Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT00946894
Status:
COMPLETED
Last Update Posted:
2009-07-27
First Post:
2009-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006042', 'term': 'Goiter'}, {'id': 'D006044', 'term': 'Goiter, Nodular'}, {'id': 'D014826', 'term': 'Vocal Cord Paralysis'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D020421', 'term': 'Vagus Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-24', 'studyFirstSubmitDate': '2009-07-23', 'studyFirstSubmitQcDate': '2009-07-24', 'lastUpdatePostDateStruct': {'date': '2009-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome measure was prevalence of recurrent goiter and need for redo surgery.', 'timeFrame': 'at 12, 24, 36, 48 and 60 months after surgery'}], 'secondaryOutcomes': [{'measure': 'Secondary outcome measure was postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury).', 'timeFrame': 'at 3, 6, 9, 12, 24, 36, 48 and 60 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Total thyroidectomy', 'Subtotal thyroidectomy', 'Dunhill operation', 'Recurrent nodular goiter', 'Completion thyroidectomy', 'Recurrent laryngeal nerve palsy', 'Hypoparathyroidism following thyroidectomy', 'Recurrent goiter'], 'conditions': ['Goiter']}, 'referencesModule': {'references': [{'pmid': '17308855', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10326531', 'type': 'BACKGROUND', 'citation': 'Wheeler 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.'}, {'pmid': '15863948', 'type': 'BACKGROUND', 'citation': 'Ozbas 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.'}, {'pmid': '18305998', 'type': 'BACKGROUND', 'citation': 'Moalem 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.'}, {'pmid': '18958517', 'type': 'BACKGROUND', 'citation': 'Tezelman 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.'}, {'pmid': '18449595', 'type': 'BACKGROUND', 'citation': 'Agarwal 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.'}, {'pmid': '18311576', 'type': 'BACKGROUND', 'citation': 'Phitayakorn 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.'}, {'pmid': '19177420', 'type': 'BACKGROUND', 'citation': 'Barczynski 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.'}, {'pmid': '28942461', 'type': 'DERIVED', 'citation': 'Barczynski 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.'}, {'pmid': '20174803', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criterion\n\n* a bilateral non-toxic multinodular goiter with normal appearing on ultrasound of the neck posterior aspects of both thyroid lobes.\n\nExclusion Criteria:\n\n* multinodular goiter involving posterior aspect/s of thyroid lobe/s,\n* suspicion of thyroid cancer,\n* previous thyroid surgery,\n* thyroiditis,\n* subclinical or clinically overt hypothyroidism or hyperthyroidism,\n* pregnancy or lactation,\n* age \\< 18 years or \\> 65 years,\n* ASA 4 grade (American Society of Anesthesiology),\n* inability to comply with the follow-up protocol.'}, 'identificationModule': {'nctId': 'NCT00946894', 'briefTitle': 'Outcomes of Different Thyroid Resections for Multinodular Non-toxic Goiter', 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'officialTitle': 'Five-year Follow up of a Randomized Clinical Trial of Total Thyroidectomy Versus Dunhill Operation Versus Bilateral Subtotal Thyroidectomy for Multinodular Non-toxic Goiter.', 'orgStudyIdInfo': {'id': 'BBN/501/ZKL/68/L'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Total thyroidectomy', 'description': 'Patients who underwent total thyroidectomy', 'interventionNames': ['Procedure: Total thyroidectomy']}, {'type': 'EXPERIMENTAL', 'label': 'Dunhill operation', 'description': 'Patients who underwent unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy', 'interventionNames': ['Procedure: Dunhill operation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bilateral subtotal thyroidectomy', 'description': 'Patients who underwent bilateral subtotal thyroidectomy', 'interventionNames': ['Procedure: Bilateral subtotal thyroidectomy']}], 'interventions': [{'name': 'Total thyroidectomy', 'type': 'PROCEDURE', 'otherNames': ['TT'], 'description': 'Total thyroidectomy', 'armGroupLabels': ['Total thyroidectomy']}, {'name': 'Dunhill operation', 'type': 'PROCEDURE', 'otherNames': ['DO'], 'description': 'Unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy', 'armGroupLabels': ['Dunhill operation']}, {'name': 'Bilateral subtotal thyroidectomy', 'type': 'PROCEDURE', 'otherNames': ['BST'], 'description': 'Bilateral subtotal thyroidectomy', 'armGroupLabels': ['Bilateral subtotal thyroidectomy']}]}, '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'}}}}