Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-05 @ 6:03 PM
Study NCT ID:
NCT01945502
Status:
UNKNOWN
Last Update Posted:
2013-09-18
First Post:
2013-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nasopharyngeal Packing and Rhinologic Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'lastUpdateSubmitDate': '2013-09-16', 'studyFirstSubmitDate': '2013-09-16', 'studyFirstSubmitQcDate': '2013-09-16', 'lastUpdatePostDateStruct': {'date': '2013-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative nausea vomiting', 'timeFrame': '3 months'}, {'measure': 'sore throat', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Nasal Surgery', 'Tampons', 'PONV']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of three different pharyngeal packing during routine rhinologic surgery in the prevention of postoperative nausea and vomiting, and to evaluate the influence of pharyngeal packing on postoperative throat pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (18-60 years) scheduled for routine nasal and/or paranasal sinus surgeries in Ankara Univerity Faculty of Medicine, ETN operating rooms were recruited into this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-60 years old adult patient\n* nasal and/or paranasal sinus surgeries\n* general anesthesia\n\nExclusion Criteria:\n\n* patients submitted to another intervention at the same time (adenoidectomy, tonsillectomy)\n* patients with a serious systemic disease (acquired immunodeficiency syndrome,leukemia, lymphoma, or other neoplasias under chemotherapy treatment)\n* patients presenting contraindications for using nonsteroid anti-inflammatory drugs'}, 'identificationModule': {'nctId': 'NCT01945502', 'briefTitle': 'Nasopharyngeal Packing and Rhinologic Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'The Effectiveness of Three Different Nasopharyngeal Packing on the Prevention of Postoperative Nausea- Vomiting and Postoperative Throat Pain in Rhinologic Surgery.', 'orgStudyIdInfo': {'id': '11-434-13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'nasal packing with dry packs'}, {'label': 'nasal packing with wet packs'}, {'label': 'nasal packing with Benzidamin-Clorhexsidin damped packs'}, {'label': 'no nasal packing'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Basak Ceyda MECO, MD, DESA', 'role': 'CONTACT', 'email': 'basakceyda@hotmail.com', 'phone': '0090 532 4179911'}], 'facility': 'Ankara University Faculty of Medicine ENT operating rooms', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Basak Ceyda MECO', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, DESA', 'investigatorFullName': 'Basak Ceyda MECO', 'investigatorAffiliation': 'Ankara University'}}}}