Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-02-22 @ 11:25 PM
Study NCT ID:
NCT02672956
Status:
COMPLETED
Last Update Posted:
2022-03-29
First Post:
2016-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Different Umbilical Port Entry Techniques in Terms of Cosmetic Results
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013525', 'term': 'Surgical Instruments'}], 'ancestors': [{'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-13', 'studyFirstSubmitDate': '2016-01-21', 'studyFirstSubmitQcDate': '2016-01-29', 'lastUpdatePostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The results of vancouver scar scale', 'timeFrame': 'One month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cicatrix']}, 'referencesModule': {'references': [{'pmid': '18839082', 'type': 'BACKGROUND', 'citation': 'Kim E, Kim D, Lee S, Lee H. Minimal-scar laparoscopic adjustable gastric banding (LAGB). Obes Surg. 2009 Apr;19(4):500-3. doi: 10.1007/s11695-008-9713-6. Epub 2008 Oct 7.'}, {'pmid': '21856076', 'type': 'RESULT', 'citation': 'Park SK, Olweny EO, Best SL, Tracy CR, Mir SA, Cadeddu JA. Patient-reported body image and cosmesis outcomes following kidney surgery: comparison of laparoendoscopic single-site, laparoscopic, and open surgery. Eur Urol. 2011 Nov;60(5):1097-104. doi: 10.1016/j.eururo.2011.08.007. Epub 2011 Aug 12.'}, {'pmid': '21150398', 'type': 'RESULT', 'citation': 'Nozaki T, Ichimatsu K, Watanabe A, Komiya A, Fuse H. Longitudinal incision of the umbilicus for laparoendoscopic single site adrenalectomy: a particular intraumbilical technique. Surg Laparosc Endosc Percutan Tech. 2010 Dec;20(6):e185-8. doi: 10.1097/SLE.0b013e3181f70a2a.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/21856076', 'label': 'Related Info'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed/?term=Longitudinal+Incision+of+the+Umbilicus+for+Laparoendoscopic+Single+Site+Adrenalectomy%3A+A+Particular+Intraumbilical+Technique', 'label': 'Related Info'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed/?term=Minimal-Scar+Laparoscopic+Adjustable+Gastric+Banding+(LAGB)', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Investigators selected participants who operated by laparoscopic technique due to any gynecologic indication according to random number table. The ten mm trocar was inserted supraumbilical, infraumbilical and intraumbilical. The verres needle was not used in all of patients. One month after we evaluated umbilical scar by used vancouver scar scale and compared results of vancouver scar scale.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant with eligible for laparoscopic surgery\n\nExclusion Criteria:\n\n* Participant with umbilical scar due to previous surgery, burn eg.'}, 'identificationModule': {'nctId': 'NCT02672956', 'briefTitle': 'Comparison of Different Umbilical Port Entry Techniques in Terms of Cosmetic Results', 'organization': {'class': 'OTHER', 'fullName': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital'}, 'officialTitle': 'Comparison of Different Umbilical Port Entry Techniques in Terms of Cosmetic Results', 'orgStudyIdInfo': {'id': '129'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supraumbilical entry group', 'description': 'Umbilical port will be insert to supra umbilical area.', 'interventionNames': ['Procedure: Ten mm trocar']}, {'type': 'EXPERIMENTAL', 'label': 'Intraumbilical entry group', 'description': 'Umbilical port will be insert to intra umbilical area.', 'interventionNames': ['Procedure: Ten mm trocar']}, {'type': 'EXPERIMENTAL', 'label': 'Infraumbilical group', 'description': 'Umbilical port will be insert to infra umbilical area.', 'interventionNames': ['Procedure: Ten mm trocar']}], 'interventions': [{'name': 'Ten mm trocar', 'type': 'PROCEDURE', 'armGroupLabels': ['Infraumbilical group', 'Intraumbilical entry group', 'Supraumbilical entry group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34668', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Mehmet Baki Şentürk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mehmet Baki Senturk', 'investigatorAffiliation': 'Zeynep Kamil Maternity and Pediatric Research and Training Hospital'}}}}