GoiterNCT00946894
Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter
A study testing Total thyroidectomy, Dunhill operation and Bilateral subtotal thyroidectomy in people with Goiter, run by Jagiellonian University at 1 site in Poland.
Trial summary
The aim of this three-arm randomized study was to evaluate results of different thyroid resection modes among patients with bilateral multinodular non-toxic goiter, with special emphasis put on recurrence rate and morbidity rate, in a 5-year follow-up. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Goiter
- What is being tested?
- Total thyroidectomy, Dunhill operation and Bilateral subtotal thyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2000to Dec 2008
- 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
- a bilateral non-toxic multinodular goiter with normal appearing on ultrasound of the neck posterior aspects of both thyroid lobes.
Who cannot join
- multinodular goiter involving posterior aspect/s of thyroid lobe/s,
- suspicion of thyroid cancer,
- previous thyroid surgery,
- thyroiditis,
- subclinical or clinically overt hypothyroidism or hyperthyroidism,
- pregnancy or lactation,
Show all 9Show fewer
- age < 18 years or > 65 years,
- ASA 4 grade (American Society of Anesthesiology),
- 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 Total Thyroidectomy Versus Dunhill Operation Versus Bilateral Subtotal Thyroidectomy for Multinodular Non-toxic Goiter.
The aim of this three-arm randomized study was to evaluate results of different thyroid resection modes among patients with bilateral multinodular non-toxic goiter, with special emphasis put on recurrence rate and morbidity rate, in a 5-year follow-up.
Read the detailed description
The extent of thyroid resection in bilateral multinodular non-toxic goiter remains controversial. Surgeons still continue to debate whether the potential benefits of total thyroidectomy outweigh the potential complications. Most low-volume surgeons avoid to perform total thyroidectomy owing to the possible complications such as permanent recurrent laryngeal nerve palsy and permanent hypoparathyroidism. On the other hand, the increasing number of total thyroidectomies are currently performed in high-volume endocrine surgery units, and the indication for this procedure include thyroid cancer, Graves disease and multinodular goiter. Recently there has been increasing acceptance for performing total thyroidectomy for bilateral multinodular non-toxic goiter as it removes the disease process completely, lowers local recurrence rate and avoids the substantial risk of reoperative surgery, and involves only a minimal risk of morbidity. This common perception is based largely on single-institution retrospective data, a few multi-institutional retrospective experiences, and only a few prospective randomized studies comparing the outcomes of total vs. subtotal thyroidectomy.
- Conditions
- Goiter
- Being tested
- Total thyroidectomy, Dunhill operation, Bilateral subtotal thyroidectomy
- Keywords
- Total thyroidectomy, Subtotal thyroidectomy, Dunhill operation, Recurrent nodular goiter, Completion thyroidectomy, Recurrent laryngeal nerve palsy, Hypoparathyroidism following thyroidectomy, Recurrent goiter
- Medical subject headings
- Goiter, Goiter, Nodular, Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total thyroidectomyProcedure or surgery
Also called TT
Total thyroidectomy
Dunhill operationProcedure or surgery
Also called DO
Unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy
Bilateral subtotal thyroidectomyProcedure or surgery
Also called BST
Bilateral subtotal thyroidectomy
| Study group | Role | What they receive |
|---|---|---|
| Total thyroidectomy | Experimental | Patients who underwent total thyroidectomy Receives: Procedure: Total thyroidectomy |
| Dunhill operation | Experimental | Patients who underwent unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy Receives: Procedure: Dunhill operation |
| Bilateral subtotal thyroidectomy | Active comparator | Patients who underwent bilateral subtotal thyroidectomy Receives: Procedure: Bilateral subtotal thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure was prevalence of recurrent goiter and need for redo surgery.
Measured: at 12, 24, 36, 48 and 60 months after surgery
Secondary outcomes (1)
Secondary outcome measure was postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury).
Measured: at 3, 6, 9, 12, 24, 36, 48 and 60 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startJan 2000
- Primary completionDec 2003
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for GoiterStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Investigators
- Marcin Barczynski, MD, PhD, Principal investigator, Jagiellonian University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946894
- Sponsor's protocol ID
- BBN/501/ZKL/68/L
- Status last verified
- Jul 2009
- First submitted
- 23 Jul 2009
- Last updated
- 27 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Snook KL, Stalberg PL, Sidhu SB, Sywak MS, Edhouse P, Delbridge L. Recurrence after total thyroidectomy for benign multinodular goiter. World J Surg. 2007 Mar;31(3):593-8; discussion 599-600. doi: 10.1007/s00268-006-0135-0.
PubMed 17308855Wheeler MH. Total thyroidectomy for benign thyroid disease. Lancet. 1998 May 23;351(9115):1526-7. doi: 10.1016/S0140-6736(05)61116-6. No abstract available.
PubMed 10326531Ozbas S, Kocak S, Aydintug S, Cakmak A, Demirkiran MA, Wishart GC. Comparison of the complications of subtotal, near total and total thyroidectomy in the surgical management of multinodular goitre. Endocr J. 2005 Apr;52(2):199-205. doi: 10.1507/endocrj.52.199.
PubMed 15863948Moalem J, Suh I, Duh QY. Treatment and prevention of recurrence of multinodular goiter: an evidence-based review of the literature. World J Surg. 2008 Jul;32(7):1301-12. doi: 10.1007/s00268-008-9477-0.
PubMed 18305998Tezelman S, Borucu I, Senyurek Giles Y, Tunca F, Terzioglu T. The change in surgical practice from subtotal to near-total or total thyroidectomy in the treatment of patients with benign multinodular goiter. World J Surg. 2009 Mar;33(3):400-5. doi: 10.1007/s00268-008-9808-1.
PubMed 18958517Agarwal G, Aggarwal V. Is total thyroidectomy the surgical procedure of choice for benign multinodular goiter? An evidence-based review. World J Surg. 2008 Jul;32(7):1313-24. doi: 10.1007/s00268-008-9579-8.
PubMed 18449595Phitayakorn R, McHenry CR. Follow-up after surgery for benign nodular thyroid disease: evidence-based approach. World J Surg. 2008 Jul;32(7):1374-84. doi: 10.1007/s00268-008-9487-y.
PubMed 18311576Barczynski M, Konturek A, Cichon S. Randomized clinical trial of visualization versus neuromonitoring of recurrent laryngeal nerves during thyroidectomy. Br J Surg. 2009 Mar;96(3):240-6. doi: 10.1002/bjs.6417.
PubMed 19177420Barczynski M, Konturek A, Hubalewska-Dydejczyk A, Golkowski F, Nowak W. Ten-Year Follow-Up of a Randomized Clinical Trial of Total Thyroidectomy Versus Dunhill Operation Versus Bilateral Subtotal Thyroidectomy for Multinodular Non-toxic Goiter. World J Surg. 2018 Feb;42(2):384-392. doi: 10.1007/s00268-017-4230-1.
PubMed 28942461Barczynski 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 20174803
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2009. 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 Total Thyroidectomy Versus Dunhill Operation Versus Bilateral Subtotal Thyroidectomy for Multinodular Non-toxic Goiter.
- ClinicalTrials.gov ID
- NCT00946894
- Acronym / sponsor ID
- BBN/501/ZKL/68/L
- Conditions
- Goiter
- Keywords
- Total thyroidectomy, Subtotal thyroidectomy, Dunhill operation, Recurrent nodular goiter, Completion thyroidectomy, Recurrent laryngeal nerve palsy, Hypoparathyroidism following thyroidectomy, Recurrent goiter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 27 Jul 2009 (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 aim of this three-arm randomized study was to evaluate results of different thyroid resection modes among patients with bilateral multinodular non-toxic goiter, with special emphasis put on recurrence rate and morbidity rate, in a 5-year follow-up.
Detailed description
The extent of thyroid resection in bilateral multinodular non-toxic goiter remains controversial. Surgeons still continue to debate whether the potential benefits of total thyroidectomy outweigh the potential complications. Most low-volume surgeons avoid to perform total thyroidectomy owing to the possible complications such as permanent recurrent laryngeal nerve palsy and permanent hypoparathyroidism. On the other hand, the increasing number of total thyroidectomies are currently performed in high-volume endocrine surgery units, and the indication for this procedure include thyroid cancer, Graves disease and multinodular goiter. Recently there has been increasing acceptance for performing total thyroidectomy for bilateral multinodular non-toxic goiter as it removes the disease process completely, lowers local recurrence rate and avoids the substantial risk of reoperative surgery, and involves only a minimal risk of morbidity. This common perception is based largely on single-institution retrospective data, a few multi-institutional retrospective experiences, and only a few prospective randomized studies comparing the outcomes of total vs. subtotal thyroidectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Total thyroidectomy | Experimental | Procedure: Total thyroidectomyPatients who underwent total thyroidectomy |
| Dunhill operation | Experimental | Procedure: Dunhill operationPatients who underwent unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy |
| Bilateral subtotal thyroidectomy | Active comparator | Procedure: Bilateral subtotal thyroidectomyPatients who underwent bilateral subtotal 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)
- a bilateral non-toxic multinodular goiter with normal appearing on ultrasound of the neck posterior aspects of both thyroid lobes.
Key exclusion criteria (9 listed)
- multinodular goiter involving posterior aspect/s of thyroid lobe/s,
- suspicion of thyroid cancer,
- previous thyroid surgery,
- thyroiditis,
- subclinical or clinically overt hypothyroidism or hyperthyroidism,
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 |
|---|---|---|
| Total thyroidectomyAlso: TTTotal thyroidectomy | Procedure or surgery | Total thyroidectomy |
| Dunhill operationAlso: DOUnilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy | Procedure or surgery | Dunhill operation |
| Bilateral subtotal thyroidectomyAlso: BSTBilateral subtotal thyroidectomy | Procedure or surgery | Bilateral subtotal thyroidectomy |
Primary outcome
Primary outcome measure was prevalence of recurrent goiter and need for redo surgery.
Time frame: at 12, 24, 36, 48 and 60 months after surgery
1 secondary outcome
Secondary outcome measure was postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury).
Time frame: at 3, 6, 9, 12, 24, 36, 48 and 60 months after surgery
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 27 Jul 2009.
- Background: PubMed 17308855Snook KL, Stalberg PL, Sidhu SB, Sywak MS, Edhouse P, Delbridge L. Recurrence after total thyroidectomy for benign multinodular goiter. World J Surg. 2007 Mar;31(3):593-8; discussion 599-600. doi: 10.1007/s00268-006-0135-0.
- Background: PubMed 10326531Wheeler MH. Total thyroidectomy for benign thyroid disease. Lancet. 1998 May 23;351(9115):1526-7. doi: 10.1016/S0140-6736(05)61116-6. No abstract available.
- Background: PubMed 15863948Ozbas S, Kocak S, Aydintug S, Cakmak A, Demirkiran MA, Wishart GC. Comparison of the complications of subtotal, near total and total thyroidectomy in the surgical management of multinodular goitre. Endocr J. 2005 Apr;52(2):199-205. doi: 10.1507/endocrj.52.199.
- Background: PubMed 18305998Moalem J, Suh I, Duh QY. Treatment and prevention of recurrence of multinodular goiter: an evidence-based review of the literature. World J Surg. 2008 Jul;32(7):1301-12. doi: 10.1007/s00268-008-9477-0.
- Background: PubMed 18958517Tezelman S, Borucu I, Senyurek Giles Y, Tunca F, Terzioglu T. The change in surgical practice from subtotal to near-total or total thyroidectomy in the treatment of patients with benign multinodular goiter. World J Surg. 2009 Mar;33(3):400-5. doi: 10.1007/s00268-008-9808-1.
- Background: PubMed 18449595Agarwal G, Aggarwal V. Is total thyroidectomy the surgical procedure of choice for benign multinodular goiter? An evidence-based review. World J Surg. 2008 Jul;32(7):1313-24. doi: 10.1007/s00268-008-9579-8.
- Background: PubMed 18311576Phitayakorn R, McHenry CR. Follow-up after surgery for benign nodular thyroid disease: evidence-based approach. World J Surg. 2008 Jul;32(7):1374-84. doi: 10.1007/s00268-008-9487-y.
- Background: PubMed 19177420Barczynski M, Konturek A, Cichon S. Randomized clinical trial of visualization versus neuromonitoring of recurrent laryngeal nerves during thyroidectomy. Br J Surg. 2009 Mar;96(3):240-6. doi: 10.1002/bjs.6417.
- Derived from this study: PubMed 28942461Barczynski M, Konturek A, Hubalewska-Dydejczyk A, Golkowski F, Nowak W. Ten-Year Follow-Up of a Randomized Clinical Trial of Total Thyroidectomy Versus Dunhill Operation Versus Bilateral Subtotal Thyroidectomy for Multinodular Non-toxic Goiter. World J Surg. 2018 Feb;42(2):384-392. doi: 10.1007/s00268-017-4230-1.
- Derived from this study: 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.
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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 College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total thyroidectomy, Dunhill operation and Bilateral subtotal thyroidectomy in people with 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 9 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 27 Jul 2009. 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?
Primary outcome measure was prevalence of recurrent goiter and need for redo surgery. (time frame: at 12, 24, 36, 48 and 60 months after surgery). 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 NCT00946894, which also lists 10 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 27 Jul 2009.