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

Sponsor

Sohag University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05930977

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Type:

Observational

Anticipated 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 :

Jun 1, 2023

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

Arm	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.

Arm

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

Primary Outcome Measures

Thyroid function following thyroid auto transplantation after total thyroidectomy [six months]
Thyroid hormone levels will be assessed after auto transplantation of thyroid tissue from benign thyroid patients following total thyroidectomy

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Sohag University	Sohag		Egypt

Sponsors and Collaborators

Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Jul 5, 2023

Last Update Posted:

Jul 5, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thyroid Diseases

Study Results

No Results Posted as of Jul 5, 2023