Thyroid Autotransplantation in Quadriceps Femoris Muscle

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Implantation of Thyroid Gland After Total Thyroidectomy in Quadriceps Femoris Muscle

Conditions
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Thyroid

Intervention / Treatment
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* Procedure: Throid autotransplantation
* Drug: Hormone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult male or female with simple nodular goitre. patients who are fit for surgery. Exclusion Criteria: children (male or female) patients with malignant or recurrent goitre patients who are unfit for surgery

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thyroid autotransplantation<br>Implantation of 5-10 gm thyroid gland after mincing it in saline in quadriceps femoris muscle. | Procedure: Throid autotransplantation<br>* Operative<br>|
| Other: control group<br>the patients in this group won't undergo thyroid autotransplantation. instead, hormonal replacement therapy shall be prescribed for them. | Drug: Hormone<br>* thyroid hormone replacement therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| normal level of thyroid hormone, and thyroid stimulating hormone |  | One year |