Total Versus Subtotal Thyroidectomy in Graves' Disease At AUH

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

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

Study Overview

• Status: Unknown
• Conditions: Thyroid Goiter
• Intervention / Treatment: Procedure: total thyroidectomy; Procedure: subtotal thyroidectomy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TT group	Procedure: total thyroidectomy; a total thyroidectomy (TT) in which the entire gland is removed
Active Comparator: ST group	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison between total thyroidectomy vs subtotal thyroidectomy in graves' disease	Prevlance of recurrent hyperthyroidism	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison between total thyroidectomy vs subtotal thyroidectomy in graves' disease	Postoperative hypocalcemia and hypoparathyroidism.	baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• Maurer E, Maschuw K, Reuss A, Zieren HU, Zielke A, Goretzki P, Simon D, Dotzenrath C, Steinmuller T, Jahne J, Kemen M, Coerper S, Leister I, Nies C, Hartel M, Turler 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.

Helpful Links

• graves disease
• managment of graves' disease

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: October 2, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 2, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Eye Diseases; Endocrine System Diseases; Thyroid Diseases; Exophthalmos; Orbital Diseases; Hyperthyroidism; Goiter; Graves Disease
• Other Study ID Numbers: Thyroid surgery

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No