Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-03-08 @ 1:47 AM
Study NCT ID:
NCT03046303
Status:
UNKNOWN
Last Update Posted:
2017-02-08
First Post:
2017-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radical Gastrectomy Within Enhanced Recovery Programs(ERAS): a Prospective Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2019-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-05', 'studyFirstSubmitDate': '2017-02-02', 'studyFirstSubmitQcDate': '2017-02-05', 'lastUpdatePostDateStruct': {'date': '2017-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical parameters', 'timeFrame': 'One week after operation', 'description': 'length of post-operative stay'}], 'secondaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': '30 days after operation', 'description': 'wound infection;post-opeartion bleeding;ileus;stenosis;leakage'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ERAS,gastric cancer'], 'conditions': ['Gastrostomy Complications']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, single-center, randomized controlled trial. The study protocol was approved by the Ethics Committee at the First Hospital of Jilin University.ERAS is combined with the laprascopic gastrectomy to assess the efficacy and safety in patients with advanced gastric carcinoma.The hospitalized patients were randomly divided into ERAS group and conventional pathway group . Inter-group differences were evaluated for clinical recovery index, economic indicators, length of hospital stay, 3 years to 5 years long-term survival, etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) A preoperative cancer stage of T2, T3, T4, Any N, M0 without digestive obstruction confirmed by whole body CT scan, which could be treated with laparoscopic gastrectomy; (2) age 18-75 years; (3) pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy; (4) normal hematological, renal, hepatic, and cardiac parameters, ASA score \\< III without severe systemic disease; and (5) no history of treatment with neoadjuvant chemotherapy and/or radiotherapy.\n\nExclusion Criteria:\n\n* patients requiring conversion to open gastrectomy; excessive bleeding (˃ 500 mL);and patients opting out of the study.'}, 'identificationModule': {'nctId': 'NCT03046303', 'briefTitle': 'Radical Gastrectomy Within Enhanced Recovery Programs(ERAS): a Prospective Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': 'Radical Gastrectomy Within Enhanced Recovery Programs: a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ERAS for Radical gastrectomy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ERAS group', 'description': 'Patients were admitted 1-3 days prior to their respective dates of operation. A ERAS protocol was used in the ERAS group.', 'interventionNames': ['Procedure: ERAS']}, {'type': 'NO_INTERVENTION', 'label': 'conventional pathway group', 'description': 'The conventional pathway group received conventional care.'}], 'interventions': [{'name': 'ERAS', 'type': 'PROCEDURE', 'description': 'optimized pain control, restricted I.V. fluids, early initiation of post-operative oral feeding and enforced mobilization', 'armGroupLabels': ['ERAS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Quan Wang, MD', 'role': 'CONTACT', 'email': 'wangquan5607@126.com', 'phone': '+86-431-81875607'}], 'facility': 'First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'centralContacts': [{'name': 'Quan Wang, MD', 'role': 'CONTACT', 'email': 'wangquan5607@126.com', 'phone': '+86-431-81875607'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}