Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:31 AM
Study NCT ID:
NCT04252560
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2020-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Gut Microbiota in Anastomoses Insufficiency After Resection and Direct Anastomosis for Colorectal Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D010534', 'term': 'Peritoneal 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'}, {'id': 'D000008', 'term': 'Abdominal Neoplasms'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003082', 'term': 'Colectomy'}], 'ancestors': [{'id': 'D000099090', 'term': 'Surgical Procedures, Colorectal'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Fecal samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2020-01-31', 'studyFirstSubmitQcDate': '2020-01-31', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbiome', 'timeFrame': '30 days', 'description': 'Change in microbiome in case of insufficiency of the anastomosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer, Peritoneal Carcinomatosis, Anastomosis Insufficiency']}, 'descriptionModule': {'briefSummary': 'The role of gut microbiota in anastomosis insufficiency in patients operated for colorectal cancer and for peritoneal carcinomatosis is going to be investigated. This is a pilot study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who meet the inclusion criteria and have none of the exclusion criteria are going to be asked to participate in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria Colorectal group\n\n* adenocarcinom in colon or rektum\n* curative operation planed\n* direct anastomose plan\n* elective surgery\n\nInclusion Criteria HIPEC group :\n\n* All patients with appendix, colon or rectal cancer accepted for CRS+HIPEC\n\nExclusion Criteria:\n\n* Ongoing antibiotics treatment\n* antibiotics treatment in the last 6 months\n* acute surgery\n* palliative surgery\n* Ulcerös colitis or Crohns disease\n* Prior colectomy\n* Small intestine stoma before the operation\n* neoadjuvant treatment\n* Colon preparation'}, 'identificationModule': {'nctId': 'NCT04252560', 'briefTitle': 'The Impact of Gut Microbiota in Anastomoses Insufficiency After Resection and Direct Anastomosis for Colorectal Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University Hospital'}, 'officialTitle': 'The Impact of Gut Microbiota in Anastomoses Insufficiency After Resection and Direct Anastomosis for Colorectal Cancer.', 'orgStudyIdInfo': {'id': '2019-04562'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Colorectal', 'description': '30 patients operated for colorectal cancer', 'interventionNames': ['Procedure: Colectomy, CRS+HIPEC']}, {'label': 'HIPEC', 'description': '15 patients operated with CRS+HIPEC for peritoneal carcinomatosis', 'interventionNames': ['Procedure: Colectomy, CRS+HIPEC']}], 'interventions': [{'name': 'Colectomy, CRS+HIPEC', 'type': 'PROCEDURE', 'description': 'No special interventions are going to be performed. Fecal samples are going to be taken and analysed', 'armGroupLabels': ['Colorectal', 'HIPEC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not allowed by the Ethical Committee'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Konstantinos Tsimogiannis', 'investigatorAffiliation': 'Uppsala University Hospital'}}}}