Total Versus Subtotal Thyroidectomy in Graves' Disease At AUH
1 other identifier
interventional
60
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedOctober 8, 2020
October 1, 2020
1 year
July 28, 2020
October 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
comparison between total thyroidectomy vs subtotal thyroidectomy in graves' disease
Prevlance of recurrent hyperthyroidism
baseline
Secondary Outcomes (1)
comparison between total thyroidectomy vs subtotal thyroidectomy in graves' disease
baseline
Study Arms (2)
TT group
ACTIVE COMPARATORST group
ACTIVE COMPARATORInterventions
subtotal thyroidectomy (STT) , in which most of the gland is removed leaving a small unilateral or bilateral remnant in situ about 4-5 grams.
Eligibility Criteria
You may qualify if:
- patients diagnosed clinically, biochemically and immunologically with Graves' disease who will undergo thyroidectomy at general surgery department in AUH.
You may not qualify if:
- previous thyroid or parathyroid surgery.
- recurrent hyperthyroidism after radioiodine therapy.
- preoperative recurrent laryngeal nerve palsy.
- patients unfit for operation.
- inability to comply with the follow-up protocol.
- suspicious thyroid nodules.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 30568070BACKGROUNDMaurer 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.
PMID: 31634179BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident doctor at general surgery department
Study Record Dates
First Submitted
July 28, 2020
First Posted
October 8, 2020
Study Start
November 1, 2020
Primary Completion
November 1, 2021
Study Completion
December 1, 2021
Last Updated
October 8, 2020
Record last verified: 2020-10