About this trial
The aim of this study is to compare the outcomes of coblation technique versus bipolar technique in management of RAE in children regarding the following:
1. Efficacy of each method to stop bleeding. 2. Technical feasibility. 3. Mucosal healing and crust formation. 4. Post operative complications like: synechia formation and septal perforation. 5. Nostril stenosis/ atresia.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
A history of repeated unilateral epistaxis with at least four episodes, at least one episode per week during the preceding 4 weeks.
Age > 5 years of age and < 18 years of age.
Failure of topical treatment with an antiseptic ointment, with or without silver nitrate cautery.
A Katsanis epistaxis scoring system (ESS) score of 7-10.
Disqualifiers
Patients < 5 years of age and >= 18 years of age.
Patients with bilateral epistaxis.
Patients with bleeding tendencies like: Hemophilia, Leukemia, Idiopathic thrombocytopenic purpura, Von Willebrand disease and Thrombasthenia.
Patients with previous nasal surgeries.
Trial design
Parallel
Treatments tested in this trial
bipolar diathermy "Standard technique".
Procedure/SurgeryThe bipolar technique for group A: A bipolar with straight blade will be used with a footplate-operated switch to control the coagulation time, and the length, width and depth of penetration of the thermal power. The lesion will be coagulated in a distal-to-proximal direction to achieve a uniform gray-white coagulation zone in the lesion and surrounding tissue. Multiple ablations at the same area should be avoided to avoid septal perforation. After finishing coagulation small gauze impregnated with antibiotic ointment will be applied for 2 hours postoperatively.
coblation technique.
Procedure/SurgeryThe coblation technique for group B: An coblator with tonsillar blade will be used with a footplate-operated switch to control the coagulation time, and the length, width and depth of penetration of the thermal power. The lesion will be coagulated in a distal-to-proximal direction to achieve a uniform gray-white coagulation zone in the lesion and surrounding tissue. Multiple ablations at the same area should be avoided to avoid septal perforation. After finishing coagulation small gauze impregnated with antibiotic ointment will be applied for 2 hours postoperatively.
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with successful hemostasis on the day of the procedure.
No epistaxis within the first 24 hours of the procedure.
Secondary outcomes
Postoperative complications
1. Rate of rebleeding rates at 1 and 4 weeks, and 6 months. 2. Rate of mucosal healing. 3. Rate of postoperative crust formation. 4. Rate of postoperative synechiae formation. 5. Rate of postoperative septal perforation.
Locations
Sponsors and contacts
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