Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:28 AM
Study NCT ID:
NCT07429760
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-02-24
First Post:
2026-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanical Bowel Preparation With or Without Oral Antibiotics in Left Sided Colorectal Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'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'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012293', 'term': 'Rifampin'}, {'id': 'D008795', 'term': 'Metronidazole'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This study is double blinded.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-01-08', 'studyFirstSubmitQcDate': '2026-02-17', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Site Infection (SSI)', 'timeFrame': '30 days', 'description': 'Any SSI and the type of SSI (superficial, deep incisional, and organ space) within 30 days of the index procedure based on the Centers for Disease Control and Prevention and National Nosocomial Infection Society criteria'}], 'secondaryOutcomes': [{'measure': 'anastomotic leak', 'timeFrame': '30 days', 'description': 'Anastomotic leak: defined as postoperative fluid collection adjacent to the anastomotic site seen on imaging scans and may require a percutaneous drainage procedure and/or an operative intervention.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal Cancer', 'Oral Antibiotics', 'Mechanical bowel preparation'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'In this study, Investigator will compare mechanical bowel preparation with or without oral antibiotics in Left sided colorectal cancer patients undergoing elective surgery.', 'detailedDescription': 'Surgical site infection (SSI) after colorectal surgery is a common postoperative complication, with rates of 15% to 20%, and significantly affects patient morbidity and mortality.\n\nGiven the high frequency of SSIs following colorectal procedures and the limited effectiveness of other preventive strategies, the combination of oral antibiotics with mechanical bowel preparation (MBP)-a technique initially evaluated in the 1970s but later discontinued-has regained attention as a potentially effective preventive approach. Recent studies have evaluated the combination of oral antibiotics and mechanical bowel preparation (MBP) with perioperative intravenous antibiotics, showing a significant reduction in the rate of surgical site infections (SSIs).\n\nThe Enhanced Recovery After Surgery (ERAS) Society indicates that randomized controlled trials provide some evidence supporting the use of both mechanical bowel preparation and oral antibiotics together, rather than using mechanical bowel preparation alone. American Society of Colon and Rectal Surgeons (ASCRS) Clinical Practice Guidelines also advise the combined use of mechanical bowel preparation and oral antibiotics for patients undergoing elective colorectal surgery. Mechanical bowel preparation before right sided colonic surgery offers no clinical benefit and may lead to preoperative dehydration, electrolyte imbalances, and patient discomfort. However, MBP is beneficial in left sided colorectal rectal surgery.\n\nDespite growing evidence supporting the use of oral antibiotics combined with mechanical bowel preparation (MBP), significant variability in clinical practice persists. In current practice, oral antibiotics are not routinely prescribed for colorectal cancer patients, so this will be interesting to evaluate the effect of oral antibiotics in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients\n\n * Diagnosed cases of left sided (distal to splenic flexure) colorectal cancer undergoing elective curative sphincter preserving surgery.\n * No contraindication for preoperative administration of oral antibiotics and mechanical bowel preparation.\n\nExclusion Criteria:\n\nEmergency surgery\n\n* Palliative surgery\n* Unwilling to participate in a trial'}, 'identificationModule': {'nctId': 'NCT07429760', 'briefTitle': 'Mechanical Bowel Preparation With or Without Oral Antibiotics in Left Sided Colorectal Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Shaukat Khanum Memorial Cancer Hospital & Research Centre'}, 'officialTitle': 'Mechanical Bowel Preparation With or Without Oral Antibiotics in Left Sided Colorectal Cancer Surgery: A Randomized Trial (MEBOA Trial)', 'orgStudyIdInfo': {'id': 'IRB 25-28'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mechanical bowel preparation with oral antibiotics', 'description': 'Mechanical bowel preparation arm with oral antibiotics Orally administered preparation of polyethylene glycol 2 days before surgery+ three doses of rifaximin 400mg at 7am, 3pm and 11pm the day before surgery and a single dose of metronidazole 500mg 11pm the day before surgery.', 'interventionNames': ['Drug: Rifampicin (R)']}, {'type': 'NO_INTERVENTION', 'label': 'Mechanical bowel preparation without oral antibiotics', 'description': 'Mechanical bowel preparation alone Orally administered preparation of polyethylene glycol 2 days before surgery'}], 'interventions': [{'name': 'Rifampicin (R)', 'type': 'DRUG', 'otherNames': ['Metronidazole'], 'description': 'Orally administered preparation of polyethylene glycol 2 days before surgery+ three doses of rifaximin 400mg at 7am, 3pm and 11pm the day before surgery and a single dose of metronidazole 500mg 11pm the day before surgery.', 'armGroupLabels': ['Mechanical bowel preparation with oral antibiotics']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Shaukat Khanam Memorial Cancer Hospital & Research Centre Lahore', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaukat Khanum Memorial Cancer Hospital & Research Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}