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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05930977
Other study ID # Soh-Med-23-06-04MS
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date January 31, 2024

Study information

Verified date June 2023
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 30
Est. completion date January 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Egypt Sohag University Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Thyroid function following thyroid auto transplantation after total thyroidectomy Thyroid hormone levels will be assessed after auto transplantation of thyroid tissue from benign thyroid patients following total thyroidectomy six months
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