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 ).

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Chronic Rhinosinusitis (CRS)
• Frontal Sinusitis
• Draf I or IIa
• Functional Endoscopic Sinus Surgery (FESS)

Interventions

Type	Name	Description
PROCEDURE	Endoscopic direct Draf IIa	Endoscopic direct Draf IIa (Carolyn' window approach) frontal sinusotomy
PROCEDURE	Endoscopic angled Draf IIa	Group BFrontal sinusotomy using angled endoscopeand instruments

Timeline

• Start date: 2025-01-01
• Primary completion: 2028-01-01
• Completion: 2028-03-01
• First posted: 2024-10-31
• Last updated: 2024-10-31