Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2025-12-25 @ 11:57 AM
Study NCT ID:
NCT03945461
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2019-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Return of Bowel Function After One or Two Level Anterior Lumbar Interbody Fusion With Chewing Gum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055009', 'term': 'Spondylosis'}, {'id': 'D013168', 'term': 'Spondylolisthesis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013169', 'term': 'Spondylolysis'}]}, '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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2019-04-04', 'studyFirstSubmitQcDate': '2019-05-09', 'lastUpdatePostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in bowel pattern based on gum-chewing', 'timeFrame': '24 hours after surgery', 'description': 'Number of hours until return of bowel sounds'}], 'secondaryOutcomes': [{'measure': 'Bowel function', 'timeFrame': 'Number of hours from admission to discharge up to 48 hours', 'description': 'Number of hours until return of flatus'}, {'measure': 'Length of time to return of bowel function after anterior lumbar interbody fusion', 'timeFrame': 'Number of hours from admission to discharge up to 48 hours', 'description': 'Number of hours until complete bowel movement'}, {'measure': 'Total length of hospital', 'timeFrame': 'Number of hours from admission to discharge up to 48 hours', 'description': 'Number of hours of hospital stay'}, {'measure': 'Pain score', 'timeFrame': '24 hours post-operatively', 'description': 'On a scale of 0 (zero pain) and 10 (worst pain)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spondylosis', 'Spondylolisthesis', 'Neurogenic Claudication', 'Foraminal Stenosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are trying to identify is chewing gum improves bowel function after anterior lumbar interbody fusion', 'detailedDescription': "Aims, purpose, or objectives:\n\n1. Observe changes in bowel pattern based on gum-chewing\n2. Examine bowel function after anterior lumbar interbody fusion\n3. Measure length of time to return of bowel function after anterior lumbar interbody fusion\n4. Compare return of bowel function in patients who chew gum and patients standardized to usual post-operative care\n5. Measure the hospital length of stay amongst study groups\n6. Measure post-operative pain amongst study groups\n\nBackground (Include relevant experience, gaps in current knowledge, preliminary data, etc.):\n\nOne or two level anterior lumbar interbody fusions are designed to correct lumbar spondylosis and spondylolisthesis, which can cause debilitating back and leg pain. This surgery involves an anterior approach, which often requires displacement of bowel for the length of the surgery. Patients frequently have a slow return of bowel function secondary to anesthetic time, opioid use, and primarily due to the bowel displacement intraoperatively. Because this is a one or two level surgery, many patients would benefit from same-day discharge but often remain inpatient several days due to slow return of bowel function.\n\nGum chewing has been shown to decrease the time for return to bowel function (RBF) in colorectal and gynecology patients postoperatively.\n\nGum chewing and RBF has been studied in the spine population for posterior operations but not anterior spine surgery. This study aims to identify whether chewing gum has an impact on patient's report of pain, RBF, length of stay, and subjective report of satisfaction post-operatively. This could be an outpatient operation; however, pain and RBF often prevent patients from discharging home the same day of surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Undergoing one or two level anterior lumbar interbody fusion\n2. Diagnosis of spondylosis, spondylolisthesis, revision of foraminal stenosis or neurogenic claudication\n\nExclusion Criteria:\n\n1. Previous bowel surgery\n2. Diagnosis of an inflammatory bowel disease\n3. Allergy to xylitol\n4. Pregnancy\n\nSome participants may subsequently undergo a posterior spinal fusion on the same-day of surgery. They will not be excluded, but the investigators will include this group in a different data subset.'}, 'identificationModule': {'nctId': 'NCT03945461', 'briefTitle': 'Return of Bowel Function After One or Two Level Anterior Lumbar Interbody Fusion With Chewing Gum', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Return of Bowel Function After One or Two Level Anterior Lumbar Interbody Fusion With Chewing Gum', 'orgStudyIdInfo': {'id': '18-011849'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gum chewing', 'description': 'Chew xylitol based, peppermint flavored gum for 30 minutes every two hours during the hours of 7 am to 9 pm, for the first 24 hours after your surgery', 'interventionNames': ['Other: Chewing gum']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'Standard hospital management with no deviations from usual care'}], 'interventions': [{'name': 'Chewing gum', 'type': 'OTHER', 'description': 'xylitol based, peppermint flavored gum', 'armGroupLabels': ['Gum chewing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Maziyar Kalani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Neurosurgeon', 'investigatorFullName': 'Maziyar A. Kalani', 'investigatorAffiliation': 'Mayo Clinic'}}}}