ClinicalTrials.gg
Not yet recruitingNCT06651840Updated Feb 19, 2025

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

An interventional study of bipolar diathermy "Standard technique". and coblation technique. in Epistaxis Nosebleed, sponsored by Assiut University. Not yet recruiting. Open to participants aged 6 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-19.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
6 Years to 17 Years
Sex
All
01

Study 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.
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.

02

Conditions studied

  • Epistaxis Nosebleed

Browse trials for

03

In context

Epistaxis

96 studies on the registry are indexed under Epistaxis; 22 are open to participants now.

This study's planned enrollment of 64 is close to the median of 64 across 81 interventional studies indexed under Epistaxis.

Browse Epistaxis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
64 participants (estimated)

Study arms

  • 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".

  • 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.

Interventions

  • Procedurebipolar 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.

  • Procedurecoblation 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.

06

What researchers measure

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.

    Time frame: The first 24 hours postoperative

Secondary outcomes

  1. Postoperative complications

    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.

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2025; primary completion for Dec 2025, 9 months later.

Of 24 interventional studies with no phase under Epistaxis, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 25. This study's planned 9 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2024
First posted
Oct 22, 2024
StartEst.
Mar 1, 2025
Primary completionEst.
Dec 2025
CompletionEst.
Jan 2026
Last update
Feb 19, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06651840
Lead sponsor
Assiut University
Responsible party
Abanoub Hosni Anwar Mejalli (Principal investigator, Assiut University) — Principal investigator
First posted
Oct 22, 2024
Start date
Mar 1, 2025 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Jan 2026 (estimated)
Last update
Feb 19, 2025

Study contacts

Abanoub H Mejalli
Contact
abanobhosni@gmail.com
01288547168
Aly R Selim, Professor
study chair · Professor
Shimaa I Abdallah, Ass.Prof
study director · Assistant Professor

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion