Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-30 @ 6:39 PM
Study NCT ID:
NCT04970732
Status:
COMPLETED
Last Update Posted:
2021-07-21
First Post:
2021-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Chewing Gum on Abdominal Distension in Patients After Lumbar Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055009', 'term': 'Spondylosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal 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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-20', 'studyFirstSubmitDate': '2021-07-01', 'studyFirstSubmitQcDate': '2021-07-20', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical examination', 'timeFrame': 'After surgery to discharge, an average of 4 days', 'description': 'Number of bowel sounds'}, {'measure': 'Time points', 'timeFrame': 'After surgery to discharge, an average of 4 days', 'description': 'First anal exhaust time, first defecation time'}, {'measure': 'Medication', 'timeFrame': 'After surgery to discharge, an average of 4 days', 'description': 'Whether the medication for exhaust and defecation is used. If used, what kind of medicine and the dosage of the medicine.'}, {'measure': 'Incidence of abdominal distension', 'timeFrame': 'After surgery to discharge, an average of 4 days', 'description': 'Incidence of abdominal distension'}], 'secondaryOutcomes': [{'measure': 'Oral comfort', 'timeFrame': 'After surgery to discharge, an average of 4 days', 'description': 'Whether the oral comfort is applied.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lumbar degenerate diseases', 'Postoperative management', 'Abdominal distension'], 'conditions': ['Lumbar Spondylosis']}, 'descriptionModule': {'briefSummary': 'According to chewing gum can promote the recovery of gastrointestinal function, it is used as an intervention measure for patients after lumbar surgery to evaluate the effect of chewing gum on improving abdominal distension of patients after lumbar surgery, so as to provide basis for the application and promotion of chewing gum in lumbar postoperative nursing', 'detailedDescription': 'In this study, the patients after lumbar surgery were given chewing gum after anesthesia. The exhaust time, defecation time and the incidence of abdominal distension of the two groups were compared, and the significance of chewing gum in improving abdominal distension after lumbar surgery was discussed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subjects aged 18 years or above were able to chew together;\n* Good at listening, speaking, reading and writing;\n* Lumbar degenerative disease was definitely diagnosed;\n* General anesthesia was used;\n* Methods: posterior lumbar decompression, bone graft fusion and internal fixation;\n* No history of gum allergy;\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04970732', 'briefTitle': 'Effect of Chewing Gum on Abdominal Distension in Patients After Lumbar Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'A Randomized Controlled Study to Evaluate the Effectiveness of Chewing Gum in Improving Abdominal Distension After Lumbar Spine Surgery', 'orgStudyIdInfo': {'id': 'M2018051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'The patients in the experimental group returned to the ward for general anesthesia, started to wake up for 2 hours, chewed xylitol gum, and the professional nurses distributed it on time every 2 hours on the operation day, then 3 times / day, 15-20 minutes / time, 2 tablets / time. Body position: lateral position. The first anal exhaust stop chewing, normal sleep at night (8 p.m.), do not chew gum. Gum waste must be identified', 'interventionNames': ['Procedure: Gum chewing']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group received routine nursing after surgery.'}], 'interventions': [{'name': 'Gum chewing', 'type': 'PROCEDURE', 'description': 'The patients in the experimental group returned to the ward for general anesthesia, started to wake up for 2 hours, chewed xylitol gum, and the professional nurses distributed it on time every 2 hours on the operation day, then 3 times / day, 15-20 minutes / time, 2 tablets / time. Body position: lateral position. The first anal exhaust stop chewing, normal sleep at night (8 p.m.), do not chew gum. Gum waste must be identified', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}