About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Individuals younger than 18 year-old.
Neoplasms
Trial design
Parallel
Treatments tested in this trial
Endoscopic direct Draf IIa
Procedure/SurgeryEndoscopic direct Draf IIa (Carolyn' window approach) frontal sinusotomy
Endoscopic angled Draf IIa
Procedure/SurgeryGroup BFrontal sinusotomy using angled endoscopeand instruments
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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 1. bleeding (requiring intervention) 2. pain (requiring additional analgesia) 3. crusting (requiring additional post-op visit) 4. adhesions (any) 5. cerebrospinal fluid leak 6. periorbital edema or hematoma 7. inferior-based lateral wall mucosal flap necrosis. Late morbidity: including epiphora and smell reduction from baseline.
Locations
Sponsors and contacts
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