Chronic Rhinosinusitis (CRS)NCT06668844
Endoscopic Direct "Draf IIa" (Carolyn's Window Approach) Versus Endoscopic Angled "Draf IIa"Approach in Chronic Rhinosinusitis With Frontal Sinus Affection ( A Comparative Study ).
A study testing Endoscopic direct Draf IIa and Endoscopic angled Draf IIa in people with Chronic Rhinosinusitis (CRS) and Frontal Sinusitis, run by Assiut University.
Trial summary
Patients with chronic rhinosinusitis with frontal sinus affection indicated for sinuscopy will be randomly categorized in 2 groups: group A will have endoscopic directDraf IIa frontal sinusotomy and group B will have endoscopic angled Draf IIa frontal sinusotomy, the two groups will be compared according to ostium… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Rhinosinusitis (CRS), Frontal Sinusitis, Draf I or IIa
- What is being tested?
- Endoscopic direct Draf IIa and Endoscopic angled Draf IIa
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients (aged 18 and above) with chronic rhino sinusitis affecting the frontal sinus with or without nasal polyps confirmed by nasal endoscopy and CT scan.
- Unilateral or bilateral cases.
- Denovo or recurrent cases.
Who cannot join
- Individuals younger than 18 year-old.
- Neoplasms
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Patients with chronic rhinosinusitis with frontal sinus affection indicated for sinuscopy will be randomly categorized in 2 groups: group A will have endoscopic directDraf IIa frontal sinusotomy and group B will have endoscopic angled Draf IIa frontal sinusotomy, the two groups will be compared according to ostium patency and perioperative morbidity
Read the detailed description
Frontal sinus surgery is a challenging component of endoscopic sinus surgery due to the intricacy and variability of frontal recess and sinus anatomy. Before the introduction of endoscopy in sinus surgery, complex cases of the frontal sinus were managed through the anterior wall using an osteoplastic flap approach. This technique was relatively successful in treating frontal sinus pathologies, but was invasive with adverse effects and failure in 6-25 percent of patients.
Different endoscopic techniques have been introduced for performing frontal sinusotomy. Draf categorized them into four techniques (Draf I, Draf IIa, Draf IIb, Draf III). Draf II procedures widen the frontal sinus outflow tract from the lamina papyracea laterally to the middle turbinate (Draf IIa) or the nasal septum medially (Draf IIb).
The thickness of the nasofrontal beak, and a limited anterior-posterior dimension of the frontal recess, make the Draf IIa frontal sinus surgery with angled endoscopy and instrumentation visually diffcult and requires skilled dexterity.
The direct access or Carolyn's window approach to the frontal recess replicates Draf's technique via the endoscopic approach. The approach utilizes only the 0° endoscope. In this approach, the entire frontal process of the maxilla, agger nasi and nasal process of the frontal bone, is removed with a high-speed drill.The goal of the approach is to visualize all walls of the frontal sinus via a ° endoscope. This postoperative view predicts better irrigation access and drainage of the frontal sinuses.
- Conditions
- Chronic Rhinosinusitis (CRS), Frontal Sinusitis, Draf I or IIa, Functional Endoscopic Sinus Surgery (FESS)
- Being tested
- Endoscopic direct Draf IIa, Endoscopic angled Draf IIa
- Keywords
- Frontal sinusitis, Direct Draf, Endoscopic sinus surgery
- Medical subject headings
- Frontal Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic direct Draf IIaProcedure or surgery
Endoscopic direct Draf IIa (Carolyn' window approach) frontal sinusotomy
Endoscopic angled Draf IIaProcedure or surgery
Group BFrontal sinusotomy using angled endoscopeand instruments
| Study group | Role | What they receive |
|---|---|---|
| First arm | Experimental | Endoscopic direct Draf IIa (Carolyn' window approach) frontal sinusotomy Receives: Procedure: Endoscopic direct Draf IIa |
| Second arm | Active comparator | Endoscopic angled Draf IIa frontal sinuaotomy Receives: Procedure: Endoscopic angled Draf IIa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess endoscopic direct access Draf IIa (carolyn's window approach) in creating patent frontal sinusotomy.
Assess endoscopic direct access Draf IIa (carolyn's window approach) in creating patent frontal sinusotomy assessment will be done radiologically after 6 months : it will be considered patent if ostium more than 5mm
Measured: 2 years
Secondary outcomes (1)
Assess perioperative morbidity of endoscopic direct Draf IIa approach compared to endoscopic Draf IIa frontal sinusotomy with an angled endoscope and instrumentation
Assess perioperative morbidity of endoscopic direct Draf IIa approach compared to endoscopic Draf IIa frontal sinusotomy with an angled endoscope and instrumentation Defined as early (< 90 days) or late (> 90 days). Early morbidity: including
- bleeding (requiring intervention)
- pain (requiring additional analgesia)
- crusting (requiring additional post-op visit)
- adhesions (any)
- cerebrospinal fluid leak
- periorbital edema or hematoma
- inferior-based lateral wall mucosal flap necrosis. Late morbidity: including epiphora and smell reduction from baseline.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis (CRS)Studies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazem Gamal Noreldein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668844
- Sponsor's protocol ID
- Endoscopic direct Draf IIa
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Barham HP, Hall CA, Hernandez SC, Zylicz HE, Stevenson MM, Zito BA, Harvey RJ. Impact of Draf III, Draf IIb, and Draf IIa frontal sinus surgery on nasal irrigation distribution. Int Forum Allergy Rhinol. 2020 Jan;10(1):49-52. doi: 10.1002/alr.22447. Epub 2019 Dec 11.
PubMed 31826329Spielman DB, Kim M, Overdevest J, Gudis DA. Zero-Degree Endoscopic Visualization of the Frontal Sinus Predicts Improved Topical Irrigation Delivery. Laryngoscope. 2021 Feb;131(2):250-254. doi: 10.1002/lary.28654. Epub 2020 Apr 11.
PubMed 32277702Seresirikachorn K, Sit A, Png LH, Kalish L, Campbell RG, Alvarado R, Harvey RJ. Carolyn's Window Approach to Unilateral Frontal Sinus Surgery. Laryngoscope. 2023 Oct;133(10):2496-2501. doi: 10.1002/lary.30569. Epub 2023 Jan 18.
PubMed 36651461Weber R, Draf W, Kratzsch B, Hosemann W, Schaefer SD. Modern concepts of frontal sinus surgery. Laryngoscope. 2001 Jan;111(1):137-46. doi: 10.1097/00005537-200101000-00024.
PubMed 11192882Hajbeygi M, Nadjafi A, Amali A, Saedi B, Sadrehosseini SM. Frontal Sinus Patency after Extended Frontal Sinusotomy Type III. Iran J Otorhinolaryngol. 2016 Sep;28(88):337-343.
PubMed 27738610Pagella F, Maiorano E, Turri-Zanoni M, Ferrari M, Carena P, Zoia C, Czaczkes C, Conti C, Schreiber A, Battaglia P, Emanuelli E, Pelucchi S, Bignami M, Nicolai P, Castelnuovo P. The role of the osteoplastic flap in the endoscopic era: a retrospective multicentre experience on revision surgery. Acta Otorhinolaryngol Ital. 2023 Apr;43(Suppl. 1):S34-S40. doi: 10.14639/0392-100X-suppl.1-43-2023-04.
PubMed 37698098Wormald PJ, Bassiouni A, Callejas CA, Kennedy DW, Citardi MJ, Smith TL, Orlandi RR, Kaschke O, Siow JK, Szczygielski K, Lund V, Fokkens W, Psaltis AJ. The International Classification of the radiological Complexity (ICC) of frontal recess and frontal sinus. Int Forum Allergy Rhinol. 2017 Apr;7(4):332-337. doi: 10.1002/alr.21893. Epub 2016 Dec 5.
PubMed 27918154
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Direct "Draf IIa" (Carolyn's Window Approach) Versus Endoscopic Angled "Draf IIa"Approach in Chronic Rhinosinusitis With Frontal Sinus Affection ( A Comparative Study ).
- ClinicalTrials.gov ID
- NCT06668844
- Acronym / sponsor ID
- Endoscopic direct Draf IIa
- Conditions
- Chronic Rhinosinusitis (CRS), Frontal Sinusitis, Draf I or IIa, Functional Endoscopic Sinus Surgery (FESS)
- Keywords
- Frontal sinusitis, Direct Draf, Endoscopic sinus surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 31 Oct 2024 (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.
Patients with chronic rhinosinusitis with frontal sinus affection indicated for sinuscopy will be randomly categorized in 2 groups: group A will have endoscopic directDraf IIa frontal sinusotomy and group B will have endoscopic angled Draf IIa frontal sinusotomy, the two groups will be compared according to ostium patency and perioperative morbidity
Detailed description
Frontal sinus surgery is a challenging component of endoscopic sinus surgery due to the intricacy and variability of frontal recess and sinus anatomy. Before the introduction of endoscopy in sinus surgery, complex cases of the frontal sinus were managed through the anterior wall using an osteoplastic flap approach. This technique was relatively successful in treating frontal sinus pathologies, but was invasive with adverse effects and failure in 6-25 percent of patients.
Different endoscopic techniques have been introduced for performing frontal sinusotomy. Draf categorized them into four techniques (Draf I, Draf IIa, Draf IIb, Draf III). Draf II procedures widen the frontal sinus outflow tract from the lamina papyracea laterally to the middle turbinate (Draf IIa) or the nasal septum medially (Draf IIb).
The thickness of the nasofrontal beak, and a limited anterior-posterior dimension of the frontal recess, make the Draf IIa frontal sinus surgery with angled endoscopy and instrumentation visually diffcult and requires skilled dexterity.
The direct access or Carolyn's window approach to the frontal recess replicates Draf's technique via the endoscopic approach. The approach utilizes only the 0° endoscope. In this approach, the entire frontal process of the maxilla, agger nasi and nasal process of the frontal bone, is removed with a high-speed drill.The goal of the approach is to visualize all walls of the frontal sinus via a ° endoscope. This postoperative view predicts better irrigation access and drainage of the frontal sinuses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First arm | Experimental | Procedure: Endoscopic direct Draf IIaEndoscopic direct Draf IIa (Carolyn' window approach) frontal sinusotomy |
| Second arm | Active comparator | Procedure: Endoscopic angled Draf IIaEndoscopic angled Draf IIa frontal sinuaotomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult patients (aged 18 and above) with chronic rhino sinusitis affecting the frontal sinus with or without nasal polyps confirmed by nasal endoscopy and CT scan.
- Unilateral or bilateral cases.
- Denovo or recurrent cases.
Key exclusion criteria (2 listed)
- Individuals younger than 18 year-old.
- Neoplasms
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 direct Draf IIaEndoscopic direct Draf IIa (Carolyn' window approach) frontal sinusotomy | Procedure or surgery | First arm |
| Endoscopic angled Draf IIaGroup BFrontal sinusotomy using angled endoscopeand instruments | Procedure or surgery | Second arm |
Primary outcome
Assess endoscopic direct access Draf IIa (carolyn's window approach) in creating patent frontal sinusotomy.
Time frame: 2 years
Assess endoscopic direct access Draf IIa (carolyn's window approach) in creating patent frontal sinusotomy assessment will be done radiologically after 6 months : it will be considered patent if ostium more than 5mm
1 secondary outcome
Assess perioperative morbidity of endoscopic direct Draf IIa approach compared to endoscopic Draf IIa frontal sinusotomy with an angled endoscope and instrumentation
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Background: PubMed 31826329Barham HP, Hall CA, Hernandez SC, Zylicz HE, Stevenson MM, Zito BA, Harvey RJ. Impact of Draf III, Draf IIb, and Draf IIa frontal sinus surgery on nasal irrigation distribution. Int Forum Allergy Rhinol. 2020 Jan;10(1):49-52. doi: 10.1002/alr.22447. Epub 2019 Dec 11.
- Background: PubMed 32277702Spielman DB, Kim M, Overdevest J, Gudis DA. Zero-Degree Endoscopic Visualization of the Frontal Sinus Predicts Improved Topical Irrigation Delivery. Laryngoscope. 2021 Feb;131(2):250-254. doi: 10.1002/lary.28654. Epub 2020 Apr 11.
- Background: PubMed 36651461Seresirikachorn K, Sit A, Png LH, Kalish L, Campbell RG, Alvarado R, Harvey RJ. Carolyn's Window Approach to Unilateral Frontal Sinus Surgery. Laryngoscope. 2023 Oct;133(10):2496-2501. doi: 10.1002/lary.30569. Epub 2023 Jan 18.
- Background: PubMed 11192882Weber R, Draf W, Kratzsch B, Hosemann W, Schaefer SD. Modern concepts of frontal sinus surgery. Laryngoscope. 2001 Jan;111(1):137-46. doi: 10.1097/00005537-200101000-00024.
- Background: PubMed 27738610Hajbeygi M, Nadjafi A, Amali A, Saedi B, Sadrehosseini SM. Frontal Sinus Patency after Extended Frontal Sinusotomy Type III. Iran J Otorhinolaryngol. 2016 Sep;28(88):337-343.
- Background: PubMed 37698098Pagella F, Maiorano E, Turri-Zanoni M, Ferrari M, Carena P, Zoia C, Czaczkes C, Conti C, Schreiber A, Battaglia P, Emanuelli E, Pelucchi S, Bignami M, Nicolai P, Castelnuovo P. The role of the osteoplastic flap in the endoscopic era: a retrospective multicentre experience on revision surgery. Acta Otorhinolaryngol Ital. 2023 Apr;43(Suppl. 1):S34-S40. doi: 10.14639/0392-100X-suppl.1-43-2023-04.
- Background: PubMed 27918154Wormald PJ, Bassiouni A, Callejas CA, Kennedy DW, Citardi MJ, Smith TL, Orlandi RR, Kaschke O, Siow JK, Szczygielski K, Lund V, Fokkens W, Psaltis AJ. The International Classification of the radiological Complexity (ICC) of frontal recess and frontal sinus. Int Forum Allergy Rhinol. 2017 Apr;7(4):332-337. doi: 10.1002/alr.21893. Epub 2016 Dec 5.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic direct Draf IIa and Endoscopic angled Draf IIa in people with Chronic Rhinosinusitis (CRS) and Frontal Sinusitis, run by Assiut University.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hazem Gamal Noreldin, Assistant lecturer (01024806122, Hazzmnoreldin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess endoscopic direct access Draf IIa (carolyn's window approach) in creating patent frontal sinusotomy. (time frame: 2 years). 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 NCT06668844, which also lists 7 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 31 Oct 2024.