Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2026-01-01 @ 12:36 AM
Study NCT ID:
NCT03408795
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2018-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Surgical Skills of Trainees in Learning the LDG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-31', 'studyFirstSubmitDate': '2018-01-08', 'studyFirstSubmitQcDate': '2018-01-23', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing the development of surgical skill by JORS-DG in the initial experience of LDG.', 'timeFrame': 'Participants will be followed for the duration of the educational study for 3 years.', 'description': 'The surgical skill and performance of LDG was scored using JORS-DG by a trainee and an instructor. The difference in mean surgical performance score of JORS-DG was evaluated in tree phase. The score about JORS-DG is evaluated on a three or two level scale ( 28items in B-1 reconstruction or 31items in R-Y reconstruction). Maximum of total score is 46 in B-1 reconstruction or 52 in R-Y reconstruction. High score is good surgical skill. Low score is poor surgical skill.'}], 'secondaryOutcomes': [{'measure': 'Assessing the value of surgical skill by JORS-DG in the initial experience of LDG and surgical outcome.', 'timeFrame': 'Participants will be followed for the duration of the educational study for 3 years.', 'description': 'Operation time, bleeding , Postoperative complications are compared with average of total score of JORS-LDG. The score about JORS-LDG is evaluated on a three or two level scale ( 28items in B-1 reconstruction or 31items in R-Y reconstruction). Maximum of total score is 46 in B-1 reconstruction or 52 in R-Y reconstruction. High score is good surgical skill. Low score is poor surgical skill.'}, {'measure': 'Assessing the value of surgical skill by JORS-DG in the initial experience of LDG and surgical outcome.', 'timeFrame': 'Participants will be followed for the duration of the educational study for 3 years.', 'description': "Procedures' time in each items of LDG was evaluated for difficulty of surgical technics. The scoring rates in each items of LDG are compared with Procedures' time. The average of score about JORS-LDG is evaluated on a three or two level scale ( 28items in B-1 reconstruction or 31items in R-Y reconstruction). High score is good surgical skill. Low score is poor surgical skill."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastrostomy', 'Surgical Procedure, Unspecified', 'Assessment, Self']}, 'descriptionModule': {'briefSummary': 'Laparoscopic distal gastrectomy (LDG) is a common surgery in the surgical trainees. However, there is no assessment system to measuring the surgical skill of surgical trainees. The novel surgical assessment system, which called Japanese Operative Rating Scale for Laparoscopic Distal Gastrectomy (JORS-LDG) by the task analysis and the Delphi method have been developed. This study describes assessing the development of surgical skill by JORS-LDG in the initial experience of LDG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Laparoscopic distal gastrectomy to early gastric cancer\n* D1 plus or D2 lymphadenectomy\n* Provide signed informed consent\n\nExclusion Criteria:\n\n* postoperative conditions affecting LDG\n* pregnancy\n* advanced gastric cancer\n* D1 lymphadenectomy\n* Total or subtotal gastrectomy\n* unsuitable condition'}, 'identificationModule': {'nctId': 'NCT03408795', 'briefTitle': 'Assessing the Surgical Skills of Trainees in Learning the LDG', 'organization': {'class': 'OTHER', 'fullName': 'Nagasaki University'}, 'officialTitle': 'Assessing the Surgical Skills of Trainees in Learning the Laparoscopic Distal Gastrectomy', 'orgStudyIdInfo': {'id': '15122118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'JORS-LDG Group', 'description': 'Participants in JORS-LDG Group score the performance of procedure after LDG.', 'interventionNames': ['Procedure: Laparoscopic distal gastrectomy']}], 'interventions': [{'name': 'Laparoscopic distal gastrectomy', 'type': 'PROCEDURE', 'description': 'Longitudinal testing of The Japanese Operative Rating Scale for Laparoscopic Distal Gastrectomy', 'armGroupLabels': ['JORS-LDG Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '852-8501', 'city': 'Nagasaki', 'country': 'Japan', 'facility': 'Nagasaki University Hospital', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nagasaki University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hokkaido University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Department of Surgery', 'investigatorFullName': 'Kobayashi Shinichiro', 'investigatorAffiliation': 'Nagasaki University'}}}}