Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 5:09 AM
Study NCT ID:
NCT07063069
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-03
First Post:
2025-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Value of Ultrasound Measurement of Stomach Diameter in Predicting Postoperative Nausea/Vomiting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2025-06-12', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the sensitivity and specificity of the diagnostic character of the gastric diameter ratio at Day 2 / Day 0', 'timeFrame': 'Day 2/Day 0 after surgical intervention', 'description': 'Postoperative ileus is defined according to the Vather et al. criteria.'}], 'secondaryOutcomes': [{'measure': 'assess the sensitivity and specificity of the gastric diameter ratio at D2/D0 in predicting the onset of inhalation pneumonitis', 'timeFrame': 'Day 2/Day 0 after surgical intervention', 'description': 'the onset of inhalation pneumonitis, defined as a cough with varying degrees of fever secondary to surgery. Inhalation pneumonitis is clinically suspected and confirmed on imaging with a standard chest X-ray'}, {'measure': 'code a computer program to automatically measure the diameter of the gastric antrum', 'timeFrame': 'Day 2/Day 0 after surgical intervention', 'description': 'Gastric antrum diameter measurements and images'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patient With Indication for Major Abdominal Submesocolic, Parietal, Left Pancreatic or Liver Surger']}, 'descriptionModule': {'briefSummary': "The advent of enhanced rehabilitation after surgery has helped to reduce surgical stress, thereby improving postoperative outcomes by reducing the time it takes for patients to recover their transit and autonomy.\n\nDespite this, some 10-30% of patients undergoing abdominal surgery will experience postoperative ileus or nausea/vomiting. In addition to increasing the length of hospital stay, these complications increase patient discomfort and, above all, the risk of inhalation pneumonitis.\n\nWith the advent of enhanced rehabilitation, patients are receiving less drainage, particularly nasogastric drainage, which is now virtually outlawed in scheduled sub-mesocolic abdominal surgery.\n\nIn a recent international multicenter study of patients undergoing colorectal surgery, the authors reported that less than 10% of patients received a nasogastric tube routinely, and that 20% received it for clinical reasons (before or after nausea/vomiting). The authors also reported an overall inhalation pneumonitis rate of 4.2%. The authors concluded from this study that nasogastric tubes should not be inserted routinely, but that delay in nasogastric tube insertion was a risk factor for pneumopathy.\n\nAs the onset of postoperative pneumopathy is associated with a risk of mortality, it seems important to predict its risk of onset in order to target patients who could benefit from early nasogastric tube placement.\n\nA recent study carried out in the visceral surgery department of the CHU d'Angers evaluated the evolution of gastric distension. One of the objectives of the ancillary study was to evaluate the interest of the ratio of gastric antrum distension measurement in 2 axes (longitudinal and axial) at D2 postoperative / D preoperative.\n\nAs this was an ancillary study of a preliminary study, the number of events was 12, making it impossible to assert with high power that the appearance of nausea/vomiting is linked to the ratio described above. An observational study including more patients is therefore needed to confirm this hypothesis before carrying out a randomized controlled trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major patient\n* Indication for major abdominal surgery (submesocolic, parietal, left pancreas or liver)\n* Patient affiliated to or benefiting from a social security scheme\n\nNon-inclusion criteria\n\n* Patient refusal to participate in study\n* Need for immediate post-operative ICU stay\n* Surgery performed as an emergency\n* Esophageal, gastric or cephalic pancreatic surgery\n* Person deprived of liberty by judicial or administrative decision\n* Person under compulsory psychiatric care\n\nExclusion Criteria:\n\n* Discharge with nasogastric tube\n* Immediate admission to post-operative intensive care unit'}, 'identificationModule': {'nctId': 'NCT07063069', 'acronym': 'EVOL2', 'briefTitle': 'Evaluation of the Value of Ultrasound Measurement of Stomach Diameter in Predicting Postoperative Nausea/Vomiting', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Evaluation of the Value of Ultrasound Measurement of Stomach Diameter in Predicting Postoperative Nausea/Vomiting', 'orgStudyIdInfo': {'id': '49RC24_0252'}, 'secondaryIdInfos': [{'id': '2025-A00733-46', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abdominal ultrasound', 'description': 'All patients included will have an abdominal ultrasound scan', 'interventionNames': ['Other: Abdominal ultrasound']}], 'interventions': [{'name': 'Abdominal ultrasound', 'type': 'OTHER', 'description': 'All patients included will have an abdominal ultrasound scan to mesure anterior/posterior external diameter of gastric antrum upstream of pyloru and external diameter upper/lower of gastric antrum upstream of pylorus', 'armGroupLabels': ['Abdominal ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'contacts': [{'name': 'Jean-Baptiste Philippe, MD', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'drci-promotion-interne@chu-angers.fr'}], 'facility': 'University Hospital of Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'centralContacts': [{'name': 'Jean-Baptiste Philippe, MD', 'role': 'CONTACT', 'email': 'JeanBaptiste.Philippe@chu-angers.fr', 'phone': '0241353618', 'phoneExt': '+33'}, {'name': 'Aurelien Venara, MD, PhD', 'role': 'CONTACT', 'email': 'auvenara@chu-angers.fr', 'phone': '0241353618', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}