A Prospective Observational Study on Sensory Changes, Analyzing Paresthesia/Hypoesthesia in the Neck and Anterior Chest Following Endoscopic Thyroidectomy via Axillo Breast and Bilateral Axillo Breast Approaches done for Benign or Cytologically Indeterminate lesion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To assess the incidence and resolution of neck and anterior chest paresthesia/hypoesthesia in patients undergoing endoscopic thyroidectomy via Axillo-breast and Bilateral Axillo-breast approaches done for Benign or Cytologically Indeterminate Lesions
研究概览
简要总结
Endoscopic Thyroidectomy has been a revolutionary invention in the evolution of thyroid surgeries. However, defining its commonly encountered complications and its impact on the quality of life, as it becomes prudent for both the patient and the surgeon so that they are made well aware of the impact of such complications in the postoperative period.Endoscopic Thyroidectomy has been a revolutionary invention in the evolution of thyroid surgeries. However, defining its commonly encountered complications and its impact on the quality of life, as it becomes prudent for both the patient and the surgeon so that they are made well aware of the impact of such complications in the postoperative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 years Benign or cytologically indeterminate lesions involving single lobe of size 6cm or 60cm or both lobes.
排除标准
- •Age below 18 yrs Refusal to give consent Patients not fit for general anaesthesia/neck extension required for surgical positioning History of head and neck surgery and previous irradiation 1 All thyroid lesions of size 6 cm or 60ml 2 All malignant lesions of thyroid 3 Evidence of active clinical hyperthyroidism or thyroiditis 4 Substernal thyroidal extension of swelling.
结局指标
主要结局
To assess the incidence and resolution of neck and anterior chest paresthesia/hypoesthesia in patients undergoing endoscopic thyroidectomy via Axillo-breast and Bilateral Axillo-breast approaches done for Benign or Cytologically Indeterminate Lesions
时间窗: preoperatively, postoperatively on day 1, 3, 7, 30, 90
次要结局
- To assess the impact of paresthesia/hypoesthesia in the neck & anterior chest wall & also other associated complications following endoscopic thyroidectomy via Axillo-breast & Bilateral Axillo-breast approaches done for Benign or Cytologically Indeterminate Lesions in terms of quality of life.(baseline before surgery)
研究者
Dr Anita Dhar
ALL INDIA INSTITUTE OF MEDICAL SCIENCES