol. 2008 Nov-Dec;22(6):658-62. doi: 10.2500/ajr.2008.22.3248.
PubMed 19178809Woodworth BA, Parker RO, Schlosser RJ. Modified endoscopic medial maxillectomy for chronic maxillary sinusitis. Am J Rhinol. 2006 May-Jun;20(3):317-9. doi: 10.2500/ajr.2006.20.2850.
PubMed 16871936Gosau M, Rink D, Driemel O, Draenert FG. Maxillary sinus anatomy: a cadaveric study with clinical implications. Anat Rec (Hoboken). 2009 Mar;292(3):352-4. doi: 10.1002/ar.20859.
PubMed 19248167Sadeghi N, Al-Dhahri S, Manoukian JJ. Transnasal endoscopic medial maxillectomy for inverting papilloma. Laryngoscope. 2003 Apr;113(4):749-53. doi: 10.1097/00005537-200304000-00031.
PubMed 12671441Wormald PJ, Ooi E, van Hasselt CA, Nair S. Endoscopic removal of sinonasal inverted papilloma including endoscopic medial maxillectomy. Laryngoscope. 2003 May;113(5):867-73. doi: 10.1097/00005537-200305000-00017.
PubMed 12792324Luong A, Citardi MJ, Batra PS. Management of sinonasal malignant neoplasms: defining the role of endoscopy. Am J Rhinol Allergy. 2010 Mar-Apr;24(2):150-5. doi: 10.2500/ajra.2010.24.3451.
PubMed 20338116Kastl KG, Rettinger G, Keck T. The impact of nasal surgery on air-conditioning of the nasal airways. Rhinology. 2009 Sep;47(3):237-41. doi: 10.4193/Rhin08.014.
PubMed 19839243Dayal A, Rhee JS, Garcia GJ. Impact of Middle versus Inferior Total Turbinectomy on Nasal Aerodynamics. Otolaryngol Head Neck Surg. 2016 Sep;155(3):518-25. doi: 10.1177/0194599816644915. Epub 2016 May 10.
PubMed 27165673Morrissey DK, Wormald PJ, Psaltis AJ. Prelacrimal approach to the maxillary sinus. Int Forum Allergy Rhinol. 2016 Feb;6(2):214-8. doi: 10.1002/alr.21640. Epub 2015 Sep 8. No abstract available.
PubMed 26346189
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Endoscopic Approaches to Non-malignant Maxillary Sinus Lesions Comparative Study
- ClinicalTrials.gov ID
- NCT05494099
- Acronym / sponsor ID
- maillary sinus approaches
- Keywords
- maxillary sinus, endoscopic approaches
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (1st 25 patients) | – | Procedure: endoscopic maxillary mega-antrostomyThe middle meatal mega-antrostomy approach. |
| Group B (2nd 25 patients) | – | Procedure: Endoscopic Modified Medial MaxillectomyThe endoscopic modified medial maxillectomy approach. |
| Group C (3rd 25 patients) | – | Procedure: Modified endoscopic pre-lacrimal approachThe endoscopic prelacrimal recess approach. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic rhinosinusitis who not respond to medical treatment and are planned to be operated by endoscopic sinus surgery.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic maxillary mega-antrostomya 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. | Procedure or surgery | Group A (1st 25 patients) |
| Endoscopic Modified Medial MaxillectomyIn this approach, the maxillary sinus is operated upon, while the inferior turbinate and nasolacrimal duct are preserved. | Procedure or surgery | Group B (2nd 25 patients) |
| Modified endoscopic pre-lacrimal approachThe 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. | Procedure or surgery | Group C (3rd 25 patients) |
Primary outcome
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
1 secondary outcome
Sino-Nasal Outcome Test 22,. Arabic translation and validation (SNOT-22)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Background: PubMed 29649889Goudakos JK, Blioskas S, Nikolaou A, Vlachtsis K, Karkos P, Markou KD. Endoscopic Resection of Sinonasal Inverted Papilloma: Systematic Review and Meta-Analysis. Am J Rhinol Allergy. 2018 May;32(3):167-174. doi: 10.1177/1945892418765004. Epub 2018 Apr 12.
- Background: PubMed 21244743Robey A, O'Brien EK, Leopold DA. Assessing current technical limitations in the small-hole endoscopic approach to the maxillary sinus. Am J Rhinol Allergy. 2010 Sep-Oct;24(5):396-401. doi: 10.2500/ajra.2010.24.3486.
- Background: PubMed 19178809Cho DY, Hwang PH. Results of endoscopic maxillary mega-antrostomy in recalcitrant maxillary sinusitis. Am J Rhinol. 2008 Nov-Dec;22(6):658-62. doi: 10.2500/ajr.2008.22.3248.
- Background: PubMed 16871936Woodworth BA, Parker RO, Schlosser RJ. Modified endoscopic medial maxillectomy for chronic maxillary sinusitis. Am J Rhinol. 2006 May-Jun;20(3):317-9. doi: 10.2500/ajr.2006.20.2850.
- Background: PubMed 19248167Gosau M, Rink D, Driemel O, Draenert FG. Maxillary sinus anatomy: a cadaveric study with clinical implications. Anat Rec (Hoboken). 2009 Mar;292(3):352-4. doi: 10.1002/ar.20859.
- Background: PubMed 12671441Sadeghi N, Al-Dhahri S, Manoukian JJ. Transnasal endoscopic medial maxillectomy for inverting papilloma. Laryngoscope. 2003 Apr;113(4):749-53. doi: 10.1097/00005537-200304000-00031.
- Background: PubMed 12792324Wormald PJ, Ooi E, van Hasselt CA, Nair S. Endoscopic removal of sinonasal inverted papilloma including endoscopic medial maxillectomy. Laryngoscope. 2003 May;113(5):867-73. doi: 10.1097/00005537-200305000-00017.
- Background: PubMed 20338116Luong A, Citardi MJ, Batra PS. Management of sinonasal malignant neoplasms: defining the role of endoscopy. Am J Rhinol Allergy. 2010 Mar-Apr;24(2):150-5. doi: 10.2500/ajra.2010.24.3451.
- Background: PubMed 19839243Kastl KG, Rettinger G, Keck T. The impact of nasal surgery on air-conditioning of the nasal airways. Rhinology. 2009 Sep;47(3):237-41. doi: 10.4193/Rhin08.014.
- Background: PubMed 27165673Dayal A, Rhee JS, Garcia GJ. Impact of Middle versus Inferior Total Turbinectomy on Nasal Aerodynamics. Otolaryngol Head Neck Surg. 2016 Sep;155(3):518-25. doi: 10.1177/0194599816644915. Epub 2016 May 10.
- Background: PubMed 26346189Morrissey DK, Wormald PJ, Psaltis AJ. Prelacrimal approach to the maxillary sinus. Int Forum Allergy Rhinol. 2016 Feb;6(2):214-8. doi: 10.1002/alr.21640. Epub 2015 Sep 8. No abstract available.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Mu Hegazy, MD study director
Tanta University Hospital, Egypt.
Ahmed Mo Gamea, MD study director
Tanta University Hospital, Egypt.
Mohamed Os Tomom, MD study director
Tanta University Hospital, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillary Sinus Disease and Approach-Approach Conflict, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eslam mo Shata, MSc (020102362407, eslam.shata13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-operative Endoscopic Assesment (time frame: Intraoperative only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05494099, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.