Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-02-24 @ 10:06 AM
Study NCT ID:
NCT00427492
Status:
COMPLETED
Last Update Posted:
2009-02-11
First Post:
2007-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Postoperative Laxative on Bowel Function After Colonic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008277', 'term': 'Magnesium Oxide'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-10', 'studyFirstSubmitDate': '2007-01-26', 'studyFirstSubmitQcDate': '2007-01-26', 'lastUpdatePostDateStruct': {'date': '2009-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to defecation after colonic resection', 'timeFrame': '2-8 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Colonic Cancer']}, 'descriptionModule': {'briefSummary': 'Randomised doublet blinded study of the effect of tablet Magnesia (laxative) on post operative bowel ileus after open colonic resection. Material: 56 patients in two equal groups. Primary endpoint: Bowel function. Secondary endpoints: Intake of food and drinks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with planned elective colonic resection\n\nExclusion Criteria:\n\n* Previous extended abdominal surgery\n* Pregnancy\n* Opioid or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT00427492', 'briefTitle': 'Effect of Postoperative Laxative on Bowel Function After Colonic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Effect of Postoperative Laxative on Bowel Function After Colonic Surgery', 'orgStudyIdInfo': {'id': '02 290964'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Magnesia', 'description': 'Medical laxative', 'interventionNames': ['Drug: Magnesia', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Magnesia', 'type': 'DRUG', 'description': 'Tablet magnesia 500mg. 2 tablet 2 times a day for a week', 'armGroupLabels': ['Magnesia']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Magnesia', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Copenhagen University hospital Hvidovre', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'overallOfficials': [{'name': 'Jens Andersen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Copenhagen University Hospital, Hvidovre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jens Andersen. Consultant Surgeon', 'oldOrganization': 'Copenhagen University Hospital - Hvidovre'}}}}