Epistaxis NosebleedNCT06651840
Coblation Versus Bipolar Diathermy in Management of Refractory Idiopathic Recurrent Anterior Epistaxis in Children.
A study testing bipolar diathermy "Standard technique". and coblation technique. in people with Epistaxis Nosebleed, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Epistaxis Nosebleed
- What is being tested?
- bipolar diathermy "Standard technique". and coblation technique.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
- Efficacy of each method to stop bleeding.
- Technical feasibility.
- Mucosal healing and crust formation.
- Post operative complications like: synechia formation and septal perforation.
- Nostril stenosis/ atresia.
Read the 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.
- Conditions
- Epistaxis Nosebleed
- Being tested
- bipolar diathermy "Standard technique"., coblation technique.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bipolar diathermy "Standard technique".Procedure or 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 or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: coblation technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with successful hemostasis on the day of the procedure.
No epistaxis within the first 24 hours of the procedure.
Measured: The first 24 hours postoperative
Secondary outcomes (1)
Postoperative complications
- Rate of rebleeding rates at 1 and 4 weeks, and 6 months.
- Rate of mucosal healing.
- Rate of postoperative crust formation.
- Rate of postoperative synechiae formation.
- Rate of postoperative septal perforation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Mar 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epistaxis NosebleedStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abanoub Hosni Anwar Mejalli, Assiut University
- Investigators
- Aly R Selim, Professor, Study chair, ProfessorShimaa I Abdallah, Ass.Prof, Study director, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651840
- Sponsor's protocol ID
- Coblation in child's epistaxis
- Status last verified
- Feb 2025
- First submitted
- 19 Oct 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31852515
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Coblation Versus Bipolar Diathermy in Management of Refractory Idiopathic Recurrent Anterior Epistaxis in Children.
- ClinicalTrials.gov ID
- NCT06651840
- Acronym / sponsor ID
- Coblation in child's epistaxis
- Conditions
- Epistaxis Nosebleed
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Efficacy of each method to stop bleeding.
- Technical feasibility.
- Mucosal healing and crust formation.
- Post operative complications like: synechia formation and septal perforation.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: patients in this group will be managed with bipolar diathermy "Standard technique". | Active comparator | 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. |
| Group B: patients in this group will be managed with coblation technique. | Experimental | 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Group A: patients in this group will be managed with bipolar diathermy "Standard technique". |
| 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 or surgery | Group B: patients in this group will be managed with coblation technique. |
Primary outcome
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.
1 secondary outcome
Postoperative complications
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Background: PubMed 31852515Lou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aly R Selim, Professor study chair
Professor
Shimaa I Abdallah, Ass.Prof study director
Assistant Professor
Questions about this trial
What is this clinical trial studying?
A study testing bipolar diathermy "Standard technique". and coblation technique. in people with Epistaxis Nosebleed, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abanoub H Mejalli (01288547168, abanobhosni@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with successful hemostasis on the day of the procedure. (time frame: The first 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06651840, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.