Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT04281667
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-11-17
First Post:
2020-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D013530', 'term': 'Surgical Wound Infection'}], '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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 604}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2027-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-16', 'studyFirstSubmitDate': '2020-02-14', 'studyFirstSubmitQcDate': '2020-02-21', 'lastUpdatePostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '5-year overall survival', 'timeFrame': '5 years from surgery', 'description': '5-year overall survival'}, {'measure': '5-year disease specific survival', 'timeFrame': '5 years from surgery', 'description': '5-year disease specific survival'}, {'measure': '5-year recurrence free survival', 'timeFrame': '5 years from surgery', 'description': '5-year recurrence free survival'}, {'measure': 'Quality of life (SF-36)', 'timeFrame': 'At randomization and at one year from surgery', 'description': 'Difference in quality of life between baseline and 1 year measured using SF-36'}, {'measure': 'Quality of life (QLQ-C30)', 'timeFrame': 'At randomization and at one year from surgery', 'description': 'Difference in quality of life between baseline and 1 year measured using QLQ-C30'}, {'measure': 'Quality of life (QLQ-CR29)', 'timeFrame': 'At randomization and at one year from surgery', 'description': 'Difference in quality of life between baseline and 1 year measured using QLQ-CR29'}, {'measure': 'Quality of life (LARS)', 'timeFrame': 'At randomization and at one year from surgery', 'description': 'Difference in quality of life between baseline and 1 year measured using LARS'}, {'measure': 'Adverse effects of antibiotics', 'timeFrame': 'Within 30 days from surgery', 'description': 'Adverse effects of antibiotics'}, {'measure': 'Bowel microbiota', 'timeFrame': 'Before, at, 6 months, and 1 year after surgery.', 'description': 'Bowel microbiota'}], 'primaryOutcomes': [{'measure': 'Comprehensive Complication Index', 'timeFrame': 'Within 30 days from surgery', 'description': 'Comprehensive Complication Index score'}], 'secondaryOutcomes': [{'measure': 'Surgical Site Infection', 'timeFrame': 'Within 30 days from surgery', 'description': 'Surgical site infection as defined by CDC'}, {'measure': 'Anastomotic dehiscence', 'timeFrame': 'Within 30 days from surgery', 'description': 'Anastomotic dehiscence'}, {'measure': 'Lenght of hospital stay', 'timeFrame': 'Within hospital stay, estimated on average 7 days', 'description': 'Lenght of hospital stay'}, {'measure': 'Mortality', 'timeFrame': 'Within 90 days from surgery', 'description': 'Mortality'}, {'measure': 'Adjuvant therapy', 'timeFrame': 'Within 6 months from surgery', 'description': 'Patients receiving adjuvant therapy divided by patients needing adjuvant therapy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Adenocarcinoma', 'Rectum Neoplasm', 'Rectum Carcinoma', 'Colorectal Cancer', 'Colorectal Neoplasms', 'Colorectal Carcinoma', 'Surgical Site Infection', 'Surgery--Complications']}, 'referencesModule': {'references': [{'pmid': '38506889', 'type': 'DERIVED', 'citation': 'Koskenvuo L, Lunkka P, Varpe P, Hyoty M, Satokari R, Haapamaki C, Lepisto A, Sallinen V. Morbidity After Mechanical Bowel Preparation and Oral Antibiotics Prior to Rectal Resection: The MOBILE2 Randomized Clinical Trial. JAMA Surg. 2024 Jun 1;159(6):606-614. doi: 10.1001/jamasurg.2024.0184.'}, {'pmid': '36748942', 'type': 'DERIVED', 'citation': 'Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.'}, {'pmid': '34244284', 'type': 'DERIVED', 'citation': 'Koskenvuo L, Lunkka P, Varpe P, Hyoty M, Satokari R, Haapamaki C, Lepisto A, Sallinen V. Mechanical bowel preparation and oral antibiotics versus mechanical bowel preparation only prior rectal surgery (MOBILE2): a multicentre, double-blinded, randomised controlled trial-study protocol. BMJ Open. 2021 Jul 9;11(7):e051269. doi: 10.1136/bmjopen-2021-051269.'}, {'pmid': '32818460', 'type': 'DERIVED', 'citation': 'Koskenvuo L, Sallinen V. Preoperative oral antibiotics in colon surgery. Lancet Gastroenterol Hepatol. 2020 Sep;5(9):801-802. doi: 10.1016/S2468-1253(20)30203-X. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'MOBILE2 is a randomized controlled trial comparing mechanical and oral antibiotic bowel preparation to mechanical bowel preparation only in patients undergoing anterior rectal resection with primary anastomosis. Primary endpoint is Comprehensive Complication Index within 30 days from surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for anterior rectal resection with primary anastomosis\n\nExclusion Criteria:\n\n* Emergency operation\n* Bowel obstruction\n* Existing stoma\n* Other reason preventing mechanical bowel preparation\n* Allergy to neomycin or metronidazole\n* Age \\< 18 years\n* Lack of co-operation\n\nExclusion criteria after randomization:\n\n* Patient did not undergo surgery\n* Anterior resection was not performed\n* Colonic anastomosis was not performed'}, 'identificationModule': {'nctId': 'NCT04281667', 'acronym': 'MOBILE2', 'briefTitle': 'Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery - a Prospective, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '14112018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mechanical Bowel Preparation and Oral Antibiotics', 'description': 'Mechanical Bowel Preparation and Oral Antibiotics', 'interventionNames': ['Drug: Oral Antibiotics', 'Drug: Mechanical Bowel Preparation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mechanical Bowel Preparation Only', 'description': 'Mechanical Bowel Preparation Only', 'interventionNames': ['Drug: Placebo', 'Drug: Mechanical Bowel Preparation']}], 'interventions': [{'name': 'Oral Antibiotics', 'type': 'DRUG', 'description': 'Oral antibiotics (neomycin 1g and metronidazole 1g at 3pm and 11pm the day before surgery)', 'armGroupLabels': ['Mechanical Bowel Preparation and Oral Antibiotics']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral placebos (placebo 1 and placebo 2 at 3pm and 11pm the day before surgery)', 'armGroupLabels': ['Mechanical Bowel Preparation Only']}, {'name': 'Mechanical Bowel Preparation', 'type': 'DRUG', 'description': 'Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep)', 'armGroupLabels': ['Mechanical Bowel Preparation Only', 'Mechanical Bowel Preparation and Oral Antibiotics']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Laura Koskenvuo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}, {'name': 'Anna Lepistö, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Helsinki University Central Hospital'}, {'name': 'Ville Sallinen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Helsinki University Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual deidentified participant data will not be available for sharing. Study protocol will be available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adj. Prof.', 'investigatorFullName': 'Ville Sallinen', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}