Total Versus Subtotal Thyroidectomy in Graves' Disease At AUH

Thyroid Goiter Clinical Trial

Official title:

Total Versus Subtotal Thyroidectomy in Graves' Disease : A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04577664
• Other study ID #: Thyroid surgery
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2020
• Est. completion date: December 2021

Study information

• Verified date: October 2020
• Source: Assiut University
• Contact: ahmed nasr ahmed, resident doctor
• Phone: +201064594779
• Email: zorakovic11[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main aim of work is to compare between subtotal and total thyroidectomy intra and postoperatively to identify which technique is better for patient of graves disease

Description:

Graves' disease is an autoimmune disease that affects the thyroid gland[1] and it's the most common cause of hyperthyroidism. [2] Treatment of Graves' disease includes antithyroid drugs ; radioiodine ; and thyroidectomy . patients with Graves' hyperthyroidism can be treated with any of these treatment options. There is a wide geographic variation in the choice of therapy.[3] Medical treatment with antithyroid drugs is often accepted as first-choice modality in Europe, followed by radioiodine in case of recurrence. Although surgery offers the advantage of quick control and low morbidity in experienced hands, it is infrequently recommended as initial treatment. Therapy with radioiodine is the most common treatment in the United States, while antithyroid drugs and/or thyroidectomy are used more often in Europe, Japan, and most of the rest of the world.recent literature shows that the relapse rate was the highest among patients who received antithyroid drugs (40%) as compared to those who received radioiodine (21%) or Surgery (5). [4] Two different surgical techniques are used for the treatment of Graves' hyperthyroidism: a total thyroidectomy (TT) in which the entire gland is removed and a subtotal thyroidectomy (STT) , in which most of the gland is removed leaving a small unilateral or bilateral remnant in situ about 4-5 grams. Although thyroidectomy has been broadly considered as a viable alternative theapy for patients with Graves' disease , the resection extent and remnant size of thyroid gland remains controversial.[6] Although total thyroidectomy has a lower recurrence rate it has raised a concern that a more radical operation would increase the complications.[7] we intend to perform this analysis based on the published literatures of randomized controlled trials to evaluate the specific risks of thyroid surgery including recurrent hyperthyroididm , post-operative bleeding , recurrent laryngeal nerve injury , hypoparathyroidism and opthalmopathy progression.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients diagnosed clinically, biochemically and immunologically with Graves' disease who will undergo thyroidectomy at general surgery department in AUH.

Exclusion Criteria:

• 1- previous thyroid or parathyroid surgery.

• 2- recurrent hyperthyroidism after radioiodine therapy.

• 3- preoperative recurrent laryngeal nerve palsy.

• 4- patients unfit for operation.

• 5- inability to comply with the follow-up protocol.

• 6- suspicious thyroid nodules.

Related Conditions & MeSH terms

• Goiter
• Graves Disease
• Thyroid Goiter

Intervention

Procedure:
• total thyroidectomy
a total thyroidectomy (TT) in which the entire gland is removed
• subtotal thyroidectomy
subtotal thyroidectomy (STT) , in which most of the gland is removed leaving a small unilateral or bilateral remnant in situ about 4-5 grams.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Maurer E, Maschuw K, Reuss A, Zieren HU, Zielke A, Goretzki P, Simon D, Dotzenrath C, Steinmüller T, Jähne J, Kemen M, Coerper S, Leister I, Nies C, Hartel M, Türler A, Holzer K, Agha A, Knoop M, Musholt T, Aminossadati B, Bartsch DK. Total Versus Near-total Thyroidectomy in Graves Disease: Results of the Randomized Controlled Multicenter TONIG-trial. Ann Surg. 2019 Nov;270(5):755-761. doi: 10.1097/SLA.0000000000003528. — View Citation

Sugino K, Nagahama M, Kitagawa W, Ohkuwa K, Uruno T, Matsuzu K, Suzuki A, Tomoda C, Y Hames K, Akaishi J, Masaki C, Ogimi Y, Yabuta T, Ito K. Change of surgical strategy for Graves' disease from subtotal thyroidectomy to total thyroidectomy: a single institutional experience. Endocr J. 2019 Feb 28;66(2):181-186. doi: 10.1507/endocrj.EJ18-0324. Epub 2018 Dec 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison between total thyroidectomy vs subtotal thyroidectomy in graves' disease	Prevlance of recurrent hyperthyroidism	baseline
Secondary	comparison between total thyroidectomy vs subtotal thyroidectomy in graves' disease	Postoperative hypocalcemia and hypoparathyroidism.	baseline

External Links

•   graves disease
•   managment of graves' disease