Coblation Versus Bipolar Diathermy in Management of Refractory Idiopathic Recurrent Anterior Epistaxis in Children.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorAssiut University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • bipolar diathermy "Standard technique".

    Procedure/Surgery

    The 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/Surgery

    The 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

64 Participants
are divided into 2 treatment groups
Group A: Group A: patients in this group will be managed with bipolar diathermy "Standard technique".Active comparator 1 intervention
Group B: Group B: patients in this group will be managed with coblation technique.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with successful hemostasis on the day of the procedure.

No epistaxis within the first 24 hours of the procedure.

Time frame
The first 24 hours postoperative

Secondary outcomes

1

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.

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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