Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-01-13 @ 11:52 AM
Study NCT ID:
NCT03271606
Status:
UNKNOWN
Last Update Posted:
2017-09-05
First Post:
2017-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ERAS in Video-assisted Mediastinal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-02-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-01', 'studyFirstSubmitDate': '2017-08-23', 'studyFirstSubmitQcDate': '2017-09-01', 'lastUpdatePostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '15-item quality of recovery scale (QoR-15)', 'timeFrame': 'At preoperative vist', 'description': "This scale mainly reflects the patient's status"}, {'measure': '15-item quality of recovery scale (QoR-15)', 'timeFrame': 'At 24 hours after surgery', 'description': "This scale mainly reflects the patient's status"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Enhanced Recovery After Surgery']}, 'descriptionModule': {'briefSummary': 'This is a single center, randomized,single blind study to investigate the effectiveness of enhanced recovery regimen (ERAS) in patients undergoing Video-assisted Mediastinal Surgery. And we also going to compare the effectiveness of ERAS with that of traditional regimen in these patients.', 'detailedDescription': 'Compare to traditional measures, the ERAS protocal mainly includes:Good preoperative visit, shorten the fast time, minimumal invasive surgery procedures, fewer opioids and early movements after surgery. These items have been successfully used in colon cancer surgery, and we thus plan to investigate the effectiveness of these measures in mediastinal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients elective mediastinal surgery;\n* BMI 18-30 kg/m2.\n\nExclusion Criteria:\n\n* Patient refuse;\n* ASA≥3;\n* Patients allergic to used anesthetics (propofol,rocuronium), patients with liver and/or kidney and/or mental dysfunction.'}, 'identificationModule': {'nctId': 'NCT03271606', 'briefTitle': 'ERAS in Video-assisted Mediastinal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'The Clinical Study of ERAS Protocol in Video-assisted Mediastinal Surgery', 'orgStudyIdInfo': {'id': 'zs2017822'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ERAS group', 'description': 'The patients in this group receive enhanced measures perioperatively', 'interventionNames': ['Combination Product: ERAS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional group', 'description': 'The patients in this group receive traditional measures perioperatively', 'interventionNames': ['Combination Product: Traditional measures']}], 'interventions': [{'name': 'ERAS', 'type': 'COMBINATION_PRODUCT', 'description': 'The investigators mainly used enhanced measures perioperatively in mediastinal surgery as these used in other surgery', 'armGroupLabels': ['ERAS group']}, {'name': 'Traditional measures', 'type': 'COMBINATION_PRODUCT', 'description': 'The investigators mainly used traditional measures perioperatively in mediastinal surgery as these used in other surgery', 'armGroupLabels': ['Traditional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'chao liang, Ph.D', 'role': 'CONTACT', 'email': 'superwm226@aliyun.com', 'phone': '15921679955'}], 'facility': 'Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}