Comparison Between Coblation Versus Bipolar Diathermy in Management of Refractory Idiopathic Recurrent Anterior Epistaxis in Children.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 主要终点
- Number of participants with successful hemostasis on the day of the procedure.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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-
- •Bleeding originating from Kiesselbach's plexus, located in the anteroinferior portion of the nasal septum.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: bipolar diathermy "Standard technique". (Procedure)
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.
干预措施: coblation technique. (Procedure)
结局指标
主要结局
Number of participants with successful hemostasis on the day of the procedure.
时间窗: The first 24 hours postoperative
No epistaxis within the first 24 hours of the procedure.
次要结局
- Postoperative complications(6 months)
研究者
Abanoub Hosni Anwar Mejalli
Principal investigator
Assiut University