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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Thyroid Diseases
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with benign multi nodular goiter

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: Soh-Med-23-06-04MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No