Clinical trial NCT06651840: Coblation Versus Bipolar Diathermy in Management of Refractory Idiopathic Recurrent Anterior Epistaxis in Children.
Official title: Comparison Between Coblation Versus Bipolar Diathermy in Management of Refractory Idiopathic Recurrent Anterior Epistaxis in Children.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epistaxis Nosebleed
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Epistaxis commonly referred to as "nosebleed" remains to be one of the most common ENT emergencies presenting to the accident and emergency departments (AED) worldwide. Idiopathic epistaxis is a common complaint seen in children in rhinology outpatient clinics. In most pediatric cases, idiopathic epistaxis originates from Kiesselbach's plexus, which is located in the anteroinferior portion of the nasal septum; thus, this condition is also known as recurrent anterior epistaxis (RAE). The ideal treatment for idiopathic RAE has yet to be elucidated. In most cases only leaning forwards, pinching of the nose and washing of the face and nose with cold water is all that is needed to stop the epistaxis; in other cases, more aggressive interventions as using nasal packing or chemical cauterization are needed. Although silver nitrate cautery is the most common method of chemical cautery for the treatment of RAE, it has mainly been used to control bleeding associated with small vessels and ulceration of the nasal mucosa . Electrosurgery appears to be more effective than silver nitrate in controlling bleeding telangiectasias. Johnson et al. suggested that bipolar electrocautery may be a superior treatment in children with RAE at risk of severe bleeding, in whom chemical cautery will likely fail. Coblation is a minimally invasive therapeutic technique that can cover a large tissue volume, thus allowing for rapid ablation and a large area of coagulation with minimal side effects. Review of the available literatures doesn't compare between these two methods "Bipolar versus coblation regarding their efficacy to control RAE in children". In this research we will study the outcomes of both techniques.

Eligibility criteria: Inclusion Criteria:

1. A history of repeated unilateral epistaxis with at least four episodes, at least one episode per week during the preceding 4 weeks.
2. Age \> 5 years of age and \< 18 years of age.
3. Failure of topical treatment with an antiseptic ointment, with or without silver nitrate cautery.
4. A Katsanis epistaxis scoring system (ESS) score of 7-10.
5. Bleeding originating from Kiesselbach's plexus, located in the anteroinferior portion of the nasal septum.

Exclusion Criteria:

1. Patients \< 5 years of age and \>= 18 years of age.
2. Patients with bilateral epistaxis.
3. Patients with bleeding tendencies like: Hemophilia, Leukemia, Idiopathic thrombocytopenic purpura, Von Willebrand disease and Thrombasthenia.
4. Patients with previous nasal surgeries.
5. Patients with hereditary hemorrhagic telangiectasia.
6. Patients with vascular lesions like: angiofibroma, pyogenic granuloma and bleeding polypus.
7. Patients who are unfit for surgery.

Primary outcomes:
measure: Number of participants with successful hemostasis on the day of the procedure.
timeFrame: The first 24 hours postoperative
Secondary outcomes:
measure: Postoperative complications
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Professor
name: Aly R Selim, Professor
role: STUDY_CHAIR
affiliation: Assistant Professor
name: Shimaa I Abdallah, Ass.Prof
role: STUDY_DIRECTOR
References:
citation: Lou ZC. Hemostasis of idiopathic recurrent epistaxis in children with microwave ablation: a prospective pilot case series. J Otolaryngol Head Neck Surg. 2019 Dec 18;48(1):72. doi: 10.1186/s40463-019-0393-0.