Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-06 @ 7:10 PM
Study NCT ID:
NCT00941551
Status:
COMPLETED
Last Update Posted:
2009-07-17
First Post:
2009-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thyroid Lobectomy With or Without Levothyroxine Treatment Postoperatively
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006042', 'term': 'Goiter'}, {'id': 'D006044', 'term': 'Goiter, Nodular'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013974', 'term': 'Thyroxine'}], 'ancestors': [{'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-16', 'studyFirstSubmitDate': '2009-07-16', 'studyFirstSubmitQcDate': '2009-07-16', 'lastUpdatePostDateStruct': {'date': '2009-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome measure was prevalence of recurrent goiter within the contralateral thyroid lobe', 'timeFrame': 'at 3, 6, 9, 12, 24, 36, 48 and 60 months postoperatively'}], 'secondaryOutcomes': [{'measure': 'Secondary outcome was the rate of the reoperation for the recurrent goiter', 'timeFrame': 'at 3, 6, 9, 12, 24, 36, 48 and 60 months postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Thyroid lobectomy,', 'prophylactic levothyroxine treatment,', 'recurrent nodular goiter,', 'iodine deficiency,', 'long-term follow-up,', 'completion thyroidectomy'], 'conditions': ['Recurrent Goiter']}, 'referencesModule': {'references': [{'pmid': '18475048', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15657583', 'type': 'BACKGROUND', 'citation': 'Bellantone 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.'}, {'pmid': '8256213', 'type': 'BACKGROUND', 'citation': 'Miccoli 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.'}, {'pmid': '8187295', 'type': 'BACKGROUND', 'citation': 'Bistrup 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.'}, {'pmid': '12354133', 'type': 'BACKGROUND', 'citation': 'Carella 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.'}, {'pmid': '39547954', 'type': 'DERIVED', 'citation': 'Barczynski 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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nIt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral multinodular goiter with normal appearing on ultrasound of the neck contralateral thyroid lobe, in a patient in euthyroid state\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT00941551', 'briefTitle': 'Thyroid Lobectomy With or Without Levothyroxine Treatment Postoperatively', 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'officialTitle': 'Five-year Follow up of a Randomized Clinical Trial of Unilateral Thyroid Lobectomy With or Without Levothyroxine Treatment Postoperatively', 'orgStudyIdInfo': {'id': 'BBN/501/ZKL/69/L'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'receiving levothyroxine postoperatively', 'interventionNames': ['Drug: levothyroxine']}, {'label': 'Group B', 'description': 'not-receiving levothyroxine postoperatively', 'interventionNames': ['Drug: no levothyroxine']}], 'interventions': [{'name': 'levothyroxine', 'type': 'DRUG', 'otherNames': ['LT4(+)'], 'description': 'levothyroxine 75-125 ug/day', 'armGroupLabels': ['Group A']}, {'name': 'no levothyroxine', 'type': 'DRUG', 'otherNames': ['LT4(-)'], 'description': 'observation only without prophylactic levothyroxine', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31-202', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'overallOfficials': [{'name': 'Marcin Barczynski, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jagiellonian University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jagiellonian University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Piotr Laider / Head of the Biomedical Research Committee of the Jagiellonian University', 'oldOrganization': 'Jagiellonian University medical College'}}}}