Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-27 @ 4:51 PM
Study NCT ID:
NCT05474261
Status:
COMPLETED
Last Update Posted:
2022-07-29
First Post:
2022-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Valsalva Maneuver in Thyroidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014636', 'term': 'Valsalva Maneuver'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-15', 'size': 424686, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-07-19T17:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2022-07-19', 'studyFirstSubmitQcDate': '2022-07-22', 'lastUpdatePostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volume of cervical drainage after total thyroidectomy', 'timeFrame': '24 hours', 'description': 'Bleeding after thyroidectomy is evaluated based on the total volume of cervical drainage output (ml)'}, {'measure': 'Number of reinterventions', 'timeFrame': '24 hours', 'description': 'Reoperations to resolve post thyroidectomy bleeding, which can cause airway compression and choking signs and symptoms.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['The Role of Valsalva Manoeuvre, in Thyroidectomy to Reduce Postoperative Bleeding']}, 'descriptionModule': {'briefSummary': 'Bleeding after total thyroidectomy remains a rare event that affects early postoperative morbidity, occurring in 0.3% up to 4.2% of cases. Intraoperative bleeding is an unpleasant complication, and it is often easily manageable though postoperative bleeding may represent a life-threatening condition for the patient.\n\nBetween January 2019 to February 2022 , 250 consecutive patients were listed for thyroidectomy. The Investigators selected 178 patients and divided them in two groups based on the execution of the Valsalva Manoeuvre.\n\nThe purpose of the investigator is to clarify whether the routine intraoperative execution of a Valsalva manoeuvre (VM) may affect the detection of bleeding that would otherwise remain occult and therefore may manifest in the postoperative period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients underwent total thyroidectomy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* thyroid diseases\n\nExclusion Criteria:\n\n* lymph node dissection\n* minimally invasive approaches\n* high anesthesiological risk'}, 'identificationModule': {'nctId': 'NCT05474261', 'briefTitle': 'Valsalva Maneuver in Thyroidectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Foggia'}, 'officialTitle': 'Clinical Usefulness of the Valsalva Maneuver to Improve Hemostasis During Thyroidectomy', 'orgStudyIdInfo': {'id': 'UFoggia2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GROUP A-NO Valsalva maneuver'}, {'label': 'GROUP B- Valsalva maneuver', 'interventionNames': ['Procedure: Valsalva maneuver']}], 'interventions': [{'name': 'Valsalva maneuver', 'type': 'PROCEDURE', 'description': 'Valsalva maneuver: increase intrabdominal pressure', 'armGroupLabels': ['GROUP B- Valsalva maneuver']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71122', 'city': 'Foggia', 'country': 'Italy', 'facility': 'Policlinico Di Foggia', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Foggia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mario Pacilli', 'investigatorAffiliation': 'University of Foggia'}}}}