Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT03100357
Status:
UNKNOWN
Last Update Posted:
2017-04-04
First Post:
2017-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Esophageal Motility and Swallowing Symptoms After Thyroid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}], 'ancestors': [{'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013965', 'term': 'Thyroidectomy'}], 'ancestors': [{'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-28', 'studyFirstSubmitDate': '2017-03-14', 'studyFirstSubmitQcDate': '2017-03-28', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motility disturbances', 'timeFrame': 'Before and six months following thyroidectomy', 'description': 'Change in number of failed swallowings from baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Motility Disorders']}, 'referencesModule': {'references': [{'pmid': '29043407', 'type': 'DERIVED', 'citation': 'Sorensen JR, Markoew S, Dossing H, Hegedus L, Bonnema SJ, Godballe C. Changes in Swallowing Symptoms and Esophageal Motility After Thyroid Surgery: A Prospective Cohort Study. World J Surg. 2018 Apr;42(4):998-1004. doi: 10.1007/s00268-017-4247-5.'}]}, 'descriptionModule': {'briefSummary': 'The pronounced effect of goiter on the esophagus needs further exploration, as the mechanisms by which goiter leads to swallowing difficulties are unknown. By investigating esophageal motility using high resolution esophageal manometry before and after thyroidectomy we seek to examine the impact of the goiter mass on the esophagus and swallowing with six months follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with benign nodular goiter', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with symptomatic benign nodular goiter referred for thyroidectomy\n\nExclusion Criteria:\n\n* Previous surgery to the neck;\n* Suspicion of thyroid cancer\n* Age below 20 years or above 80 years\n* Neuromuscular disease.'}, 'identificationModule': {'nctId': 'NCT03100357', 'briefTitle': 'Changes in Esophageal Motility and Swallowing Symptoms After Thyroid Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Changes in Esophageal Motility and Swallowing Symptoms After Thyroid Surgery - a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'SOLOIST4'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Thyroidectomy', 'type': 'OTHER', 'description': 'Thyroid surgery for benign nodular goiter'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD fellow', 'investigatorFullName': 'Jesper Roed Sorensen', 'investigatorAffiliation': 'University of Southern Denmark'}}}}