Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 9:31 AM
Study NCT ID:
NCT01907256
Status:
COMPLETED
Last Update Posted:
2014-01-20
First Post:
2013-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing the Aesthetic Results of Two Common Incisions in External Rhinoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-17', 'studyFirstSubmitDate': '2013-07-11', 'studyFirstSubmitQcDate': '2013-07-18', 'lastUpdatePostDateStruct': {'date': '2014-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hollunder cosmetic score', 'timeFrame': 'one week after surgery,', 'description': 'The patients will come for office visit and their columella scars will evaluate according to above mentioned scale in one week after surgery, one month after surgery , one year after surgery'}, {'measure': 'Hollunder cosmetic score', 'timeFrame': 'one month after surgery', 'description': 'The patients will come for office visit and their columella scars will evaluate according to above mentioned scale in one week after surgery, one month after surgery , one year after surgery'}, {'measure': 'Hollunder cosmetic score', 'timeFrame': 'one year after surgery', 'description': 'The patients will come for office visit and their columella scars will evaluate according to above mentioned scale in one week after surgery, one month after surgery , one year after surgery'}], 'secondaryOutcomes': [{'measure': 'Visual analogue score', 'timeFrame': 'one week after surgery,', 'description': 'The patients will come for office visit and their columella scars will evaluate according to above mentioned scale inone week after surgery, one month after surgery , one year after surgery'}, {'measure': 'Visual analogue score', 'timeFrame': 'one month after surgery', 'description': 'The patients will come for office visit and their columella scars will evaluate according to above mentioned scale inone week after surgery, one month after surgery , one year after surgery'}, {'measure': 'Visual analogue score', 'timeFrame': 'one year after surgery', 'description': 'The patients will come for office visit and their columella scars will evaluate according to above mentioned scale inone week after surgery, one month after surgery , one year after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cosmetic Outcome']}, 'descriptionModule': {'briefSummary': 'There was not any randomize trial to show what is the best type of incision in open rhinoplasty. So, we use both self-rating by patients ,independent physician observers Visual Analogue Scale (VAS) and also a validated scar analysis to compare inverted V and stair step incisions.', 'detailedDescription': 'Approaches to rhinoplasty can be separated into two broad categories: external and endonasal, which each of them their own proponent. However, the external approach provide better exposure, critics against this technique is often due to cosmetic deformity regarding the incision. Hence, over the recent years surgeons have modified the trans-columellar incision into two big categories: gull wing and stair steps. While each of them has its own proponents, there is no randomized trial, comparing their cosmetic results.\n\nThere was not any randomize trial to show what is the best type of incision in open rhinoplasty. So, we use both self-rating by patients ,independent physician observers Visual Analogue Scale (VAS) and also a validated scar analysis to compare inverted V and stair step incisions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who candidate for open rhinoplasty\n\nExclusion Criteria:\n\n* Revision cases\n* History of scar\n* Systemic diseases'}, 'identificationModule': {'nctId': 'NCT01907256', 'briefTitle': 'Comparing the Aesthetic Results of Two Common Incisions in External Rhinoplasty', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'Comparing the Aesthetic Results of Two Common Incisions in External Rhinoplasty A Randomized Trial', 'orgStudyIdInfo': {'id': '92-01-48-20912'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A', 'description': 'stair step incisions', 'interventionNames': ['Procedure: stair step incisions']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'inverted V incision', 'interventionNames': ['Procedure: inverted V incision']}], 'interventions': [{'name': 'inverted V incision', 'type': 'PROCEDURE', 'description': 'It is a type of incision', 'armGroupLabels': ['Group B']}, {'name': 'stair step incisions', 'type': 'PROCEDURE', 'description': 'It is a type of incision', 'armGroupLabels': ['group A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Tehran University of Medical Sciences', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Babak Saaedi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tehran University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Babak Saedi', 'investigatorAffiliation': 'Tehran University of Medical Sciences'}}}}