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临床试验/NCT04684953
NCT04684953Unknown不适用

Implantation of Thyroid Gland After Total Thyroidectomy in Quadriceps Femoris Muscle

Assiut University0 个研究点目标入组 40 人开始时间: 2022年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
40
主要终点
normal level of thyroid hormone, and thyroid stimulating hormone

研究概览

简要总结

providing an almost natural ectopic thyroid in patients undergoing total thyroidectomy, remains a challenging subject that can benefits patients with a non-pharmacological substitute for their normal gland. this study seeks to prove that thyroid autotransplantation is possible and reliable.

详细描述

Total thyroidectomy, rather thyroidectomy, is currently widely accepted as the modality of choice for treatment of benign thyroid disorders that require surgical excision. The goal of post-thyroidectomy management is to reach a "safe physiological status" of thyroid hormonal profile. Although exogenous levothyroxine replacement has long been safely used as a replacement after total thyroidectomy, it is not considered optimal, as it is bounded by patient's compliance with the treatment and follow-up schedule, effect of mal-absorption, and the inability to compensate for daily physiological alterations.

The concept of endocrinal tissue auto-transplantation has been largely investigated in the case of parathyroid gland, and to a lesser extent for pancreatic islets. Although both the experimental studies of thyroid autotransplantation and the early case reports of lingual thyroid autotransplantations have shown encouraging results, a very limited number of clinical studies investigated thyroid autotransplantation in adult patients with benign thyroid disorders. Moreover, the discrepancy in the patients' characteristics and thyroid autotransplantation technique in these studies hinders the standardization of thyroid autotransplantation for clinical practice. Hypothetically, thyroid autotransplantation offers and attractive alternative for subtotal thyroidectomy, as it enables the preservation of native responsive thyroid tissue in an accessible location, and, thus, evades the risk of possible regrowth in the neck region. The present preliminary clinical study is conducted to investigate the feasibility and outcome of thyroid autotransplantation after total thyroidectomy for patients with benign thyroid disorders (other than thyroiditis).

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
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • adult male or female with simple nodular goitre.
  • patients who are fit for surgery.

排除标准

  • children (male or female)
  • patients with malignant or recurrent goitre
  • patients who are unfit for surgery

研究组 & 干预措施

Thyroid autotransplantation

Active Comparator

Implantation of 5-10 gm thyroid gland after mincing it in saline in quadriceps femoris muscle.

干预措施: Throid autotransplantation (Procedure)

control group

Other

the patients in this group won't undergo thyroid autotransplantation. instead, hormonal replacement therapy shall be prescribed for them.

干预措施: Hormone (Drug)

结局指标

主要结局

normal level of thyroid hormone, and thyroid stimulating hormone

时间窗: One year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Ahmed Hassan Aly

Resident surgeon

Assiut University

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