Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-20 @ 4:32 PM
Study NCT ID:
NCT02683551
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2015-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of QoL for Sutureless Thyroidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 193}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-07', 'studyFirstSubmitDate': '2015-10-24', 'studyFirstSubmitQcDate': '2016-02-11', 'lastUpdatePostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall alterations in quality of life according to Thy-PRO-39 questionnaire', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Alterations in social life according to Thy-PRO-39 questionnaire', 'timeFrame': '4 weeks'}, {'measure': 'Alterations in daily life according to Thy-PRO-39 questionnaire', 'timeFrame': '4 weeks'}, {'measure': 'Alterations in Tiredness according to Thy-PRO-39 questionnaire', 'timeFrame': '4 weeks'}, {'measure': 'Alterations in cognitive complaints according to Thy-PRO-39 questionnaire', 'timeFrame': '4 weeks'}, {'measure': 'Alterations in anxiety according to Thy-PRO-39 questionnaire', 'timeFrame': '4 weeks'}, {'measure': 'Alterations in depressivity according to Thy-PRO-39 questionnaire', 'timeFrame': '4 weeks'}, {'measure': 'Alterations in emotional susceptibility according to Thy-PRO-39 questionnaire', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Thyroidectomy', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '26214034', 'type': 'BACKGROUND', 'citation': 'Watt T, Bjorner JB, Groenvold M, Cramon P, Winther KH, Hegedus L, Bonnema SJ, Rasmussen AK, Ware JE Jr, Feldt-Rasmussen U. Development of a Short Version of the Thyroid-Related Patient-Reported Outcome ThyPRO. Thyroid. 2015 Oct;25(10):1069-79. doi: 10.1089/thy.2015.0209. Epub 2015 Aug 26.'}], 'seeAlsoLinks': [{'url': 'http://www.drenes.com/', 'label': 'Data collection and information release system'}]}, 'descriptionModule': {'briefSummary': 'Patients underwent thyroidectomy filled an computer or paper based QoL questionnaire before and after operation.', 'detailedDescription': 'Patients who have consent to undergo to total thyroidectomy with sutureless technique (regardless of attending to study or not) for benign thyroid diseases in the institution are asked to participate to this study. Patients are informed that participating to this study will not alter their treatment method. Patients were operated either with Ligasure SmallJaw or Harmonic Focus according to result of label picked from bag. Same surgical team performed all operations and they did not know if the patient was participated in study or not.\n\nPatients willing to participate in this study are being questioned for their quality of life (QoL) with a patient-reported outcome (PRO) questionnaire before surgery and 4 weeks after surgery. For assessment of quality of life Thy-PRO-39 questionnaire is being used. Responses of patients to QoL questionnaire is being recorded to a secure online database. After data completion answers of patients will be exported as anonymous to principal investigator for analysis. Effect of two energy based devices (EBD) on QOL will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who has planned to undergo to sutureless thyroidectomy for benign conditions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sutureless thyroidectomy for benign conditions\n\nExclusion Criteria:\n\n* Known neck malignity,\n* History of neck operation\n* Ligation use during surgery\n* Refusal of patient\n* Non-capable patient\n* Non-euthyroid patient\n* Pregnancy\n* Having rheumatic diseases\n* Having connective tissue diseases'}, 'identificationModule': {'nctId': 'NCT02683551', 'briefTitle': 'Comparison of QoL for Sutureless Thyroidectomy', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Comparison of Effects of Energy Based Devices on Quality of Life After Sutureless Thyroidectomy?', 'orgStudyIdInfo': {'id': 'IUCTF-EndSx-2015-01'}, 'secondaryIdInfos': [{'id': '83045809/604.01/02', 'type': 'OTHER', 'domain': 'Ethical Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ligasure', 'description': 'Patients underwent to Sutureless Thyroidectomy with Ligasure SmallJaw', 'interventionNames': ['Procedure: Sutureless Thyroidectomy']}, {'label': 'Harmonic', 'description': 'Patients underwent to Sutureless Thyroidectomy with Harmonic FOCUS', 'interventionNames': ['Procedure: Sutureless Thyroidectomy']}], 'interventions': [{'name': 'Sutureless Thyroidectomy', 'type': 'PROCEDURE', 'description': 'Thyroidectomy performed with energy based devices and no use of ligation. Used device is not altered for this study. Non of the personnel in the operating room including surgical team knows if the patient was enrolled or not in this study.', 'armGroupLabels': ['Harmonic', 'Ligasure']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ates OZYEGIN, Prof, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University, Cerrahpasa Medical Faculty'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Akif Enes ARIKAN', 'investigatorAffiliation': 'Istanbul University'}}}}