Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2026-02-24 @ 2:30 PM
Study NCT ID:
NCT04834661
Status:
COMPLETED
Last Update Posted:
2022-04-18
First Post:
2021-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performing Laparoscopic Surgery for Colorectal and Gastric Cancer Outside the Primary Registered Medical Institution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-15', 'studyFirstSubmitDate': '2021-04-04', 'studyFirstSubmitQcDate': '2021-04-04', 'lastUpdatePostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall postoperative complication rate', 'timeFrame': '30 days after surgery', 'description': 'postoperative complications evaluated according to Clavin-Dindo classification'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'This study investigates the safety and feasibility of performing laparoscopic surgery for colorectal and gastric cancer inside versus outside the primary registered medical institution under multi-sites practice (MSP) policy. This is a single practitioner, retrospective comparative study. The endpoints are peri-operative outcomes, pathological results, and medical costs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'colorectal cancer and gastric cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 100 years\n* diagnosed as colorectal cancer or gastric cancer\n* undergoing laparoscopic surgery between 2016-2020 performed by Dr Feng\n\nExclusion Criteria:\n\n* Emergency procedure\n* without histopathological result of malignancy\n* conventional open surgery'}, 'identificationModule': {'nctId': 'NCT04834661', 'briefTitle': 'Performing Laparoscopic Surgery for Colorectal and Gastric Cancer Outside the Primary Registered Medical Institution', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Minimally Invasive Surgery Center'}, 'officialTitle': 'Safety and Feasibility of Performing Laparoscopic Surgery for Colorectal and Gastric Cancer Outside the Primary Registered Medical Institution Under Multi-sites Practice (MSP) Policy, a Retrospective Comparative Study', 'orgStudyIdInfo': {'id': 'multi-sites practice surgery'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'inside group', 'description': 'laparoscopic surgery for colorectal and gastric cancer inside the primary registered medical institution', 'interventionNames': ['Other: surgery inside the primary institution']}, {'label': 'outside group', 'description': 'laparoscopic surgery for colorectal and gastric cancer outside the primary registered medical institution', 'interventionNames': ['Other: surgery outside the primary institution']}], 'interventions': [{'name': 'surgery inside the primary institution', 'type': 'OTHER', 'description': 'to perform laparoscopic surgery for colorectal and gastric cancer inside the primary registered medical institution', 'armGroupLabels': ['inside group']}, {'name': 'surgery outside the primary institution', 'type': 'OTHER', 'description': 'to perform laparoscopic surgery for colorectal and gastric cancer outside the primary registered medical institution', 'armGroupLabels': ['outside group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200020', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Zhenghao Cai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Minimally Invasive Surgery Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending surgeon of gastrointestinal surgery，Ruijin Hospital, Shanghai Jiaotong University School of Medicine', 'investigatorFullName': 'Cai Zhenghao', 'investigatorAffiliation': 'Shanghai Minimally Invasive Surgery Center'}}}}