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Thyroid Autotransplantation in Quadriceps Femoris Muscle

A

Assiut University

Status

Unknown

Conditions

Thyroid

Treatments

Drug: Hormone
Procedure: Throid autotransplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT04684953
thyroid autotransplantation

Details and patient eligibility

About

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.

Full 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).

Enrollment

40 estimated patients

Sex

All

Ages

15 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Thyroid autotransplantation
Active Comparator group
Description:
Implantation of 5-10 gm thyroid gland after mincing it in saline in quadriceps femoris muscle.
Treatment:
Procedure: Throid autotransplantation
control group
Other group
Description:
the patients in this group won't undergo thyroid autotransplantation. instead, hormonal replacement therapy shall be prescribed for them.
Treatment:
Drug: Hormone

Trial contacts and locations

0

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Central trial contact

Abdullah Badawy, professor; Mohamed A Hassan

Data sourced from clinicaltrials.gov

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