Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-27 @ 11:05 PM
Study NCT ID:
NCT01394094
Status:
UNKNOWN
Last Update Posted:
2011-07-14
First Post:
2011-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Gum Chewing on Recovery of Bowel Function Following Benign Gynecologic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-13', 'studyFirstSubmitDate': '2011-07-13', 'studyFirstSubmitQcDate': '2011-07-13', 'lastUpdatePostDateStruct': {'date': '2011-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first flatus', 'timeFrame': 'Up to 7 days after surgery'}], 'secondaryOutcomes': [{'measure': 'Incidence and severity of postoperative nausea, vomiting and abdominal discomfort', 'timeFrame': 'Up to 7 days after surgery'}, {'measure': 'Incidence of postoperative complications', 'timeFrame': 'Up to 7 days after surgery'}, {'measure': 'Time to first regular diet', 'timeFrame': 'Up to 7 days after surgery'}, {'measure': 'Time to first defecation', 'timeFrame': 'Up to 7 days after surgery'}, {'measure': 'Hospital stay', 'timeFrame': 'Up to 7 days after surgery'}, {'measure': "Patients's satisfaction", 'timeFrame': 'Up to 7 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gum chewing', 'Bowel function', 'benign gynecologic surgery'], 'conditions': ['Recovery of Bowel Function, Due to Gum Chewing']}, 'descriptionModule': {'briefSummary': 'Gum chewing can promotes the return bowel function after gynecologic surgery.', 'detailedDescription': "Following abdominal surgery for treatment of benign gynecologic surgery, paralytic ileus may be develops. Gum chewing can promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion. This study will be evaluate effects of adding gum chewing to the conventional postoperative feeding protocol on the return of bowel function, its related complication, and patients's satisfaction."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing abdominal surgery for benign gynecologic conditions at Maharaj Nakorn Chiang Mai hospital\n\nExclusion Criteria:\n\n* Perioperative hyperalimentation\n* Recent chemotherapy (within 3 weeks before surgery)\n* Previous bowel surgery\n* Inflammatory bowel disease\n* Previous abdominal or pelvic radiation\n* Need for immediate postoperative endotracheal intubation\n* Need for postoperative admission to intensive care unit\n* Undergoing emergency surgery with oral intake of fluid or food with in 4 hours before surgery'}, 'identificationModule': {'nctId': 'NCT01394094', 'briefTitle': 'Effects of Gum Chewing on Recovery of Bowel Function Following Benign Gynecologic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'Effects of Gum Chewing on Recovery of Bowel Function Following Benign Gynecologic Surgery: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '10OCT010402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gum Chewing', 'description': 'Gum chewing (30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in addition to conventional postoperative feeding schedule', 'interventionNames': ['Behavioral: Gum chewing']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional', 'description': 'Conventional postoperative feeding schedule'}], 'interventions': [{'name': 'Gum chewing', 'type': 'BEHAVIORAL', 'otherNames': ['Sugar free and calcium free gum'], 'description': 'Gum chewing(30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in the addition to conventional postoperative feeding schedule', 'armGroupLabels': ['Gum Chewing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Amphoe Muang', 'state': 'Chiang Mai', 'country': 'Thailand', 'contacts': [{'name': 'Manatsawee Manopunya, MD', 'role': 'CONTACT', 'email': 'Manatsawee.m@hotmail.com', 'phone': '66-89-6324916'}, {'name': 'Manatsawee Manopunya, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculty of Medicine, Chiang Mai University'}], 'centralContacts': [{'name': 'Manatsawee Manopunya, MD', 'role': 'CONTACT', 'email': 'manatsawee.m@hotmail.com', 'phone': '66-89-6324916'}], 'overallOfficials': [{'name': 'Manatsawee - Manopunya, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chiang Mai University, Thailand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Manatsawee Manopunya', 'oldOrganization': 'Chiang Mai University'}}}}