Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-02 @ 9:40 PM
Study NCT ID:
NCT02818634
Status:
UNKNOWN
Last Update Posted:
2016-06-30
First Post:
2016-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Costal Harvesting Technique on Postoperative Donor-site Morbidity: Does Muscle Sparing Technique Cause Less Postoperative Pain ? A Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-27', 'studyFirstSubmitDate': '2016-06-17', 'studyFirstSubmitQcDate': '2016-06-27', 'lastUpdatePostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Postoperative Pain', 'timeFrame': 'Postoperative first 45 days', 'description': 'Postoperative pain and its change from baseline to 45th postoperative day will be evaluated with Visual Analogue Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Nasal Deformity', 'Revision Rhinoplasty', 'Autogenous Rib Graft', 'Costal Cartilage', 'Harvesting']}, 'referencesModule': {'references': [{'pmid': '26616708', 'type': 'BACKGROUND', 'citation': 'Fedok FG. Costal Cartilage Grafts in Rhinoplasty. Clin Plast Surg. 2016 Jan;43(1):201-12. doi: 10.1016/j.cps.2015.08.002. Epub 2015 Oct 24.'}, {'pmid': '26616707', 'type': 'BACKGROUND', 'citation': 'Cochran CS. Harvesting Rib Cartilage in Primary and Secondary Rhinoplasty. Clin Plast Surg. 2016 Jan;43(1):195-200. doi: 10.1016/j.cps.2015.09.018. Epub 2015 Oct 23.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study was to investigate the effect of 'muscle sparing technique' while harvesting costal/rib cartilage on postoperative donor-site morbidity -namely postoperative pain. Although authors report 'muscle sparing technique' cause less pain its not investigated in an evidence-based-medicine perspective. Therefore the investigators are planning a controlled, prospective clinical trial to compare the conventional method and 'muscle sparing technique'.\n\nEffect of Costal Harvesting Technique on Postoperative Donor-site Morbidity: Does Muscle Sparing Technique Cause Less Postoperative Pain ? A Clinical Trial", 'detailedDescription': "Revision rhinoplasty patients requiring costal cartilage were enrolled in the study. All costal cartilage harvestings were full-thickness and they were carried out by a single-surgeon (Berke Ozucer). Patients were randomly assigned either to 'Conservative Muscle-cuttingHarvesting Technique' or 'Muscle-sparing Harvesting Technique'.\n\nSurgical technique costal cartilage harvesting in both groups were identical expect this:\n\nM-Cutting group : Following skin incision with No.15 blade; all layers including the subcutaneous fat, muscle fascia and muscles covering the cartilage were cut with Monopolar electrocautery at (25 watts).\n\nM-Sparing group: : Following skin incision with No.15 blade; all layers including the subcutaneous fat, muscle fascia and muscles covering the cartilage were passed with blunt dissection. Muscle fibers were dissected parallel to their positioning.\n\nPostoperative pain was evaluated with a Visual Analogue Scale. Participants were questioned regarding their donor-site pain and asked to score their pain 0 (minimum and 10 (maximum). Passive state and pain while active was evaluated separately. This evaluation was carried out at 6th postoperative hour, first, second, third postoperative-days, first postoperative week, on 15th ,30th and 45th day postoperatively. Also postoperative need for analgesics were also noted for the first three days.\n\nMuscle-cutting and muscle-sparing groups were analysed for mean ± Standard deviation values. These values were compared statistically to assess whether muscle-sparing technique has a significant effect on reduced postoperative pain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Revision rhinoplasty\n* when costal cartilage is harvested full-thickness\n\nExclusion Criteria:\n\n* Fibromyalgia\n* No consent\n* When patient does not comply with follow-up'}, 'identificationModule': {'nctId': 'NCT02818634', 'acronym': 'COSTA', 'briefTitle': 'Effect of Costal Harvesting Technique on Postoperative Donor-site Morbidity: Does Muscle Sparing Technique Cause Less Postoperative Pain ? A Clinical Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Gaziosmanpasa Research and Education Hospital'}, 'officialTitle': 'Effect of Costal Harvesting Technique on Postoperative Donor-site Morbidity: Does Muscle Sparing Technique Cause Less Postoperative Pain ? A Clinical Trial', 'orgStudyIdInfo': {'id': 'COSTA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Muscle-sparing', 'description': 'Following skin incision with No.15 blade; all layers including the subcutaneous fat, muscle fascia and muscles covering the cartilage were passed with blunt dissection. Muscle fibers were dissected parallel to their positioning.', 'interventionNames': ['Procedure: Harvesting rib cartilage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Muscle-cutting', 'description': 'Following skin incision with No.15 blade; all layers including the subcutaneous fat, muscle fascia and muscles covering the cartilage were cut with Monopolar electrocautery at (25 watts).', 'interventionNames': ['Procedure: Harvesting rib cartilage']}], 'interventions': [{'name': 'Harvesting rib cartilage', 'type': 'PROCEDURE', 'armGroupLabels': ['Muscle-cutting', 'Muscle-sparing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Istanbul', 'state': 'Gaziosmanpasa', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Berke Ozucer, MD', 'role': 'CONTACT', 'email': 'berkeozucer@gmail.com', 'phone': '90-530-963-5939'}, {'name': 'Emre M Dinc, MD', 'role': 'CONTACT', 'email': 'dremredinc@hotmail.com', 'phone': '905065426492'}], 'facility': 'Gaziosmanpasa Taksim Research and Education Hospital, Department of Otorhinolaryngology', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Berke Ozucer, MD', 'role': 'CONTACT', 'email': 'berkeozucer@gmail.com', 'phone': '905309635939'}, {'name': 'Mehmet E Dinc, MD', 'role': 'CONTACT', 'email': 'dremredinc@hotmail.com', 'phone': '905065426492'}], 'overallOfficials': [{'name': 'Berke Ozucer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gaziosmanpasa Taksim Research and Education Hospital, Otorhinolaryngology Deparment'}, {'name': 'Mehmet E Dinc, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gaziosmanpasa Taksim Research and Education Hospital, Otorhinolaryngology Deparment'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziosmanpasa Research and Education Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Otolaryngologist', 'investigatorFullName': 'Berke Ozucer', 'investigatorAffiliation': 'Gaziosmanpasa Research and Education Hospital'}}}}