Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-02 @ 2:17 PM
Study NCT ID:
NCT04998968
Status:
UNKNOWN
Last Update Posted:
2021-08-25
First Post:
2021-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2021-08-09', 'studyFirstSubmitQcDate': '2021-08-09', 'lastUpdatePostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life using SF-36 short form', 'timeFrame': '2021', 'description': 'The SF-36 yields eight scale scores and two summary scores, the physical component summary (PCS) and mental component summary (MCS). Scoring PCS and MCS involves three steps: 1) standardization of the scales (z-scores) 2) aggregation of score scales and 3) transformation of summary scores (t-scores). For each domain (PCS and MCS) the mean score is 50 with a standard deviation of 10. Higher scores indicates better quality of life (score range 0-100)'}]}, 'conditionsModule': {'conditions': ['Permanent Hypoparathyroidism']}, 'descriptionModule': {'briefSummary': 'Quality of life study. The study with include all patients operated with total thyroidectomy between 2005-2015 in Uppsala-Örebro healthcare region, Sweden. The study population has been identified in a previous study and includes close to 1700 patients, of which about 200 developed permanent hypoparathyroidism after surgery.\n\nQuality of Life will be assessed using SF-36 Health Surgery and the outcome for patients with and without permanent hypoparathyroidism will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients are identified through the national quality registry for endocrine surgery, SQRTPA and the Swedish National Patient Register', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Total thyroidectomy between 2005-2015 in Uppsala-Orebro healthcare region.\n\nExclusion Criteria:\n\n* Malignancy\n* Sternotomy\n* Previous thyroid surgery\n* Previous or concurrent parathyroidectomy'}, 'identificationModule': {'nctId': 'NCT04998968', 'briefTitle': 'Quality in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Quality of Life in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy in a Swedish Population Based Cohort', 'orgStudyIdInfo': {'id': '2021-01997'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with permanent hypoparathyroidism after total thyroidectomy', 'description': 'Patients with permanent hypoparathyroidism after total thyroidectomy for benign thyroid disease. These patients should be operated between 2005-2015 in Uppsala-Örebro healthcare region. Permanent hypoparathyroidism is defined as treatment with Calcium and/or vitamin D more than 12 months after surgery.'}, {'label': 'Patients without permanent hypoparathyroidism after total thyroidectomy', 'description': 'Patients without permanent hypoparathyroidism after total thyroidectomy for benign thyroid disease. These patients should be operated between 2005-2015 in Uppsala-Örebro healthcare region.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Olov Norlén, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}