Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Swallowing Impairment Score (SIS).
研究概览
简要总结
The scientific interest of this study is to improve post-operative comfort in patients after thyroid surgery using simple, inexpensive techniques. The investigator expects that local applications of ice or cortisone aerosols will reduce swallowing discomfort and control post-operative pain (POP). The investigator hopes that local cryotherapy will decrease post-operative oedema (vasoconstriction) and the volume of liquid drained (action on the serous fluid at the site of the thyroidectomy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients about to undergo total thyroidectomy by cervicotomy
- •Single surgeon: Dr Osmak-Tizon Liliana
- •Patients who have provided written consent to take part in the research
- •Hospitalized in the endocrine surgery unit
- •Whose mental and physical state allows them to participate in the quantification of a symptom using a Visual Analogue Scale(VAS)
排除标准
- •Patients under 18 or adults under guardianship
- •Patients about to undergo unilateral thyroid surgery (thyroid lobectomy)
- •Patient who have had parathyroid surgery
- •History of cervicotomy
- •Intolerance to, contra-indication for or allergy to any of the treatments tested.
- •Pregnant or breast-feeding women
- •Patients without national health insurance cover
研究组 & 干预措施
cryotherapy
干预措施: thyroidectomy (Procedure)
cryotherapy
干预措施: cryotherapy (Other)
cryotherapy
干预措施: Dexamethasone acetate (Drug)
cryotherapy
干预措施: paracetamol (Drug)
Cortisone aerosol
干预措施: thyroidectomy (Procedure)
Cortisone aerosol
干预措施: cortisone aerosol (Drug)
Cortisone aerosol
干预措施: Dexamethasone acetate (Drug)
Cortisone aerosol
干预措施: paracetamol (Drug)
Management
干预措施: thyroidectomy (Procedure)
Management
干预措施: Dexamethasone acetate (Drug)
Management
干预措施: paracetamol (Drug)
结局指标
主要结局
Swallowing Impairment Score (SIS).
时间窗: Evolution of the SIS from baseline (inclusion), to the end of the surgery and every day thereafter until discharge of the patient(up to 3 months)
次要结局
未报告次要终点