Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2026-02-22 @ 4:10 AM
Study NCT ID:
NCT02486393
Status:
COMPLETED
Last Update Posted:
2015-07-01
First Post:
2015-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complications in Parotid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005158', 'term': 'Facial Paralysis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-28', 'studyFirstSubmitDate': '2015-06-25', 'studyFirstSubmitQcDate': '2015-06-28', 'lastUpdatePostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'facial palsy', 'timeFrame': 'post op 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Facial Palsy']}, 'descriptionModule': {'briefSummary': 'The investigators conducted a prospective study of 132 patients undergoing benign parotid surgery at our department. Their primary objective was to analyze the incidence of and contributing factors associated with temporary and permanent postoperative facial palsy with strictly standardized methods in facial nerve function evaluation. Also other complications occurring within 12 months of operation were recorded.', 'detailedDescription': 'Patients who underwent parotid surgery at the Department of Otorhinolaryngology - Head and Neck Surgery, Helsinki University Hospital, Helsinki, Finland, between September 2011 and November 2012 were prospectively enrolled. Exclusion criteria were age under 18, suspicion of malignancy or facial schwannoma, a tumor extending into the parapharyngeal space, and previous parotid surgery exposing facial nerve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent parotid surgery at the Department of Otorhinolaryngology - Head and Neck Surgery, Helsinki University Hospital, Helsinki, Finland, between September 2011 and November 2012 were prospectively enrolled', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* parotid gland tumour surgery\n\nExclusion Criteria:\n\n* age under 18\n* suspicion of malignancy or facial schwannoma\n* a tumor extending into the parapharyngeal space\n* previous parotid surgery exposing facial nerve'}, 'identificationModule': {'nctId': 'NCT02486393', 'briefTitle': 'Complications in Parotid Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Complications in Parotid Surgery - a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'JR/Helsinki/ORL/'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'type of surgery', 'description': 'patients undergoing parotid surgery', 'interventionNames': ['Procedure: Parotid surgery']}], 'interventions': [{'name': 'Parotid surgery', 'type': 'PROCEDURE', 'description': 'Surgery of the parotid gland tumours', 'armGroupLabels': ['type of surgery']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Leif Bäck', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}