Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651840
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-19
Brief Title:
Coblation Versus Bipolar Diathermy in Management of Refractory Idiopathic Recurrent Anterior Epistaxis in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison Between Coblation Versus Bipolar Diathermy in Management of Refractory Idiopathic Recurrent Anterior Epistaxis in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Kiesselbachs 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 doesnt 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None