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Outcomes of Thyroid Auto Transplantation Following Total Thyroidectomy in Benign Thyroid Disorders Protocol

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ClinicalTrials.gov Identifier: NCT05930977
Recruitment Status : Enrolling by invitation
First Posted : July 5, 2023
Last Update Posted : July 5, 2023
Sponsor:
Information provided by (Responsible Party):
Mahmoud Mohamed Aly Hamam, Sohag University

Study Description
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Brief Summary:
the study aimed at evaluating efficacy of auto-transplantation of thyroid tissue after total thyroidectomy in benign thyroid disorders to keep the patient euthyroid with no need for life long hormone replacement therapy.

Condition or disease Intervention/treatment
Thyroid Diseases Procedure: total thyroidectomy followed by thyroid auto transplantation

Detailed Description:
This study will be a prospective study which will be conducted at Sohag University Hospital after approval of the protocol the study population include . Adult patients with goiters are seen in the general surgery outpatient clinic The study included thirty studied cases presented in the outpatient clinic with benign thyroid disorders for whom total thyroidectomy was performed
Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Outcomes of Thyroid Auto Transplantation Following Total Thyroidectomy in Benign Thyroid Disorders Protocol
Actual Study Start Date : June 1, 2023
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

Groups and Cohorts
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Group/Cohort Intervention/treatment
patient undergone total thyroidectomy followed by thyroid auto transplantation Procedure: total thyroidectomy followed by thyroid auto transplantation

All studied cases received general endotracheal anaesthesia, and all underwent total thyroidectomy.

Frozen section will be done intraoperative to exclude malignancy and obtain piece of healthy tissue part .

Most healthy-looking part of gland was selected after complete excision. Thyroid tissue to be transplanted weighed between two and five grammes. This section was finely split into ten-fifteen fragments with scalpel. Small pocket was created in sternomastoid muscle, into which these minor fragments were implanted, and this pocket was closed with absorbable sutures to prevent displacement of implanted fragments and was marked with metallic stables, as well as good hemostasis of thyroid bed and skin was closed with subcuticular sutures using absorbable three-zero Vicryl sutures.


Outcome Measures
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Primary Outcome Measures :
  1. Thyroid function following thyroid auto transplantation after total thyroidectomy [ Time Frame: six months ]
    Thyroid hormone levels will be assessed after auto transplantation of thyroid tissue from benign thyroid patients following total thyroidectomy


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with benign multi nodular goiter
Criteria

Inclusion Criteria:

  • Patients proved to have benign thyroid disorders operable and candidate for total thyroidectomy Adult patients who agreed and consented to do the procedure.

Exclusion Criteria:

  • Patients with high suspicion of malignancy , unfit and refused the procedure
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05930977


Locations
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Egypt
Sohag University
Sohag, Egypt
Sponsors and Collaborators
Sohag University
More Information
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Responsible Party: Mahmoud Mohamed Aly Hamam, Mahmoud Mahamed Aly, Sohag University
ClinicalTrials.gov Identifier: NCT05930977    
Other Study ID Numbers: Soh-Med-23-06-04MS
First Posted: July 5, 2023    Key Record Dates
Last Update Posted: July 5, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thyroid Diseases
Endocrine System Diseases