Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-01-08 @ 7:23 AM
Study NCT ID:
NCT05546892
Status:
UNKNOWN
Last Update Posted:
2023-03-29
First Post:
2022-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Cancer Resections Versus no Bowel Preparation
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 586}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2022-09-15', 'studyFirstSubmitQcDate': '2022-09-15', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anastomotic leak rate', 'timeFrame': '30 days', 'description': 'Rate of anastomotic leak in patients after colon resections'}], 'secondaryOutcomes': [{'measure': 'Surgical site infection (SSI) rate', 'timeFrame': '30 days', 'description': 'Rate of Surgical site infection'}, {'measure': 'Intraabdominal and or pelvic abscess rate', 'timeFrame': '30 days', 'description': 'Rate of intraabdominal and or pelvic abscess'}, {'measure': 'Overall morbidity', 'timeFrame': '30 days', 'description': 'Rate of patients with any complications after surgery'}, {'measure': 'Rate of intraoperative complications', 'timeFrame': 'Duration of surgical procedure', 'description': 'Rate of patients with intraoperative complications'}, {'measure': 'Surgery duration in minutes', 'timeFrame': 'Duration of surgical procedure', 'description': 'Time of surgical procedure'}, {'measure': 'Quality of bowel preparation assessed by surgeon', 'timeFrame': 'Day of surgical procedure', 'description': 'Assessment of bowel preparation quality by surgeon (qualitative scale)'}, {'measure': 'Bowel preparation compliance', 'timeFrame': 'Day of surgical procedure', 'description': 'Rate of patients in experimental arm undergoing complete bowel preparation according to protocol'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colon cancer', 'MBP', 'bowel preparation', 'oral antibiotics'], 'conditions': ['Colon Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if short-term outcomes of colon resections after full bowel preparation (mechanical bowel preparation plus oral antibiotics) are superior to colon resections with no bowel preparation.', 'detailedDescription': 'The design involves random allocation of eligible patients to full bowel preparation or no bowel preparation in 1:1 ratio. After that colon resection is performed in both groups.\n\nShort-term outcomes are assessed in 30 day period after surgery. This is a superiority trial evaluating statistical superiority. Rate of anastomotic leak is anticipated to decrease from 8% (data from local registry) to 3%. For power of 80% enrolment of 586 patients is required.\n\nThe intent-to-treat principle is used for the data analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* histologically confirmed adenocarcinoma of the colon (caecum, ascending, transverse, descending, sigmoid)\n* clinical stage T1-4aN0-2M0-1 (distant metastases must be resectable)\n* indications for surgical colonic resection\n* ECOG status 0-2\n* At least 18 years of age\n* Written informed consent\n\nExclusion Criteria:\n\n* Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol\n* Pregnancy or breast feeding\n* Medical contraindications for surgical treatment\n* Any use of antibiotics 30 days prior to inclusion\n* Functioning stoma\n* Contraindications for use of MBP or OA drugs or their components\n* Indications for mandatory MBP (planned intraoperative colonoscopy etc)\n* Indications for obstructive resection\n* Acute bowel obstruction, bleeding or perforation\n* Other malignancies not in remission"}, 'identificationModule': {'nctId': 'NCT05546892', 'acronym': 'COLRABI', 'briefTitle': 'Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Cancer Resections Versus no Bowel Preparation', 'organization': {'class': 'OTHER', 'fullName': 'N.N. Petrov National Medical Research Center of Oncology'}, 'officialTitle': 'Short-term Outcomes of Full Bowel Preparation (MBP+OA) for Colon Resections for Cancer Versus no Bowel Preparation', 'orgStudyIdInfo': {'id': 'COL-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Full bowel preparation (MBP+OA)', 'description': 'Rifaximin 400 mg twice daily for three days prior to surgery\n\nDay prior to surgery:\n\n17.00 - 18.00 Macrogol-3350 - 100 g Natrium sulfate - 7,5 g Natrium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Natrii ascorbate - 5,9 g Clear fluids - 1000 ml\n\n18.00 - 19.00 Clear fluids 500 ml\n\n19.00 - 20.00 Macrogol-3350 - 100 g Natrium sulfate - 7,5 g Natrium chloride - 2,691 g Potassium chloride - 1,015 g Ascorbic acid - 4,7 g Natrii ascorbate - 5,9 g Clear fluids - 1000 ml\n\n20.00 - 21.00 Clear fluids 500 ml', 'interventionNames': ['Procedure: Full bowel preparation prior to colon resection for cancer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No bowel preparation', 'description': 'No bowel preparation (enema of not more then 500 ml is allowed prior or during surgery)', 'interventionNames': ['Procedure: No bowel preparation']}], 'interventions': [{'name': 'Full bowel preparation prior to colon resection for cancer', 'type': 'PROCEDURE', 'description': 'Mechanical bowel preparation and oral antibiotics', 'armGroupLabels': ['Full bowel preparation (MBP+OA)']}, {'name': 'No bowel preparation', 'type': 'PROCEDURE', 'description': 'Omission of any bowel preparation', 'armGroupLabels': ['No bowel preparation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '197758', 'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Aleksei Petrov', 'role': 'CONTACT', 'email': 'alexpetrov@doctor.com', 'phone': '+79214117866'}, {'name': 'Aleksei Karachun', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Aleksei Petrov', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'N.N. Petrov National Medical Research Center of Oncology', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'centralContacts': [{'name': 'Aleksei Karachun', 'role': 'CONTACT', 'email': 'dr.a.karachun@gmail.com', 'phone': '+79219462123'}, {'name': 'Aleksei Petrov', 'role': 'CONTACT', 'email': 'alexpetrov@doctor.com', 'phone': '+79214117866'}], 'overallOfficials': [{'name': 'Aleksei Karachun', 'role': 'STUDY_CHAIR', 'affiliation': 'N.N. Petrov National Medical Research Center of Oncology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We are not planning to share individual participant data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'N.N. Petrov National Medical Research Center of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}