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Status unknownNCT04577664Updated Oct 8, 2020

Total Versus Subtotal Thyroidectomy in Graves' Disease At AUH

An interventional study of total thyroidectomy and subtotal thyroidectomy in Thyroid Goiter, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-08.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Thyroid Goiter

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03

In context

Goiter

66 studies on the registry are indexed under Goiter; 11 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 42 interventional studies indexed under Goiter.

Browse Goiter studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    TT group

    Procedure: total thyroidectomy

  • Active comparator
    ST group

    Procedure: subtotal thyroidectomy

Interventions

  • Proceduretotal thyroidectomy

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

  • Proceduresubtotal 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.

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What researchers measure

Primary outcomes

  1. comparison between total thyroidectomy vs subtotal thyroidectomy in graves' disease

    Prevlance of recurrent hyperthyroidism

    Time frame: baseline

Secondary outcomes

  1. comparison between total thyroidectomy vs subtotal thyroidectomy in graves' disease

    Postoperative hypocalcemia and hypoparathyroidism.

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 30568070 ↗
  • 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. PubMed 31634179 ↗

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04577664
Lead sponsor
Assiut University
Responsible party
Ahmed Nasr (resident doctor at general surgery department, Assiut University) — Principal investigator
First posted
Oct 8, 2020
Start date
Nov 2020 (estimated)
Primary completion
Nov 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Oct 8, 2020

Study contacts

ahmed nasr ahmed, resident doctor
Contact
zorakovic11@gmail.com
+201064594779
hesham ali reyad, professor of general surgery
Contact
heshamreyad@aun.edu.eg
+201005015757

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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