Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT05296967
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2022-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Efficience of Chewing-gum to Reduce the Duration of Postoperative Ileus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008409', 'term': 'Mastication'}], 'ancestors': [{'id': 'D004435', 'term': 'Eating'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D004068', 'term': 'Digestive System Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2022-03-06', 'studyFirstSubmitQcDate': '2022-03-16', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the efficiency of chewing gum in reducing the duration of POI. POI is defined by the criteria of Vather from the postoperative day 1 up to day 30', 'timeFrame': 'collected each day until the end of the POI, assessed up to day 21', 'description': 'The duration of POI is the time between the first day of meeting the criteria of Vather to the day of recovery of tolerance of solid food and of exoneration of stool and/or flatus (GI-3 recovery).\n\nPatients will be asked to report in their diary the day of tolerance of solid food and of exoneration of stool and/or flatus (GI-3 recovery) after the diagnosis of POI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Ileus']}, 'descriptionModule': {'briefSummary': 'Postoperative ileus (POI) is a serious complication after surgery. While it complicates all type of surgery, it is more frequent after abdominal surgery (especially bowel or colorectal surgery).\n\nMany studies aim to reduce the occurence of POI without efficiency. The aim of this study is to assess the efficiency of the vagal stimulation, by the mean of chewing, to reduce the duration of POI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing colorectal surgery or small bowel surgery\n* elective or in emergency\n* open surgery or laparoscopy\n* diagnosis of POI\n* indication of fasting or nasogastric tube placement\n\nExclusion Criteria:\n\n* contra-indication of chewing\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT05296967', 'acronym': 'CHEWIP', 'briefTitle': 'Study of the Efficience of Chewing-gum to Reduce the Duration of Postoperative Ileus', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Efficiency of Chewing-gum to Reduce the Duration Postoperative Ileus: a Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2021_A03140_41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chewing gum', 'description': 'POI patients are asked to chew 20 minutes x2/ day', 'interventionNames': ['Behavioral: chewing']}, {'type': 'NO_INTERVENTION', 'label': 'No chewing', 'description': 'POI patients receive no intervention'}], 'interventions': [{'name': 'chewing', 'type': 'BEHAVIORAL', 'description': 'patients are asked to chew chewing gum X 3/ day', 'armGroupLabels': ['Chewing gum']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'University Hospital aof Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Château-Gontier', 'country': 'France', 'facility': 'CH Château Gontier', 'geoPoint': {'lat': 47.82705, 'lon': -0.70512}}, {'city': 'Cholet', 'country': 'France', 'facility': 'CH Cholet', 'geoPoint': {'lat': 47.05893, 'lon': -0.87974}}, {'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'CHD Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'city': 'Laval', 'country': 'France', 'facility': 'CH Laval', 'geoPoint': {'lat': 48.07247, 'lon': -0.77019}}, {'city': 'Nantes', 'country': 'France', 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.', 'ipdSharing': 'YES', 'description': 'Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.', 'accessCriteria': 'The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Centre Hospitalier de Cholet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}