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

February 15, 2025 updated by: Abanoub Hosni Anwar Mejalli, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: patients in this group will be managed with bipolar diathermy "Standard technique".

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".

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

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with successful hemostasis on the day of the procedure.
Time Frame: The first 24 hours postoperative
No epistaxis within the first 24 hours of the procedure.
The first 24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 6 months
  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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Aly R Selim, Professor, Professor
  • Study Director: Shimaa I Abdallah, Ass.Prof, Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

October 19, 2024

First Submitted That Met QC Criteria

October 19, 2024

First Posted (Actual)

October 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 15, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Coblation in child's epistaxis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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