Endoscopic Frontal Sinus SurgeryNCT05979662
Endoscopic Frontal Sinus Surgery Draf III in Moderate to Severe Eosinophilic Chronic Rhinosinusitis With Polyps
A study testing Endoscopic frontal sinus surgery grade 6(Draf III). and Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa) in people with Endoscopic Frontal Sinus Surgery and Chronic Rhinosinusitis With Nasal Polyps, run by Ibrahim Talal Elshamy at 2 sites in Egypt.
Trial summary
The aim of this study is to evaluate the effect of the primary endoscopic frontal sinus surgery on the clinical outcome in patients having moderate to severe eosinophilic chronic rhinosinusitis with polyps with primary outcome measures in form of recurrence of polyp using endoscopic polyp score and Secondary outcome… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Frontal Sinus Surgery, Chronic Rhinosinusitis With Nasal Polyps, Draf III
- What is being tested?
- Endoscopic frontal sinus surgery grade 6(Draf III). and Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2021to 30 Sep 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with moderate or severe eosinophilic chronic rhinosinusitis with polyps who failed appropriate medical treatment in the form of antibiotic, systemic and local corticosteroid for 3 months .
Who cannot join
- Narrow anteroposterior diameter of frontal sinus ostium(1cm or less)
- Patients showing less or highest degree of radiological complexity of surgery on studying the Computed Tomography.
- Any contraindication for general anesthesia.
- Patients below age of 18 years.
- Incomplete follow up
- previous sinus surgery
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Tanta University Hospitals
Tanta, El-Gharbia, 31511
Ibrahim T Elshamy, +201022373920, hematalal93@gmail.com
Mohammed H Hamad, Prof
- Recruiting
Tanta University
Tanta, El-Gharbia, 31511
Ibrahim T Elshamy, +201022373920, hematalal93@gmail.com
Mohammed H Hamad, Prof
About this study
Official title: Clinical Evaluation of Primary Endoscopic Frontal Sinus Surgery Grade 6 (Draf III) in Patients With Moderate to Severe Eosinophilic Chronic Rhinosinusitis With Polyps
The aim of this study is to evaluate the effect of the primary endoscopic frontal sinus surgery on the clinical outcome in patients having moderate to severe eosinophilic chronic rhinosinusitis with polyps with primary outcome measures in form of recurrence of polyp using endoscopic polyp score and Secondary outcome measures include Lund MacKay score, SNOT-22 and need for corticosteroid to control polyp postoperatively.
Read the detailed description
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a common inflammatory disorder, affecting about 4% of the population worldwide and strongly impacts the quality of life of affected patient.
Eosinophilic chronic rhinosinusitis (ECRS) is a subtype of recalcitrant Chronic rhinosinusitis . Patients with ECRS and generally having a tissue eosinophil >10 cells per high power field (HPF), have worse disease severity and poorer treatment outcomes compared to non-Eosinophilic chronic rhinosinusitis.
- Conditions
- Endoscopic Frontal Sinus Surgery, Chronic Rhinosinusitis With Nasal Polyps, Draf III, Draf I or IIa
- Being tested
- Endoscopic frontal sinus surgery grade 6(Draf III)., Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic frontal sinus surgery grade 6(Draf III).Procedure or surgery
Patients will receive endoscopic frontal sinus surgery grade 6(Draf III).
Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa)Procedure or surgery
Patients will receive endoscopic frontal sinus surgery grade 1-3(Draf I or IIa).
| Study group | Role | What they receive |
|---|---|---|
| Group one | Experimental | Patients will undergo endoscopic frontal sinus surgery grade 6(Draf III). Receives: Procedure: Endoscopic frontal sinus surgery grade 6(Draf III). |
| Group two | Active comparator | Patients will undergo endoscopic frontal sinus surgery grade 1-3(Draf I or IIa). Receives: Procedure: Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of polyp using endoscopic polyp score
Polyps were evaluated on each side through nasal endoscopy at each visit and graded based on polyp size, resulting in scores of 0 to 4 9. Zero is no polyp, 1 = small polyps in the middle meatus not reaching below the inferior border of the middle turbinate, 2 = polyps reaching below the lower border of the middle turbinate, 3 = large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate, and 4 = large polyps causing complete obstruction of the inferior nasal cavity. The sum of the left and right nostril scores is the Nasal Polyp Score
Measured: One year postoperatively
Secondary outcomes (2)
Lund MacKay score
The Lund-Mackay staging system scores each sinus (anterior ethmoid, posterior ethmoid, maxillary, frontal, and sphenoid sinuses) according to the following scale: 0 (no opacification), 1 (partial opacification), or 2 (complete opacification).
Measured: One year postoperatively
Sinonasal Outcome Test- 22
SNOT- 22 was measured based on a 0-5 scale, where 0 defines no problems with the given symptom and 5 defines maximal problems
Measured: One year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Jan 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Frontal Sinus SurgeryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ibrahim Talal Elshamy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ibrahim Talal Elshamy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979662
- Sponsor's protocol ID
- 34417/1/21
- Status last verified
- Jul 2023
- First submitted
- 29 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Primary Endoscopic Frontal Sinus Surgery Grade 6 (Draf III) in Patients With Moderate to Severe Eosinophilic Chronic Rhinosinusitis With Polyps
- ClinicalTrials.gov ID
- NCT05979662
- Acronym / sponsor ID
- 34417/1/21
- Conditions
- Endoscopic Frontal Sinus Surgery, Chronic Rhinosinusitis With Nasal Polyps, Draf III, Draf I or IIa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ibrahim Talal ElshamyUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 7 Aug 2023 (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 evaluate the effect of the primary endoscopic frontal sinus surgery on the clinical outcome in patients having moderate to severe eosinophilic chronic rhinosinusitis with polyps with primary outcome measures in form of recurrence of polyp using endoscopic polyp score and Secondary outcome measures include Lund MacKay score, SNOT-22 and need for corticosteroid to control polyp postoperatively.
Detailed description
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a common inflammatory disorder, affecting about 4% of the population worldwide and strongly impacts the quality of life of affected patient.
Eosinophilic chronic rhinosinusitis (ECRS) is a subtype of recalcitrant Chronic rhinosinusitis . Patients with ECRS and generally having a tissue eosinophil >10 cells per high power field (HPF), have worse disease severity and poorer treatment outcomes compared to non-Eosinophilic chronic rhinosinusitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group one | Experimental | Procedure: Endoscopic frontal sinus surgery grade 6(Draf III).Patients will undergo endoscopic frontal sinus surgery grade 6(Draf III). |
| Group two | Active comparator | Procedure: Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa)Patients will undergo endoscopic frontal sinus surgery grade 1-3(Draf I or IIa). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with moderate or severe eosinophilic chronic rhinosinusitis with polyps who failed appropriate medical treatment in the form of antibiotic, systemic and local corticosteroid for 3 months .
Key exclusion criteria (6 listed)
- Narrow anteroposterior diameter of frontal sinus ostium(1cm or less)
- Patients showing less or highest degree of radiological complexity of surgery on studying the Computed Tomography.
- Any contraindication for general anesthesia.
- Patients below age of 18 years.
- Incomplete follow up
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 frontal sinus surgery grade 6(Draf III).Patients will receive endoscopic frontal sinus surgery grade 6(Draf III). | Procedure or surgery | Group one |
| Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa)Patients will receive endoscopic frontal sinus surgery grade 1-3(Draf I or IIa). | Procedure or surgery | Group two |
Primary outcome
Recurrence of polyp using endoscopic polyp score
Time frame: One year postoperatively
Polyps were evaluated on each side through nasal endoscopy at each visit and graded based on polyp size, resulting in scores of 0 to 4 9. Zero is no polyp, 1 = small polyps in the middle meatus not reaching below the inferior border of the middle turbinate, 2 = polyps reaching below the lower border of the middle turbinate, 3 = large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate, and 4 = large polyps causing complete obstruction of the inferior nasal cavity. The sum of the left and right nostril scores is the Nasal Polyp Score
2 secondary outcomes
Lund MacKay score
Time frame: One year postoperatively
Sinonasal Outcome Test- 22
Time frame: One year postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Endoscopic Frontal Sinus Surgery
Not yet recruiting
Endoscopic Direct "Draf IIa" (Carolyn's Window Approach) Versus Endoscopic Angled "Draf IIa"Approach in Chronic Rhinosinusitis With Frontal Sinus Affection ( A Comparative Study ).
Chronic Rhinosinusitis (CRS), Frontal Sinusitis
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic frontal sinus surgery grade 6(Draf III). and Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa) in people with Endoscopic Frontal Sinus Surgery and Chronic Rhinosinusitis With Nasal Polyps, run by Ibrahim Talal Elshamy at 2 sites 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 1 inclusion and 6 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 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Ibrahim T Elshamy, MSc (+20 102 237 3920, hematalal93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of polyp using endoscopic polyp score (time frame: One year postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2023.