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临床试验/NCT05367869
NCT05367869Unknown不适用

Impact of Intraoperative Spraying Methylene Blue In Thyroidectomy

Qena Oncology Center0 个研究点目标入组 40 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
主要终点
Presence of residual or recurrence

研究概览

简要总结

Impact of Intraoperative Spraying methylene blue In thyroidectomy

详细描述

General anaesthesia ,supine position with hyperextension to the neck Low collar incision to the neck , incision to the skin and platysma muscle and fascia ,upper and lower flaps are developed ,separation of strap muscles and identification of the thyroid gland after freeing of investing fascia Ligation of the middle thyroid vein and ligation and separation of the superior pedicle away from the external laryngeal nerve At this point of operation and before ligation of inferior pedicle, methylene blue 0.05% spraying is applied to the field the amount varies according to size of the thyroid lobe and variation in population and neck size Thyroid gland stained by bluish color , recurrent laryngeal nerve not stained or minimally stained so we can avoid injury to it parathyroid glands get red of the stain after about 3 minutes so we can avoid injury to it thyroid gland lose its stain in about 15 minutes so we can remove any residual and decrease residual tissue or recurrence

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both sexes
  • Age more than 15 years
  • All pathologies need surgery eg. (mutinodular goiter, malignancy , thyroid nodule,.....etc
  • Total thyroidectomy

排除标准

  • Pregnant females
  • Previous neck surgery or recurrent thyroid surgery
  • Subtotal or partial thyroidectomy
  • Age less than 15 years
  • Preoperative affection to vocal cord
  • Preoperative hypocalcaemia

结局指标

主要结局

Presence of residual or recurrence

时间窗: 3 months

Recurrent laryngeal nerve injury

时间窗: 2 weeks

Operative time

时间窗: 1 day

Intraoperative injury to trachea

时间窗: 2 weeks

Parathyroid gland Injuries

时间窗: 3 months

次要结局

  • Stridor(3 months)
  • Hypoparathyroidism(3 months)
  • Hoarseness of voice(3 months)
  • Hypocalcaemia(3 months)

研究者

发起方
Qena Oncology Center
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mohamed Ahmed Orabi

specialist of Surgical Oncology

Qena Oncology Center

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