Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT00879294
Status:
WITHDRAWN
Last Update Posted:
2017-11-06
First Post:
2009-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Gum Chewing on Postoperative Ileus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'lastUpdateSubmitDate': '2017-11-02', 'studyFirstSubmitDate': '2009-04-09', 'studyFirstSubmitQcDate': '2009-04-09', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to resolution of post-operative ileus.', 'timeFrame': '1-14 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Perforated appendicitis', 'Ruptured appendicitis', 'Acute appendicitis with perforation'], 'conditions': ['Perforated Appendicitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if chewing gum after surgery for perforated appendicitis will shorten the time of intestinal dysfunction.', 'detailedDescription': 'After operations for a ruptured appendix, children are usually not allowed to eat or drink anything. This is because the infection inside the abdomen and the manipulation of the intestines during the operation cause the bowels to stop their normal movement. The resulting lack of bowel function is called an "ileus". When this occurs, intestinal secretions and anything taken in by mouth can become backed up, causing bloating, abdominal pain, nausea and vomiting. Children are not allowed to eat or drink anything during this time and require fluid hydration through an IV or even nutrition through an IV. This ileus usually lasts an average of 4-5 days, and can sometimes delay the discharge of children who are otherwise ready to go. The purpose of this research study is to determine if simple things, like gum chewing or anti-motion sickness bracelets can help speed the time it takes for the bowels to begin working after an operation for a ruptured appendix. Because the gum is not swallowed, it does not have the same effects as eating and drinking would on someone with an ileus. The same is true for the anti-motion sickness bracelets. Yet, it is thought that the chewing action from gum may stimulate the intestines into thinking that food is on the way and cause them to start working sooner than they otherwise might. The same may be true for the bracelets, and some studies show them to be helpful with nausea after surgery. Nevertheless, the effects of a bracelet on postoperative ileus are unproven.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any child who has undergone appendectomy for perforated appendicitis\n\nExclusion Criteria:\n\n* age less than or equal to 5 years\n* unable to chew gum safely\n* interval appendectomy'}, 'identificationModule': {'nctId': 'NCT00879294', 'briefTitle': 'The Effect of Gum Chewing on Postoperative Ileus', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'The Effect of Gum Chewing on Postoperative Ileus', 'orgStudyIdInfo': {'id': 'CR1_IRB00005677'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': '1 Wristband', 'description': 'Some patients will be randomized to wear a motion sickness wristband which does not have any drug effect.', 'interventionNames': ['Device: Motion sickness wristband']}, {'type': 'EXPERIMENTAL', 'label': 'Chewing Gum', 'description': 'Patients will be randomized to use chewing gum after surgery.', 'interventionNames': ['Dietary Supplement: Chewing Gum']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual post-operative care.'}], 'interventions': [{'name': 'Motion sickness wristband', 'type': 'DEVICE', 'description': 'No drugs are involved.', 'armGroupLabels': ['1 Wristband']}, {'name': 'Chewing Gum', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients will be asked to chew gum for 20 minutes, four times daily.', 'armGroupLabels': ['Chewing Gum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': "Brenner Children's Hospital", 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Thomas Pranikoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}