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

NCT06651840 | Not Yet Recruiting

• 1 other identifier: Coblation in child's epistaxis
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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. 1.Efficacy of each method to stop bleeding.
2. 2.Technical feasibility.
3. 3.Mucosal healing and crust formation.
4. 4.Post operative complications like: synechia formation and septal perforation.
5. 5.Nostril stenosis/ atresia.

Conditions

Epistaxis Nosebleed

Outcome Measures

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.

  The first 24 hours postoperative

Secondary Outcomes (1)

• Postoperative complications

  6 months

Study Arms (2)

Group A: patients in this group will be managed with bipolar diathermy "Standard technique".

ACTIVE COMPARATOR

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.

Procedure: bipolar diathermy "Standard technique".

Group B: patients in this group will be managed with coblation technique.

EXPERIMENTAL

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.

Procedure: coblation technique.

Interventions

bipolar diathermy "Standard technique". PROCEDURE

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.

Group A: patients in this group will be managed with bipolar diathermy "Standard technique".

coblation technique. PROCEDURE

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.

Group B: patients in this group will be managed with coblation technique.

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Bleeding originating from Kiesselbach's plexus, located in the anteroinferior portion of the nasal septum.

You may not qualify if:

• 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.
• Patients with hereditary hemorrhagic telangiectasia.
• Patients with vascular lesions like: angiofibroma, pyogenic granuloma and bleeding polypus.
• Patients who are unfit for surgery.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 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.

  PMID: 31852515 BACKGROUND

Study Officials

• Aly R Selim, Professor

  Professor

  STUDY CHAIR

• Shimaa I Abdallah, Ass.Prof

  Assistant Professor

  STUDY DIRECTOR

Central Study Contacts

Abanoub H Mejalli

CONTACT

01288547168; abanobhosni@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: October 22, 2024
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02