Endoscopic Direct "Draf IIa" (Carolyn's Window Approach) Versus Endoscopic Angled "Draf IIa"Approach in Chronic Rhinosinusitis With Frontal Sinus Affection ( A Comparative 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

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Key information

Conditions

Chronic Rhinosinusitis (CRS) Draf I or IIa Frontal Sinusitis Functional Endoscopic Sinus Surgery (FESS) Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections Sinusitis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Individuals younger than 18 year-old.
Neoplasms

Treatment and study plan

Endoscopic direct Draf IIa

Procedure

Endoscopic direct Draf IIa (Carolyn' window approach) frontal sinusotomy

Endoscopic angled Draf IIa

Procedure

Group BFrontal sinusotomy using angled endoscopeand instruments

Primary outcomes

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

Secondary outcomes

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
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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hazem Gamal Noreldin, Assistant lecturer

CONTACT

[email protected]

01024806122

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Oct 31, 2024
Registry last updated: Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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