Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-02-20 @ 8:08 PM
Study NCT ID:
NCT02855866
Status:
COMPLETED
Last Update Posted:
2018-12-21
First Post:
2016-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013965', 'term': 'Thyroidectomy'}, {'id': 'D017679', 'term': 'Cryotherapy'}, {'id': 'C018038', 'term': 'dexamethasone acetate'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2015-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2016-07-28', 'studyFirstSubmitQcDate': '2016-08-03', 'lastUpdatePostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Swallowing Impairment Score (SIS).', 'timeFrame': 'Evolution of the SIS from baseline (inclusion), to the end of the surgery and every day thereafter until discharge of the patient(up to 3 months)'}]}, 'conditionsModule': {'conditions': ['Thyroidectomy', 'Post-operative Swallowing Disorders']}, 'descriptionModule': {'briefSummary': 'The scientific interest of this study is to improve post-operative comfort in patients after thyroid surgery using simple, inexpensive techniques. The investigator expects that local applications of ice or cortisone aerosols will reduce swallowing discomfort and control post-operative pain (POP). The investigator hopes that local cryotherapy will decrease post-operative oedema (vasoconstriction) and the volume of liquid drained (action on the serous fluid at the site of the thyroidectomy).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients about to undergo total thyroidectomy by cervicotomy\n* Single surgeon: Dr Osmak-Tizon Liliana\n* Patients who have provided written consent to take part in the research\n* Hospitalized in the endocrine surgery unit\n* Whose mental and physical state allows them to participate in the quantification of a symptom using a Visual Analogue Scale(VAS)\n\nExclusion Criteria:\n\n* Patients under 18 or adults under guardianship\n* Patients about to undergo unilateral thyroid surgery (thyroid lobectomy)\n* Patient who have had parathyroid surgery\n* History of cervicotomy\n* Intolerance to, contra-indication for or allergy to any of the treatments tested.\n* Pregnant or breast-feeding women\n* Patients without national health insurance cover'}, 'identificationModule': {'nctId': 'NCT02855866', 'acronym': 'DEGLUTHYR', 'briefTitle': 'Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroidectomy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroidectomy', 'orgStudyIdInfo': {'id': 'OSMAK POUSSIER 2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cryotherapy', 'interventionNames': ['Procedure: thyroidectomy', 'Other: cryotherapy', 'Drug: Dexamethasone acetate', 'Drug: paracetamol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cortisone aerosol', 'interventionNames': ['Procedure: thyroidectomy', 'Drug: cortisone aerosol', 'Drug: Dexamethasone acetate', 'Drug: paracetamol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Management', 'interventionNames': ['Procedure: thyroidectomy', 'Drug: Dexamethasone acetate', 'Drug: paracetamol']}], 'interventions': [{'name': 'thyroidectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Cortisone aerosol', 'Management', 'cryotherapy']}, {'name': 'cryotherapy', 'type': 'OTHER', 'armGroupLabels': ['cryotherapy']}, {'name': 'cortisone aerosol', 'type': 'DRUG', 'armGroupLabels': ['Cortisone aerosol']}, {'name': 'Dexamethasone acetate', 'type': 'DRUG', 'armGroupLabels': ['Cortisone aerosol', 'Management', 'cryotherapy']}, {'name': 'paracetamol', 'type': 'DRUG', 'armGroupLabels': ['Cortisone aerosol', 'Management', 'cryotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}