ThyroidNCT01408368
Subtotal Versus Total Thyroidectomy for Graves' Disease
A study testing Bilateral subtotal thyroidectomy and Total thyroidectomy in people with Thyroid and Goiter, run by Jagiellonian University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Bilateral subtotal thyroidectomy and Total thyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2000to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery
Krakow, 31-202
About this study
Official title: Five-year Follow up of a Randomized Clinical Trial of Bilateral Subtotal Thyroidectomy Versus Total Thyroidectomy for Graves' Disease.
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.
Read the 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.
- Being tested
- Bilateral subtotal thyroidectomy, Total thyroidectomy
- Keywords
- Graves' disease, total thyroidectomy, bilateral subtotal thyroidectomy, Graves' ophthalmopathy, morbidity rate
- Medical subject headings
- Thyroid Diseases, Goiter, Graves Disease, Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral subtotal thyroidectomyProcedure or surgery
Also called BST
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).
Total thyroidectomyProcedure or surgery
Also called TT
The intervention consisted of total extracapsular thyroidectomy.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral subtotal thyroidectomy | Active comparator | Not described Receives: Procedure: Bilateral subtotal thyroidectomy |
| Total thyroidectomy | Experimental | Not described Receives: Procedure: Total thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term control of Graves' disease
Recurrence rate of hyperthyroidism and change in Graves' ophthalmopathy
Measured: up to 60 months postoperatively
Secondary outcomes (1)
Morbidity rate
recurrent laryngeal nerve injury and hypoparathyroidism
Measured: up to 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startJan 2000
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ThyroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Investigators
- Marcin Barczynski, MD, PhD, Principal investigator, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408368
- Sponsor's protocol ID
- BBN/501/ZKL/67/L
- Status last verified
- Aug 2011
- First submitted
- 2 Aug 2011
- Last updated
- 3 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20174803Stalberg 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.
PubMed 18327526Bartalena 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.
PubMed 21190983Wilhelm 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.
PubMed 20033406Barakate 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.
PubMed 12028087Chi 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.
PubMed 15650802Witte 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.
PubMed 11038198Barczynski 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.
PubMed 22287122
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five-year Follow up of a Randomized Clinical Trial of Bilateral Subtotal Thyroidectomy Versus Total Thyroidectomy for Graves' Disease.
- ClinicalTrials.gov ID
- NCT01408368
- Acronym / sponsor ID
- BBN/501/ZKL/67/L
- Keywords
- Graves' disease, total thyroidectomy, bilateral subtotal thyroidectomy, Graves' ophthalmopathy, morbidity rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral subtotal thyroidectomy | Active comparator | Procedure: Bilateral subtotal thyroidectomy |
| Total thyroidectomy | Experimental | Procedure: Total thyroidectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral subtotal thyroidectomyAlso: BSTThe intervention consisted of bilateral subtotal thyroidectomy (leaving on both sides of the neck thyroid stumps of approximately 2 g of normal remnant tissue each). | Procedure or surgery | Bilateral subtotal thyroidectomy |
| Total thyroidectomyAlso: TTThe intervention consisted of total extracapsular thyroidectomy. | Procedure or surgery | Total thyroidectomy |
Primary outcome
Long-term control of Graves' disease
Time frame: up to 60 months postoperatively
Recurrence rate of hyperthyroidism and change in Graves' ophthalmopathy
1 secondary outcome
Morbidity rate
Time frame: up to 12 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2011.
- Background: PubMed 20174803Barczynski 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.
- Background: PubMed 18327526Stalberg 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.
- Background: PubMed 21190983Bartalena 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.
- Background: PubMed 20033406Wilhelm 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.
- Background: PubMed 12028087Barakate 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.
- Background: PubMed 15650802Chi 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.
- Background: PubMed 11038198Witte 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.
- Derived from this study: PubMed 22287122Barczynski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcin Barczynski, MD, PhD principal investigator
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral subtotal thyroidectomy and Total thyroidectomy in people with Thyroid and Goiter, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term control of Graves' disease (time frame: up to 60 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01408368, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2011.