Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-25 @ 8:52 PM
Study NCT ID:
NCT04871256
Status:
COMPLETED
Last Update Posted:
2021-05-04
First Post:
2021-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Septorhinoplasty on Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D015508', 'term': 'Nasal Obstruction'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000402', 'term': 'Airway Obstruction'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-06-30', 'size': 314675, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2021-04-28T02:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A prospective study with 1 months period follow up. Patients with septal deviation and allergic rhinitis diagnosis will be included. Obstruction airflow will be evaluated before and after surgery with rhinomanometry (RNM). Life quality will be assessed with VAS and ESPRINTquestionnaires.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-28', 'studyFirstSubmitDate': '2021-01-14', 'studyFirstSubmitQcDate': '2021-04-28', 'lastUpdatePostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline of Airflow rate', 'timeFrame': 'Change from baseline airflow rate (Before treatment) at 1 month after surgery', 'description': 'Rhinomanometre will be used to determine airflow rate changes before surgery (septoplasty) and after it. Rhinomanometre will determine airflow rate in cm3/s and also use a quality scale as normal, mild, severe and very severe'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline of symptoms', 'timeFrame': 'Changes from baseline (Before treatment) at 1 month after surgery', 'description': 'VAS score. VAS: visual analogue scale. Patients determine their symptoms with a visual scale that range from 0-10.'}, {'measure': 'Changes from baseline in quality of life', 'timeFrame': 'Changes from baseline (Before treatment) at 1 month after surgery', 'description': 'ESPRINT questionnaire. This is a validated spanish questionnaire about daily life impairments with 28 items.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Septoplasty', 'VAS', 'quality of life', 'allergic rhinitis', 'nasal obstruction'], 'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'Allergic rhinitis (AR) is a chronic inflammatory disease that affects almost 30% of adult population. Some patients associate septal deviation, main cause of chronic nasal obstruction, and AR. Current literature about AR treatment with septoplasty (STP) is still contradictory, because is thought that patients with AR are not able to appreciate improvement after surgery.\n\nPatients diagnosed with allergic rinitis and septal deviation were evaluated to determined life quality and airflow obstruction evolution after STP.', 'detailedDescription': 'This is a prospective quasi experimental study. After being informed about the study, patients that signed written informed consent were included in the study. In week 0 before surgery, all measurements and questionnaires were performed. 1 month after surgery, measurements were repeated.\n\nAfter screening, patient´s obstruction was evaluated by anterior rhinomanometry (RNMa), and quality of life scored through ESPRINT scale. ESPRINT is a validated Spanish questionnaire about daily life activity, sleep, psycology and perception of affection by allergic rhinitis. Symtoms were evaluated with visual analogue scale (VAS) and clinical history. Symptoms like sneezing, itchy nose, ocular symptoms and/or nasal obstruction. Also medication (intranasal corticosteroid, antileucotrienos, antihistamines eye drops , antishistamines) frequency use was registered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Allergic Rhinitis\n* Diagnosis of nasal obstruction with septal deviation\n\nExclusion Criteria:\n\n* Previous nasal surgery\n* Smokers\n* Chronic obstructive pulmonary disease\n* Psychiatric disorders\n* Malignant tumors\n* Severe hepatopathy\n* Obstructive sleep apnea'}, 'identificationModule': {'nctId': 'NCT04871256', 'briefTitle': 'Effects of Septorhinoplasty on Allergic Rhinitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Santiago de Compostela'}, 'officialTitle': 'Effects of Septorhinoplasty on Allergic Rhinitis Evolution', 'orgStudyIdInfo': {'id': 'AR/STP-UDC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inver', 'description': 'Intervention: after screening, patient´s obstruction will be evaluated by anterior rhinomanometry (RNMa), and quality of life wil be scored through ESPRINT scale. ESPRINT is a validated Spanish questionnaire about daily life activity, sleep, psychology and perception of affection by allergic rhinitis.\n\nSymptoms will be evaluated with visual analogue scale (VAS) and clinical history. Symptoms like sneezing, itchy nose, ocular symptoms and/or nasal obstruction. Also medication (intranasal corticosteroid, antileukotrienes, antihistamine eye drops, antihistamine) frequency use will be registered', 'interventionNames': ['Procedure: Septorhinoplasty']}], 'interventions': [{'name': 'Septorhinoplasty', 'type': 'PROCEDURE', 'description': 'This intervention will be performed by the same surgeon, after signing of patient inform consent.', 'armGroupLabels': ['Inver']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15785', 'city': 'Santiago de Compostela', 'state': 'A Coruña', 'country': 'Spain', 'facility': 'Mario Pérez Sayáns', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Results will be shared by articles publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mario Pérez Sayáns', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidade da Coruña', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Proffessor', 'investigatorFullName': 'Mario Pérez Sayáns', 'investigatorAffiliation': 'University of Santiago de Compostela'}}}}