Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-25 @ 7:52 PM
Study NCT ID:
NCT05600335
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2022-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short-term Outcomes of ERAS Protocol in RAME for Esophageal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2022-10-26', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to first flatus', 'timeFrame': '2019-2022', 'description': 'time to first flatus characterized by postoperative outcome'}, {'measure': 'time to out-of-bed activity', 'timeFrame': '2019-2022', 'description': 'time to out-of-bed activity characterized by postoperative outcome'}, {'measure': 'time to liquid diet', 'timeFrame': '2019-2022', 'description': 'time to liquid diet characterized by postoperative outcome'}, {'measure': 'postoperative pain score', 'timeFrame': '2019-2022', 'description': "postoperative pain score characterized by postoperative outcome and was scored according to the numeric pain rating scale (NPRS) to assess the patient's pain on the first day after surgery."}, {'measure': 'duration of analgesic pump', 'timeFrame': '2019-2022', 'description': 'duration of analgesic pump characterized by postoperative outcome'}, {'measure': 'postoperative hospital stay', 'timeFrame': '2019-2022', 'description': 'postoperative hospital stay characterized by postoperative outcome'}, {'measure': 'ICU length of stay', 'timeFrame': '2019-2022', 'description': 'ICU length of stay characterized by postoperative outcome'}, {'measure': 'in-hospital mortality', 'timeFrame': '2019-2022', 'description': 'in-hospital mortality characterized by postoperative outcome'}, {'measure': 'incidence of various postoperative complications', 'timeFrame': '2019-2022', 'description': 'incidence of various postoperative complications characterized by postoperative outcome'}], 'secondaryOutcomes': [{'measure': 'postoperative chest drainage volume', 'timeFrame': '2019-2022', 'description': 'postoperative chest drainage volume characterized by postoperative outcome'}, {'measure': 'preoperative anesthesia time', 'timeFrame': '2019-2022', 'description': 'preoperative anesthesia time characterized by intraoperative outcome'}, {'measure': 'operation time', 'timeFrame': '2019-2022', 'description': 'operation time characterized by intraoperative outcome'}, {'measure': 'blood loss', 'timeFrame': '2019-2022', 'description': 'blood loss characterized by intraoperative outcome'}, {'measure': 'conversion rate', 'timeFrame': '2019-2022', 'description': 'conversion rate characterized by intraoperative outcome'}, {'measure': 'radicality of surgery', 'timeFrame': '2019-2022', 'description': 'R0 resection was defined as \\> 1mm from all resection margins, R1 resection was defined as microscopic residual tumor, and R2 resection was defined as macroscopic residual tumor'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Cancer Patients']}, 'descriptionModule': {'briefSummary': 'This single-center, retrospective cohort study aimed to evaluate the short-term outcomes of enhanced recovery after surgery (ERAS) protocol in perioperative robotic-assisted McKeown esophagectomy (RAME) among esophageal cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with esophageal cancer undertaking resection by RAME were included. According to different perioperative management strategies, all eligible patients were divided into the ERAS group and conventional group.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. first detected and endoscopically confirmed esophageal cancer;\n2. preoperative evaluation showed no distant metastases and suitable for RAME;\n3. preoperative clinical stage of I to III;\n\nExclusion Criteria:\n\n1. patients had a history of thoracic or abdominal surgery;\n2. patients were IV to VI in the American Society of Anesthesiologists (ASA) physical status classification system;\n3. patients had other malignancies;\n4. patients had missing clinical data'}, 'identificationModule': {'nctId': 'NCT05600335', 'briefTitle': 'Short-term Outcomes of ERAS Protocol in RAME for Esophageal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Short-term Outcomes of Enhanced Recovery After Surgery Protocol in Robotic-assisted McKeown Esophagectomy for Esophageal Cancer', 'orgStudyIdInfo': {'id': 'HXDB-1908'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ERAS group', 'interventionNames': ['Procedure: ERAS protocol']}, {'label': 'Conventional group', 'interventionNames': ['Procedure: ERAS protocol']}], 'interventions': [{'name': 'ERAS protocol', 'type': 'PROCEDURE', 'description': 'Patients with esophageal cancer have undergone RAME using ERAS protocol and conventional management strategy', 'armGroupLabels': ['Conventional group', 'ERAS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610000', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Yidan Lin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'West China Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jiajun Xiong', 'investigatorAffiliation': 'West China Hospital'}}}}