NCT05930977

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

July 5, 2023

Status Verified

June 1, 2023

Enrollment Period

8 months

First QC Date

June 15, 2023

Last Update Submit

June 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

patient undergone total thyroidectomy followed by thyroid auto transplantation

Procedure: total thyroidectomy followed by thyroid auto transplantation

Interventions

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.

patient undergone total thyroidectomy followed by thyroid auto transplantation

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with benign multi nodular goiter

You may qualify if:

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

You may not qualify if:

  • Patients with high suspicion of malignancy , unfit and refused the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Egypt

Location

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mahmoud Mahamed Aly

Study Record Dates

First Submitted

June 15, 2023

First Posted

July 5, 2023

Study Start

June 1, 2023

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

July 5, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations