Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:59 PM
Study NCT ID:
NCT04768660
Status:
UNKNOWN
Last Update Posted:
2021-02-24
First Post:
2021-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Chewing Gum Against Postoperative Ileus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002638', 'term': 'Chewing Gum'}], 'ancestors': [{'id': 'D053149', 'term': 'Plant Gums'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D053147', 'term': 'Plant Exudates'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D002182', 'term': 'Candy'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-02-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-21', 'studyFirstSubmitDate': '2021-02-21', 'studyFirstSubmitQcDate': '2021-02-21', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First flatus after surgery', 'timeFrame': '(with in the first 21 days)', 'description': 'From day of surgery until first postoperative flatus'}, {'measure': 'Length of hospital stay', 'timeFrame': '(with in the first 21 days) ]', 'description': 'Time Frame: From day of surgery until discharge from surgical ward'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreas Neoplasm']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the use of chewing gum effects postoperative ileus after pancreaticoduodenectomy', 'detailedDescription': 'Postoperative ileus is common after surgery. One non-pharmacological intervention that has shown promising results in reducing the duration of postoperative ileus is chewing gum after surgery. However, this has not been investigated in upper gastrointestinal surgery such as pancreatic surgery. Hence the aim of this study was to investigate the effects of chewing gum treatment on patients undergoing pancreaticoduodenectomy due to pancreatic or periampullary cancer.\n\nThis study was conducted as a phase-III trial. Patients diagnosed with pancreatic tumours scheduled for pancreaticoduodenectomy were included. The treatment group received chewing gum postoperatively and standard care. Controls received glucose solution and standard care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pancreatic or periampullary cancer and scheduled to undergo pancreaticoduodenectomy.\n\nExclusion Criteria:\n\n* 2\\. Ongoing treatment for mental disease 3. Diagnosed neurological injuries or diseases affecting the ability to swallow or gastric function 4. Ongoing abuse of alcohol or other drugs 5. Previously known allergies to the content of chewing gum 6. Additional surgery after primary surgery.'}, 'identificationModule': {'nctId': 'NCT04768660', 'briefTitle': 'Effects of Chewing Gum Against Postoperative Ileus', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Use of Non-pharmacological Agent to Accelerate Gastrointestinal Recovery in Patients Undergoing Pancreatic Head Resection', 'orgStudyIdInfo': {'id': 'chewing gum postoperative'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'normal', 'description': 'people will not use chewing gums after whipple operation', 'interventionNames': ['Other: gum']}], 'interventions': [{'name': 'gum', 'type': 'OTHER', 'description': 'Other: Chewing gum ChiczaTM organic chewing gum 6 pieces a day Other: Glucose 12ml glucose solution (13,6g) per day', 'armGroupLabels': ['normal']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'andrew mokbel', 'role': 'CONTACT', 'email': 'andrew.sawers55@gmail.com', 'phone': '01090981160'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'andrew mokbel mahani sawers', 'investigatorFullName': 'Andrew Mokbel', 'investigatorAffiliation': 'Assiut University'}}}}