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

June 26, 2023 updated by: Mahmoud Mohamed Aly Hamam, Sohag University
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: six months
Thyroid hormone levels will be assessed after auto transplantation of thyroid tissue from benign thyroid patients following total thyroidectomy
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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