Clinical trial NCT04684953: Thyroid Autotransplantation in Quadriceps Femoris Muscle
Official title: Implantation of Thyroid Gland After Total Thyroidectomy in Quadriceps Femoris Muscle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: normal level of thyroid hormone, and thyroid stimulating hormone
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: general surgery professor
name: Abdullah Badawy, professor
role: STUDY_DIRECTOR
affiliation: general surgery professor
name: Ashraf Helmy, professor
role: STUDY_CHAIR
affiliation: general surgery professor
name: Mohamed M Saad Elshafey, professor
role: STUDY_CHAIR
affiliation: resident physician at general surgery
name: Mohamed A Hassan, resident
role: PRINCIPAL_INVESTIGATOR
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