NCT04684953

Brief Summary

providing an almost natural ectopic thyroid in patients undergoing total thyroidectomy, remains a challenging subject that can benefits patients with a non-pharmacological substitute for their normal gland. this study seeks to prove that thyroid autotransplantation is possible and reliable.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

9 months

First QC Date

December 22, 2020

Last Update Submit

January 7, 2022

Conditions

Thyroid

Outcome Measures

Primary Outcomes (1)

  • normal level of thyroid hormone, and thyroid stimulating hormone

    One year

Study Arms (2)

Thyroid autotransplantation

ACTIVE COMPARATOR

Implantation of 5-10 gm thyroid gland after mincing it in saline in quadriceps femoris muscle.

Procedure: Throid autotransplantation

control group

OTHER

the patients in this group won't undergo thyroid autotransplantation. instead, hormonal replacement therapy shall be prescribed for them.

Drug: Hormone

Interventions

Throid autotransplantationPROCEDURE

Operative

Thyroid autotransplantation
HormoneDRUG

thyroid hormone replacement therapy

control group

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • adult male or female with simple nodular goitre.
  • patients who are fit for surgery.

You may not qualify if:

  • children (male or female)
  • patients with malignant or recurrent goitre
  • patients who are unfit for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • Agarwal G, Aggarwal V. Is total thyroidectomy the surgical procedure of choice for benign multinodular goiter? An evidence-based review. World J Surg. 2008 Jul;32(7):1313-24. doi: 10.1007/s00268-008-9579-8.

    PMID: 18449595BACKGROUND

  • Tominaga Y, Uchida K, Haba T, Katayama A, Sato T, Hibi Y, Numano M, Tanaka Y, Inagaki H, Watanabe I, Hachisuka T, Takagi H. More than 1,000 cases of total parathyroidectomy with forearm autograft for renal hyperparathyroidism. Am J Kidney Dis. 2001 Oct;38(4 Suppl 1):S168-71. doi: 10.1053/ajkd.2001.27432.

    PMID: 11576947BACKGROUND

  • Wu Q, Zhang M, Qin Y, Jiang R, Chen H, Xu X, Yang T, Jiang K, Miao Y. Systematic review and meta-analysis of islet autotransplantation after total pancreatectomy in chronic pancreatitis patients. Endocr J. 2015;62(3):227-34. doi: 10.1507/endocrj.EJ14-0510. Epub 2015 Jan 7.

    PMID: 25735805BACKGROUND

  • Papaziogas B, Antoniadis A, Lazaridis Ch, Makris J, Kotakidou R, Paraskevas G, Papaziogas T. Functional capacity of the thyroid autograft: an experimental study. J Surg Res. 2002 Apr;103(2):223-7. doi: 10.1006/jsre.2001.6348.

    PMID: 11922738BACKGROUND

  • Shimizu K, Kumita S, Kitamura Y, Nagahama M, Kitagawa W, Akasu H, Oshina T, Kumasaki T, Tanaka S. Trial of autotransplantation of cryopreserved thyroid tissue for postoperative hypothyroidism in patients with Graves' disease. J Am Coll Surg. 2002 Jan;194(1):14-22. doi: 10.1016/s1072-7515(01)01115-2.

    PMID: 11800336BACKGROUND

  • Al-Samarrai AY, Crankson SJ, Al-Jobori A. Autotransplantation of lingual thyroid into the neck. Br J Surg. 1988 Mar;75(3):287. doi: 10.1002/bjs.1800750333. No abstract available.

    PMID: 3349341BACKGROUND

  • Swan H, Jenkins D, Schemmel J. Thyroid autograft. A 12-year follow-up. Arch Surg. 1967 Jun;94(6):817-20. doi: 10.1001/archsurg.1967.01330120071014. No abstract available.

    PMID: 4226078BACKGROUND

  • Mohsen AA, Nada AA, Ibrahim MY, Ghaleb AH, Abou-Gabal MA, Mohsen AA, Wassef AT. Technique and outcome of autotransplanting thyroid tissue after total thyroidectomy for simple multinodular goiters. Asian J Surg. 2017 Jan;40(1):17-22. doi: 10.1016/j.asjsur.2015.05.007. Epub 2015 Aug 31.

    PMID: 26337375BACKGROUND

  • Okamoto T, Fujimoto Y, Obara T, Ito Y, Kodama T, Kusakabe K. Trial of thyroid autotransplantation in patients with Graves' disease whose remnant thyroid has unintentionally been made too small at subtotal thyroidectomy. Endocrinol Jpn. 1990 Feb;37(1):95-101. doi: 10.1507/endocrj1954.37.95.

    PMID: 2384054BACKGROUND

  • Roy PG, Saund MS, Thusoo TK, Roy D, Sankar R. Fate of human thyroid tissue autotransplants. Surg Today. 2003;33(8):571-6. doi: 10.1007/s00595-003-2557-8.

    PMID: 12884093BACKGROUND

  • Sheverdin IuP. [The results of a 15-year observation of patients with an autotransplant of thyroid gland fragments performed to prevent postoperative hypothyroidism]. Vestn Khir Im I I Grek. 1992 Feb;148(2):152-6. Russian.

    PMID: 8594711BACKGROUND

  • Ozdemir D, Cuhaci FN, Ozdemir E, Aydin C, Ersoy R, Turkolmez S, Cakir B. The role of postoperative Tc-99m pertechnetate scintigraphy in estimation of remnant mass and prediction of successful ablation in patients with differentiated thyroid cancer. Nucl Med Commun. 2016 Jun;37(6):640-5. doi: 10.1097/MNM.0000000000000492.

    PMID: 26895488BACKGROUND

  • Uzzan B, Campos J, Cucherat M, Nony P, Boissel JP, Perret GY. Effects on bone mass of long term treatment with thyroid hormones: a meta-analysis. J Clin Endocrinol Metab. 1996 Dec;81(12):4278-89. doi: 10.1210/jcem.81.12.8954028.

    PMID: 8954028BACKGROUND

  • Katna R, Kalyani N, Deshpande A; Mumbai Oncology Group - Head and Neck. Free thyroid transfer to anterolateral thigh for prevention of radiation induced hypothyroidism: An initial experience. Am J Otolaryngol. 2019 Mar-Apr;40(2):160-163. doi: 10.1016/j.amjoto.2018.12.013. Epub 2018 Dec 21.

    PMID: 30594401RESULT

MeSH Terms

Conditions

Thyroid Diseases

Interventions

Hormones

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Abdullah Badawy, professor

    general surgery professor

    STUDY DIRECTOR

  • Ashraf Helmy, professor

    general surgery professor

    STUDY CHAIR

  • Mohamed M Saad Elshafey, professor

    general surgery professor

    STUDY CHAIR

  • Mohamed A Hassan, resident

    resident physician at general surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed A Hassan

CONTACT

01023858185mouhmed.ahmed@gmail.com

Abdullah Badawy, professor

CONTACT

01001861127badawy@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident surgeon

Study Record Dates

First Submitted

December 22, 2020

First Posted

December 28, 2020

Study Start

January 1, 2022

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

January 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share