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Total Versus Subtotal Thyroidectomy in Graves' Disease At AUH

Primary Purpose

Thyroid Goiter

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
total thyroidectomy
subtotal thyroidectomy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Goiter

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    TT group

    ST group

    Arm Description

    Outcomes

    Primary Outcome Measures

    comparison between total thyroidectomy vs subtotal thyroidectomy in graves' disease
    Prevlance of recurrent hyperthyroidism

    Secondary Outcome Measures

    comparison between total thyroidectomy vs subtotal thyroidectomy in graves' disease
    Postoperative hypocalcemia and hypoparathyroidism.

    Full Information

    First Posted
    July 28, 2020
    Last Updated
    October 2, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04577664
    Brief Title
    Total Versus Subtotal Thyroidectomy in Graves' Disease At AUH
    Official Title
    Total Versus Subtotal Thyroidectomy in Graves' Disease : A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2020 (Anticipated)
    Primary Completion Date
    November 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid Goiter

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TT group
    Arm Type
    Active Comparator
    Arm Title
    ST group
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    total thyroidectomy
    Intervention Description
    a total thyroidectomy (TT) in which the entire gland is removed
    Intervention Type
    Procedure
    Intervention Name(s)
    subtotal thyroidectomy
    Intervention Description
    subtotal thyroidectomy (STT) , in which most of the gland is removed leaving a small unilateral or bilateral remnant in situ about 4-5 grams.
    Primary Outcome Measure Information:
    Title
    comparison between total thyroidectomy vs subtotal thyroidectomy in graves' disease
    Description
    Prevlance of recurrent hyperthyroidism
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    comparison between total thyroidectomy vs subtotal thyroidectomy in graves' disease
    Description
    Postoperative hypocalcemia and hypoparathyroidism.
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ahmed nasr ahmed, resident doctor
    Phone
    +201064594779
    Email
    zorakovic11@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    hesham ali reyad, professor of general surgery
    Phone
    +201005015757
    Email
    heshamreyad@aun.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30568070
    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.
    Results Reference
    background
    PubMed Identifier
    31634179
    Citation
    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.
    Results Reference
    background
    Links:
    URL
    https://www.niddk.nih.gov/health-information/endocrine-diseases/graves-disease?dkrd=hispt0296
    Description
    graves disease
    URL
    https://jamanetwork.com/journals/jama/article-abstract/2475467
    Description
    managment of graves' disease

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    Total Versus Subtotal Thyroidectomy in Graves' Disease At AUH

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