Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-01-17 @ 12:29 AM
Study NCT ID:
NCT01879605
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2013-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study About Effect of Preoperative Bowel Preparation Versus no Bowel Preparation Before Spinal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D045823', 'term': 'Ileus'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013012', 'term': 'Sorbitol'}, {'id': 'D001726', 'term': 'Bisacodyl'}], 'ancestors': [{'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003408', 'term': 'Cresols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2013-06-13', 'studyFirstSubmitQcDate': '2013-06-17', 'lastUpdatePostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "The study's outcome measures were recorded every evening between 17.00 and 21.00 hours", 'timeFrame': 'Nausea'}, {'measure': 'Pain', 'timeFrame': "The study's outcome measures were recorded every evening between 17.00 and 21.00 hours"}], 'primaryOutcomes': [{'measure': 'Defecation within 72 hours postoperatively', 'timeFrame': "The study's outcome measures were recorded every evening between 17.00 and 21.00 hours"}], 'secondaryOutcomes': [{'measure': 'Postoperative constipation', 'timeFrame': "The study's outcome measures were recorded every evening between 17.00 and 21.00 hours"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Spinal surgery', 'Bowel preparation', 'Ileus', 'Constipation', 'Well-being'], 'conditions': ['Constipation', 'Ileus', 'Surgery']}, 'descriptionModule': {'briefSummary': 'This study investigated the effect of preoperative bowel preparations for patients undergoing spinal fusion surgery.', 'detailedDescription': 'This was a randomised clinical trial with one control group and two treatment groups.\n\nForty-five elective spinal fusion patients were randomised into three groups who received preoperative treatment with either enema of sorbitol and docusat natrium, Bisacodyl suppository or no bowel preparation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing spinal fusion surgery\n* Age 15 years or older\n* The patients had to understand oral and written Norwegian.\n* Postoperative pain management via epidural catheter should have been planned.\n* Exclusion Criteria:\n* Constipation\n* Regularly use of enema'}, 'identificationModule': {'nctId': 'NCT01879605', 'briefTitle': 'Study About Effect of Preoperative Bowel Preparation Versus no Bowel Preparation Before Spinal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Preoperative Bowel Preparation Versus no Preparation Before Spinal Surgery: a Randomised Clinical Trial', 'orgStudyIdInfo': {'id': 'v57e4nbn'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enema', 'description': 'Docusate natrium and sorbitol, 240 ml enema, the evening before surgery', 'interventionNames': ['Drug: Docusate natrium and sorbitol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Suppository', 'description': 'Bisacodyl, suppository 10 mg, the evening before surgery.', 'interventionNames': ['Drug: Bisacodyl']}, {'type': 'NO_INTERVENTION', 'label': 'Control grup', 'description': 'No intervention'}], 'interventions': [{'name': 'Docusate natrium and sorbitol', 'type': 'DRUG', 'otherNames': ['Klyx'], 'armGroupLabels': ['Enema']}, {'name': 'Bisacodyl', 'type': 'DRUG', 'otherNames': ['Dulcolax'], 'armGroupLabels': ['Suppository']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'state': 'Oslo County', 'country': 'Norway', 'facility': 'Oslo Universitetssykehus', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Ida T Bjork, MNSc, PhD,', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oslo, Institute of Health and society'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}