Recurrent GoiterNCT00941551
Thyroid Lobectomy With or Without Levothyroxine Treatment Postoperatively
An observational study of Recurrent Goiter, run by Jagiellonian University at 1 site in Poland.
Trial summary
The aim of this study was to compare the prevalence of recurrent nodular goiter in the contralateral thyroid lobe among patients after unilateral thyroid lobectomy for unilateral multinodular goiter receiving versus not receiving prophylactic levothyroxine treatment postoperatively in a five-year follow-up of a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Recurrent Goiter
- What is being tested?
- levothyroxine and no levothyroxine
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2000to Dec 2008
- Phase
- Observational
- 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
Study population: primary care clinic
Who may be able to join
- unilateral multinodular goiter with normal appearing on ultrasound of the neck contralateral thyroid lobe, in a patient in euthyroid state
Who cannot join
- bilateral multinodular goiter, enlargement of contralateral thyroid lobe (volume on ultrasound >10 ml), suspicion of thyroid cancer, previous thyroid surgery, thyroiditis, subclinical or clinically overt hypothyroidism or hyperthyroidism, pregnancy or lactation, age < 18 years or > 65 years, ASA 4 grade (American Society of Anesthesiology), and 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 Unilateral Thyroid Lobectomy With or Without Levothyroxine Treatment Postoperatively
The aim of this study was to compare the prevalence of recurrent nodular goiter in the contralateral thyroid lobe among patients after unilateral thyroid lobectomy for unilateral multinodular goiter receiving versus not receiving prophylactic levothyroxine treatment postoperatively in a five-year follow-up of a randomized study
Read the detailed description
It is commonly accepted that in patients with benign nodular thyroid disease who undergo operative therapy, surgical resection consists of lobectomy for patients with disease limited to one lobe. Contralateral disease is excluded in such cases by preoperative palpation, ultrasonography of the neck, and intraoperative palpation. On the other hand, the preferred operative procedure for bilateral nodular thyroid disease is total thyroidectomy. Such a treatment strategy minimizes the risk of development of recurrent disease and diminishes the risk of complications when reoperation for recurrent nodular thyroid disease becomes necessary. The recurrence rate for unilateral thyroidectomy of benign nodular goiter performed by expert surgeons has been reported to vary from 10% to 26%. Potential risk factors for recurrence of nodular goiter have been evaluated in many studies and include: young age at presentation, female gender, positive family history of goiter, long duration of symptoms, mutinodularity of thyroid disease, high volume of left thyroid tissue. However, most studies evaluating the incidence of recurrent nodular disease are retrospective, and it is difficult to determine whether the recurrence represents de novo nodule formation in a previously normal thyroid remnant or progression of residual disease left at initial operation.
It is well known fact, that most patients after thyroid lobectomy are euthyroid (60%-90%) and do not require thyroid hormone replacement therapy. However, it is an important question whether thyroid hormone administration postoperatively can prevent recurrent nodular thyroid disease in euthyroid hemithyroidectomized patients? The aim of the present randomized study was to compare the prevalence of recurrent nodular goiter in the contralateral thyroid lobe among patients after unilateral thyroid lobectomy for unilateral multinodular goiter (MNG) receiving versus not receiving prophylactic levothyroxine (LT4) treatment postoperatively in a five-year follow-up.
- Conditions
- Recurrent Goiter
- Being tested
- levothyroxine, no levothyroxine
- Keywords
- Thyroid lobectomy,, prophylactic levothyroxine treatment,, recurrent nodular goiter,, iodine deficiency,, long-term follow-up,, completion thyroidectomy
- Medical subject headings
- Goiter, Goiter, Nodular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levothyroxineDrug
Also called LT4(+)
levothyroxine 75-125 ug/day
no levothyroxineDrug
Also called LT4(-)
observation only without prophylactic levothyroxine
| Study group | Role | What they receive |
|---|---|---|
| Group A | receiving levothyroxine postoperatively Receives: Drug: levothyroxine | |
| Group B | not-receiving levothyroxine postoperatively Receives: Drug: no levothyroxine |
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 within the contralateral thyroid lobe
Measured: at 3, 6, 9, 12, 24, 36, 48 and 60 months postoperatively
Secondary outcomes (1)
Secondary outcome was the rate of the reoperation for the recurrent goiter
Measured: at 3, 6, 9, 12, 24, 36, 48 and 60 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 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 (6)Papers the sponsor has linked to this study.
- Other trials for Recurrent 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 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
- NCT00941551
- Sponsor's protocol ID
- BBN/501/ZKL/69/L
- Status last verified
- Jul 2009
- First submitted
- 16 Jul 2009
- Last updated
- 17 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Szybinski Z, Golkowski F, Buziak-Bereza M, Trofimiuk M, Przybylik-Mazurek E, Huszno B, Bandurska-Stankiewicz E, Bar-Andziak E, Dorant B, Kinalska I, Lewinski A, Klencki M, Rybakowa M, Sowinski J, Szewczyk L, Szponar L, Wasik R. Effectiveness of the iodine prophylaxis model adopted in Poland. J Endocrinol Invest. 2008 Apr;31(4):309-13. doi: 10.1007/BF03346363.
PubMed 18475048Bellantone R, Lombardi CP, Boscherini M, Raffaelli M, Tondolo V, Alesina PF, Corsello SM, Fintini D, Bossola M. Predictive factors for recurrence after thyroid lobectomy for unilateral non-toxic goiter in an endemic area: results of a multivariate analysis. Surgery. 2004 Dec;136(6):1247-51. doi: 10.1016/j.surg.2004.06.054.
PubMed 15657583Miccoli P, Antonelli A, Iacconi P, Alberti B, Gambuzza C, Baschieri L. Prospective, randomized, double-blind study about effectiveness of levothyroxine suppressive therapy in prevention of recurrence after operation: result at the third year of follow-up. Surgery. 1993 Dec;114(6):1097-101; discussion 1101-2.
PubMed 8256213Bistrup C, Nielsen JD, Gregersen G, Franch P. Preventive effect of levothyroxine in patients operated for non-toxic goitre: a randomized trial of one hundred patients with nine years follow-up. Clin Endocrinol (Oxf). 1994 Mar;40(3):323-7. doi: 10.1111/j.1365-2265.1994.tb03926.x.
PubMed 8187295Carella C, Mazziotti G, Rotondi M, Del Buono A, Zito G, Sorvillo F, Manganella G, Santini L, Amato G. Iodized salt improves the effectiveness of L-thyroxine therapy after surgery for nontoxic goitre: a prospective and randomized study. Clin Endocrinol (Oxf). 2002 Oct;57(4):507-13. doi: 10.1046/j.1365-2265.2002.01628.x.
PubMed 12354133Barczynski M, Golkowski F, Hubalewska-Dydejczyk A, Konturek A. Twenty-year follow-up of a randomized clinical trial of unilateral thyroid lobectomy with or without postoperative levothyroxine treatment. World J Surg. 2025 Jan;49(1):140-147. doi: 10.1002/wjs.12403. Epub 2024 Nov 15.
PubMed 39547954
Study at a glance
From the registry record, last updated by the sponsor on 17 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 Unilateral Thyroid Lobectomy With or Without Levothyroxine Treatment Postoperatively
- ClinicalTrials.gov ID
- NCT00941551
- Acronym / sponsor ID
- BBN/501/ZKL/69/L
- Conditions
- Recurrent Goiter
- Keywords
- Thyroid lobectomy,, prophylactic levothyroxine treatment,, recurrent nodular goiter,, iodine deficiency,, long-term follow-up,, completion thyroidectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 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
- 17 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 study was to compare the prevalence of recurrent nodular goiter in the contralateral thyroid lobe among patients after unilateral thyroid lobectomy for unilateral multinodular goiter receiving versus not receiving prophylactic levothyroxine treatment postoperatively in a five-year follow-up of a randomized study
Detailed description
It is commonly accepted that in patients with benign nodular thyroid disease who undergo operative therapy, surgical resection consists of lobectomy for patients with disease limited to one lobe. Contralateral disease is excluded in such cases by preoperative palpation, ultrasonography of the neck, and intraoperative palpation. On the other hand, the preferred operative procedure for bilateral nodular thyroid disease is total thyroidectomy. Such a treatment strategy minimizes the risk of development of recurrent disease and diminishes the risk of complications when reoperation for recurrent nodular thyroid disease becomes necessary. The recurrence rate for unilateral thyroidectomy of benign nodular goiter performed by expert surgeons has been reported to vary from 10% to 26%. Potential risk factors for recurrence of nodular goiter have been evaluated in many studies and include: young age at presentation, female gender, positive family history of goiter, long duration of symptoms, mutinodularity of thyroid disease, high volume of left thyroid tissue. However, most studies evaluating the incidence of recurrent nodular disease are retrospective, and it is difficult to determine whether the recurrence represents de novo nodule formation in a previously normal thyroid remnant or progression of residual disease left at initial operation.
It is well known fact, that most patients after thyroid lobectomy are euthyroid (60%-90%) and do not require thyroid hormone replacement therapy. However, it is an important question whether thyroid hormone administration postoperatively can prevent recurrent nodular thyroid disease in euthyroid hemithyroidectomized patients? The aim of the present randomized study was to compare the prevalence of recurrent nodular goiter in the contralateral thyroid lobe among patients after unilateral thyroid lobectomy for unilateral multinodular goiter (MNG) receiving versus not receiving prophylactic levothyroxine (LT4) treatment postoperatively in a five-year follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Drug: levothyroxinereceiving levothyroxine postoperatively |
| Group B | – | Drug: no levothyroxinenot-receiving levothyroxine postoperatively |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- unilateral multinodular goiter with normal appearing on ultrasound of the neck contralateral thyroid lobe, in a patient in euthyroid state
Key exclusion criteria (1 listed)
- bilateral multinodular goiter, enlargement of contralateral thyroid lobe (volume on ultrasound >10 ml), suspicion of thyroid cancer, previous thyroid surgery, thyroiditis, subclinical or clinically overt hypothyroidism or hyperthyroidism, pregnancy or lactation, age < 18 years or > 65 years, ASA 4 grade (American Society of Anesthesiology), and inability to comply with the follow-up protocol
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 |
|---|---|---|
| levothyroxineAlso: LT4(+)levothyroxine 75-125 ug/day | Drug | Group A |
| no levothyroxineAlso: LT4(-)observation only without prophylactic levothyroxine | Drug | Group B |
Primary outcome
Primary outcome measure was prevalence of recurrent goiter within the contralateral thyroid lobe
Time frame: at 3, 6, 9, 12, 24, 36, 48 and 60 months postoperatively
1 secondary outcome
Secondary outcome was the rate of the reoperation for the recurrent goiter
Time frame: at 3, 6, 9, 12, 24, 36, 48 and 60 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 17 Jul 2009.
- Background: PubMed 18475048Szybinski Z, Golkowski F, Buziak-Bereza M, Trofimiuk M, Przybylik-Mazurek E, Huszno B, Bandurska-Stankiewicz E, Bar-Andziak E, Dorant B, Kinalska I, Lewinski A, Klencki M, Rybakowa M, Sowinski J, Szewczyk L, Szponar L, Wasik R. Effectiveness of the iodine prophylaxis model adopted in Poland. J Endocrinol Invest. 2008 Apr;31(4):309-13. doi: 10.1007/BF03346363.
- Background: PubMed 15657583Bellantone R, Lombardi CP, Boscherini M, Raffaelli M, Tondolo V, Alesina PF, Corsello SM, Fintini D, Bossola M. Predictive factors for recurrence after thyroid lobectomy for unilateral non-toxic goiter in an endemic area: results of a multivariate analysis. Surgery. 2004 Dec;136(6):1247-51. doi: 10.1016/j.surg.2004.06.054.
- Background: PubMed 8256213Miccoli P, Antonelli A, Iacconi P, Alberti B, Gambuzza C, Baschieri L. Prospective, randomized, double-blind study about effectiveness of levothyroxine suppressive therapy in prevention of recurrence after operation: result at the third year of follow-up. Surgery. 1993 Dec;114(6):1097-101; discussion 1101-2.
- Background: PubMed 8187295Bistrup C, Nielsen JD, Gregersen G, Franch P. Preventive effect of levothyroxine in patients operated for non-toxic goitre: a randomized trial of one hundred patients with nine years follow-up. Clin Endocrinol (Oxf). 1994 Mar;40(3):323-7. doi: 10.1111/j.1365-2265.1994.tb03926.x.
- Background: PubMed 12354133Carella C, Mazziotti G, Rotondi M, Del Buono A, Zito G, Sorvillo F, Manganella G, Santini L, Amato G. Iodized salt improves the effectiveness of L-thyroxine therapy after surgery for nontoxic goitre: a prospective and randomized study. Clin Endocrinol (Oxf). 2002 Oct;57(4):507-13. doi: 10.1046/j.1365-2265.2002.01628.x.
- Derived from this study: PubMed 39547954Barczynski M, Golkowski F, Hubalewska-Dydejczyk A, Konturek A. Twenty-year follow-up of a randomized clinical trial of unilateral thyroid lobectomy with or without postoperative levothyroxine treatment. World J Surg. 2025 Jan;49(1):140-147. doi: 10.1002/wjs.12403. Epub 2024 Nov 15.
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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?
An observational study of Recurrent 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 1 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 17 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 within the contralateral thyroid lobe (time frame: at 3, 6, 9, 12, 24, 36, 48 and 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 NCT00941551, which also lists 6 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 17 Jul 2009.