Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2025-12-24 @ 4:17 PM
Study NCT ID:
NCT07006766
Status:
COMPLETED
Last Update Posted:
2025-06-05
First Post:
2025-05-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bucatini Pasta, Japanese Shirataki Konjac Noodles, and Artificial Vessels: In Search of the Ideal Low-cost Vessel Simulator for Microsurgical Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2025-05-27', 'studyFirstSubmitQcDate': '2025-05-27', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Perform Anastomosis', 'timeFrame': 'up to 30 min'}, {'measure': 'Number of Stitches', 'timeFrame': 'up to 30 min'}, {'measure': 'Patency (either Yes or No)', 'timeFrame': 'up to 30 min', 'description': "Patency is the condition of being 'open'."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microsuture', 'microsurgery', 'surgical training', 'microsurgical education', 'global', 'accessibility', 'noodle', 'synthetic', 'vessel', 'anastomosis', 'patency', 'education', 'outreach', 'low-cost', 'microsurgical simulation', 'simulation', 'vessel simulator'], 'conditions': ['Surgical Procedure, Unspecified']}, 'referencesModule': {'references': [{'pmid': '24603055', 'type': 'BACKGROUND', 'citation': 'Prunieres GJ, Taleb C, Hendriks S, Miyamoto H, Kuroshima N, Liverneaux PA, Facca S. Use of the Konnyaku Shirataki noodle as a low fidelity simulation training model for microvascular surgery in the operating theatre. Chir Main. 2014 Apr;33(2):106-11. doi: 10.1016/j.main.2013.12.003. Epub 2014 Feb 4.'}, {'pmid': '34291182', 'type': 'BACKGROUND', 'citation': 'Mohammad S, Hanstein R, Lo Y, Levy IM. Validating a Low-Fidelity Model for Microsurgical Anastomosis Training. JB JS Open Access. 2021 Jul 16;6(3):e20.00148. doi: 10.2106/JBJS.OA.20.00148. eCollection 2021 Jul-Sep.'}, {'pmid': '34915484', 'type': 'BACKGROUND', 'citation': 'Ng ZY, Honeyman C, Lellouch AG, Pandya A, Papavasiliou T. Smartphone-Based DIY Home Microsurgical Training with 3D Printed Microvascular Clamps and Japanese Noodles. Eur Surg Res. 2023;64(2):301-303. doi: 10.1159/000521439. Epub 2021 Dec 15.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the strengths and weaknesses of training models that are accessible, reproducible, and geared toward new learners. Specifically, the investigators aim to compare the four following models: Japanese shirataki konjac noodle, "Dragon skin" silicone vessel, standard silicone vessel, and the "blue-blood" chicken thigh model. This information will be valuable in assessing the utility of implementing a Japanese shirataki konjac noodle model in beginner microsurgical courses for both local and global education and outreach.', 'detailedDescription': 'The significant benefit Japanese shirataki konjac noodle as a model for microsurgical simulation training is that they are very cost effective and allow for acquisition of microsurgical skills in a low stake environment. This is particularly useful for the microsurgery novice to become familiar with the tools and basics of placing microsuture.\n\nIn this study, the evaluator will complete a "pre-exercise" survey online using a laptop in the microsurgical work space. The evaluator will be oriented to the work space and then attempt to perform an end-to-end anastomoses on each of the four models.\n\nThe following three measurements will be taken: time to perform anastomosis, number of stitches, and patency (Yes/No).\n\nFollowing these trials, the evaluator will take a "post-exercise" survey. This survey will obtain the evaluator\'s assessment of the models including most and least valuable aspects of each model, ease \\& comfort of placing a suture, and microsuture/microsurgical tool handling. Only one evaluator will be in the microsurgical lab space at one time. All study tasks will take approximately 1-2 hours. The individuals with no formal surgery/microsurgery education will be guided by an expert microsurgeon throughout the anastomoses. No varying instructional techniques will be assessed; all participants without formal training will receive identical guidance from the expert microsurgeon. The surgical residents will not need supervision or guidance. The training surgeries will not be offered if people are unable to take the research surveys.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Surgical residents or individual with no formal microsurgical education.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is able to commit 1-2 hours to the study.\n* Participants must either be a surgical resident or an individual with no formal surgery/microsurgery education. Five participants will be placed into each of these two categories.\n\nExclusion Criteria:\n\n* Participant is unable to commit 1-2 hours to the study.'}, 'identificationModule': {'nctId': 'NCT07006766', 'briefTitle': 'Bucatini Pasta, Japanese Shirataki Konjac Noodles, and Artificial Vessels: In Search of the Ideal Low-cost Vessel Simulator for Microsurgical Education', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Bucatini Pasta, Japanese Shirataki Konjac Noodles, and Artificial Vessels: In Search of the Ideal Low-cost Vessel Simulator for Microsurgical Education', 'orgStudyIdInfo': {'id': '2023-1534'}, 'secondaryIdInfos': [{'id': 'A539730', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Microsurgical training', 'description': 'Participants will complete pre-exercise surveys, attempt 4 microsurgical anastomoses, and complete post-exercise surveys.', 'interventionNames': ['Other: Microsurgical Training Models']}], 'interventions': [{'name': 'Microsurgical Training Models', 'type': 'OTHER', 'description': 'Four models will be compared: Japanese shirataki konjac noodle, "Dragon skin" silicone vessel, standard silicone vessel from Microsurgery and Regenerative Medicine (MSRM) lab, and the "blue-blood" chicken thigh model.', 'armGroupLabels': ['Microsurgical training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'UW School of Medicine and Public Health', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Samuel Poore, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UW School of Medicine and Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}