Total Versus Subtotal Thyroidectomy in Graves' Disease At AUH

NCT ID: NCT04577664

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2021-12-31

Brief 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

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.

Conditions

Thyroid Goiter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TT group

Group Type: ACTIVE_COMPARATOR

total thyroidectomy

Intervention Type: PROCEDURE

a total thyroidectomy (TT) in which the entire gland is removed

ST group

Group Type: ACTIVE_COMPARATOR

subtotal thyroidectomy

Intervention Type: PROCEDURE

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

Interventions

total thyroidectomy

a total thyroidectomy (TT) in which the entire gland is removed

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Nasr

resident doctor at general surgery department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

ahmed nasr ahmed, resident doctor

Role: CONTACT

zorakovic11@gmail.com

+201064594779

hesham ali reyad, professor of general surgery

Role: CONTACT

heshamreyad@aun.edu.eg

+201005015757

References

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.

Reference Type: BACKGROUND

PMID: 30568070 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31634179 (View on PubMed)

Related Links

https://www.niddk.nih.gov/health-information/endocrine-diseases/graves-disease?dkrd=hispt0296

graves disease

Other Identifiers

Thyroid surgery

Identifier Type: -

Identifier Source: org_study_id