Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-01-05 @ 5:36 AM
Study NCT ID:
NCT04461067
Status:
UNKNOWN
Last Update Posted:
2022-07-28
First Post:
2020-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastric Volume and Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-27', 'studyFirstSubmitDate': '2020-06-24', 'studyFirstSubmitQcDate': '2020-07-03', 'lastUpdatePostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diameter of the gastric antrum', 'timeFrame': 'immediately before the procedure and each postoperative day up to discharge (mean 7 days)'}], 'secondaryOutcomes': [{'measure': 'postoperative ileus', 'timeFrame': 'in the morning up to 30 postoperative days'}, {'measure': 'Postoperative quality of life: GIQLI', 'timeFrame': 'before discharge', 'description': 'GIQLI'}, {'measure': 'postoperative morbidity', 'timeFrame': 'within 30 postoperative days', 'description': 'Dindo Clavien Scale (from 1 (minor) to 5 (death))'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Ileus']}, 'descriptionModule': {'briefSummary': 'Postoperative ileus (POI) is a serious complication after colorectal surgery. One of its most frequent consequences is the replacement of nasogastric tube because of the vomiting. Vomiting is due to the distension of the stomach and information on the evolution of gastric filling after surgery could help to better understand the physiopathology of POI. It could also give indication to help the physician in the management of POI.\n\nThe ultrasonography has been shown to be a reliable technic to assess the gastric emptying.\n\nTo date, there is no indication in the literature about the evolution of the gastric filling after colorectal surgery while these information could help to identify patients at risk for POI and to predict the need for POI replacement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient undergoing colorectal resection whatever the surgical access\n\nExclusion Criteria:\n\n* contra-indication to ultrasonography performance\n* history of gastrectomy'}, 'identificationModule': {'nctId': 'NCT04461067', 'acronym': 'EVOL', 'briefTitle': 'Gastric Volume and Colorectal Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Ultrasonographic Evaluation of the Evolution of the Gastric Volume After Colorectal', 'orgStudyIdInfo': {'id': '19.12.02.56807'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gastric antrum measurement', 'interventionNames': ['Diagnostic Test: ultrasonography']}], 'interventions': [{'name': 'ultrasonography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ultrasonography of the stomach is performed to measure the diameter of the antrum', 'armGroupLabels': ['Gastric antrum measurement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aurélien VENARA', 'role': 'CONTACT'}], 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'centralContacts': [{'name': 'aurélien venara, MD, PhD', 'role': 'CONTACT', 'email': 'auvenara@chu-angers.fr', 'phone': '0033241353618'}], 'overallOfficials': [{'name': 'Aurélien VENARA, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Angers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}