Subtotal Versus Total Thyroidectomy for Graves' Disease

NCT01408368 | Completed DMC

• 1 other identifier: BBN/501/ZKL/67/L
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid; Goiter

Keywords

Graves' disease; total thyroidectomy; bilateral subtotal thyroidectomy; Graves' ophthalmopathy; morbidity rate

Outcome Measures

Primary Outcomes (1)

• Long-term control of Graves' disease

  Recurrence rate of hyperthyroidism and change in Graves' ophthalmopathy

  up to 60 months postoperatively

Secondary Outcomes (1)

• Morbidity rate

  up to 12 months postoperatively

Study Arms (2)

Bilateral subtotal thyroidectomy

ACTIVE COMPARATOR

Procedure: Bilateral subtotal thyroidectomy

Total thyroidectomy

EXPERIMENTAL

Procedure: Total thyroidectomy

Interventions

Bilateral subtotal thyroidectomy PROCEDURE

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).

Also known as: BST

Bilateral subtotal thyroidectomy

Total thyroidectomy PROCEDURE

The intervention consisted of total extracapsular thyroidectomy.

Also known as: TT

Total thyroidectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

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

Krakow, 31-202, Poland

Location

Related Publications (8)

• 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.

  PMID: 20174803 BACKGROUND

• 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.

  PMID: 18327526 BACKGROUND

• 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.

  PMID: 21190983 BACKGROUND

• 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.

  PMID: 20033406 BACKGROUND

• 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.

  PMID: 12028087 BACKGROUND

• 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.

  PMID: 15650802 BACKGROUND

• 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.

  PMID: 11038198 BACKGROUND

• 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.

  PMID: 22287122 DERIVED

MeSH Terms

Conditions

Thyroid Diseases; Goiter; Graves Disease; Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Exophthalmos; Orbital Diseases; Eye Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Marcin Barczynski, MD, PhD

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 3, 2011
• Study Start: January 1, 2000
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: August 3, 2011

Record last verified: 2011-08

Locations

PL (1)