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Subtotal Versus Total Thyroidectomy for Graves' Disease

Primary Purpose

Thyroid, Goiter

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Bilateral subtotal thyroidectomy
Total thyroidectomy
Sponsored by
Jagiellonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid focused on measuring Graves' disease, total thyroidectomy, bilateral subtotal thyroidectomy, Graves' ophthalmopathy, morbidity rate

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • planned thyroid surgery for clinically, biochemically and immunologically diagnosed Graves' disease in patients with mild active ophthalmopathy and the posterior aspects of both thyroid lobes appearing normal on ultrasound of the neck.

Exclusion Criteria:

  • previous thyroid or parathyroid surgery,
  • recurrent hyperthyroidism after radioiodine ablation,
  • history of Graves' disease longer than 24 months,
  • thyroid nodules within the posterior aspect/s of thyroid lobe/s,
  • suspicion of thyroid cancer,
  • inactive Graves' ophthalmopathy,
  • moderate to severe active Graves' ophthalmopathy,
  • preoperative recurrent laryngeal nerve palsy,
  • pregnancy or lactation,
  • age < 18 years, or > 65 years,
  • ASA 4 grade (American Society of Anaesthesiology),
  • inability to comply with the follow-up protocol.

Sites / Locations

  • Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Bilateral subtotal thyroidectomy

Total thyroidectomy

Arm Description

Outcomes

Primary Outcome Measures

Long-term control of Graves' disease
Recurrence rate of hyperthyroidism and change in Graves' ophthalmopathy

Secondary Outcome Measures

Morbidity rate
recurrent laryngeal nerve injury and hypoparathyroidism

Full Information

First Posted
August 2, 2011
Last Updated
August 2, 2011
Sponsor
Jagiellonian University
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1. Study Identification

Unique Protocol Identification Number
NCT01408368
Brief Title
Subtotal Versus Total Thyroidectomy for Graves' Disease
Official Title
Five-year Follow up of a Randomized Clinical Trial of Bilateral Subtotal Thyroidectomy Versus Total Thyroidectomy for Graves' Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Jagiellonian University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The extent of thyroid resection in Graves' disease remains controversial. The aim of this study was to evaluate long-term results of bilateral subtotal thyroidectomy versus total thyroidectomy in patients with Graves' ophthalmopathy.
Detailed Description
Graves' disease was first described in 1835. It is an autoimmune disorder caused by antibodies which bind to thyroid-stimulating hormone (TSH) receptors on the thyroid cell membrane. The overt clinical manifestation of this disease is usually characterised by presence of hyperthyroidism, thyroid associated ophthalmopathy and thyroid dermopathy. Treatment alternatives of Graves' disease include antithyroid medication, radioiodine therapy or thyroidectomy. The antithyroid medication is often used as the initial treatment for patients with newly diagnosed Graves disease in much of the world including Europe, Japan and South America. However, the use of radioiodine is the most common first-line treatment modality in the United States. Thyroidectomy should be considered in special circumstances such as in children and young adults, pregnant women, in the setting of ophthalmopathy, in the presence of thyroid nodules or big goitre, particularly when compressive symptoms, or substernal thyroid extension is diagnosed, as well as in cases of failed hyperthyroidism remission after antithyroid medication in patients refusing possible radioiodine treatment. The surgical management of Graves' disease remains controversial. Some authors support total thyroidectomy while others prefer various subtotal procedures. Most low-volume surgeons avoid performing total thyroidectomies for Graves' disease owing to the assumed higher complication rates. On the other hand, an increasing number of total thyroidectomies are currently performed in high-volume endocrine surgery units, and the indications for this procedure include not only high-risk thyroid cancer, but also Graves's disease and multinodular goiter. It has been shown that total thyroidectomy for Graves' disease lowers to almost zero the disease recurrence rate. However, other issues like unclear benefit for natural course of Graves' ophthalmopathy balanced against assumed higher risk of morbidity following more radical thyroid resections need to be clarified. We hypothesized that total thyroidectomy is superior to bilateral subtotal thyroidectomy for long-term control of Graves' disease. The aim of this study was to evaluate long-term results of bilateral subtotal thyroidectomy versus total thyroidectomy in patients with mild and active Graves' ophthalmopathy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid, Goiter
Keywords
Graves' disease, total thyroidectomy, bilateral subtotal thyroidectomy, Graves' ophthalmopathy, morbidity rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilateral subtotal thyroidectomy
Arm Type
Active Comparator
Arm Title
Total thyroidectomy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Bilateral subtotal thyroidectomy
Other Intervention Name(s)
BST
Intervention Description
The intervention consisted of bilateral subtotal thyroidectomy (leaving on both sides of the neck thyroid stumps of approximately 2 g of normal remnant tissue each).
Intervention Type
Procedure
Intervention Name(s)
Total thyroidectomy
Other Intervention Name(s)
TT
Intervention Description
The intervention consisted of total extracapsular thyroidectomy.
Primary Outcome Measure Information:
Title
Long-term control of Graves' disease
Description
Recurrence rate of hyperthyroidism and change in Graves' ophthalmopathy
Time Frame
up to 60 months postoperatively
Secondary Outcome Measure Information:
Title
Morbidity rate
Description
recurrent laryngeal nerve injury and hypoparathyroidism
Time Frame
up to 12 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: planned thyroid surgery for clinically, biochemically and immunologically diagnosed Graves' disease in patients with mild active ophthalmopathy and the posterior aspects of both thyroid lobes appearing normal on ultrasound of the neck. Exclusion Criteria: previous thyroid or parathyroid surgery, recurrent hyperthyroidism after radioiodine ablation, history of Graves' disease longer than 24 months, thyroid nodules within the posterior aspect/s of thyroid lobe/s, suspicion of thyroid cancer, inactive Graves' ophthalmopathy, moderate to severe active Graves' ophthalmopathy, preoperative recurrent laryngeal nerve palsy, pregnancy or lactation, age < 18 years, or > 65 years, ASA 4 grade (American Society of Anaesthesiology), inability to comply with the follow-up protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcin Barczynski, MD, PhD
Organizational Affiliation
Jagiellonian University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery
City
Krakow
ZIP/Postal Code
31-202
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20174803
Citation
Barczynski M, Konturek A, Hubalewska-Dydejczyk A, Golkowski F, Cichon S, Nowak W. Five-year follow-up of a randomized clinical trial of total thyroidectomy versus Dunhill operation versus bilateral subtotal thyroidectomy for multinodular nontoxic goiter. World J Surg. 2010 Jun;34(6):1203-13. doi: 10.1007/s00268-010-0491-7.
Results Reference
background
PubMed Identifier
18327526
Citation
Stalberg P, Svensson A, Hessman O, Akerstrom G, Hellman P. Surgical treatment of Graves' disease: evidence-based approach. World J Surg. 2008 Jul;32(7):1269-77. doi: 10.1007/s00268-008-9497-9.
Results Reference
background
PubMed Identifier
21190983
Citation
Bartalena L. The dilemma of how to manage Graves' hyperthyroidism in patients with associated orbitopathy. J Clin Endocrinol Metab. 2011 Mar;96(3):592-9. doi: 10.1210/jc.2010-2329. Epub 2010 Dec 29.
Results Reference
background
PubMed Identifier
20033406
Citation
Wilhelm SM, McHenry CR. Total thyroidectomy is superior to subtotal thyroidectomy for management of Graves' disease in the United States. World J Surg. 2010 Jun;34(6):1261-4. doi: 10.1007/s00268-009-0337-3.
Results Reference
background
PubMed Identifier
12028087
Citation
Barakate MS, Agarwal G, Reeve TS, Barraclough B, Robinson B, Delbridge LW. Total thyroidectomy is now the preferred option for the surgical management of Graves' disease. ANZ J Surg. 2002 May;72(5):321-4. doi: 10.1046/j.1445-2197.2002.02400.x.
Results Reference
background
PubMed Identifier
15650802
Citation
Chi SY, Hsei KC, Sheen-Chen SM, Chou FF. A prospective randomized comparison of bilateral subtotal thyroidectomy versus unilateral total and contralateral subtotal thyroidectomy for graves' disease. World J Surg. 2005 Feb;29(2):160-3. doi: 10.1007/s00268-004-7529-7. Epub 2005 Jan 18.
Results Reference
background
PubMed Identifier
11038198
Citation
Witte J, Goretzki PE, Dotzenrath C, Simon D, Felis P, Neubauer M, Roher HD. Surgery for Graves' disease: total versus subtotal thyroidectomy-results of a prospective randomized trial. World J Surg. 2000 Nov;24(11):1303-11. doi: 10.1007/s002680010216.
Results Reference
background
PubMed Identifier
22287122
Citation
Barczynski M, Konturek A, Hubalewska-Dydejczyk A, Golkowski F, Nowak W. Randomized clinical trial of bilateral subtotal thyroidectomy versus total thyroidectomy for Graves' disease with a 5-year follow-up. Br J Surg. 2012 Apr;99(4):515-22. doi: 10.1002/bjs.8660. Epub 2012 Jan 27.
Results Reference
derived

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Subtotal Versus Total Thyroidectomy for Graves' Disease

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