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
About this trial
This is an interventional treatment trial for Thyroid Goiter
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.
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
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
Learn more about this trial
Total Versus Subtotal Thyroidectomy in Graves' Disease At AUH
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