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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAssiut University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Endoscopic direct Draf IIa

    Procedure/Surgery

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

  • Endoscopic angled Draf IIa

    Procedure/Surgery

    Group BFrontal sinusotomy using angled endoscopeand instruments

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: First armExperimental treatment 1 intervention
Group B: Second armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
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 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.

Time frame
2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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