Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-01-01 @ 7:57 AM
Study NCT ID:
NCT04740957
Status:
UNKNOWN
Last Update Posted:
2023-09-18
First Post:
2021-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterising the Natural History of Mucosal Metabolism During Colorectal Anastomotic Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-14', 'studyFirstSubmitDate': '2021-02-03', 'studyFirstSubmitQcDate': '2021-02-03', 'lastUpdatePostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in microbial diversity', 'timeFrame': '1 year', 'description': 'Changes in microbial abundance and diversity at the anastomosis. The nature of any change is as yet not investigated and unpredictable - this is an observational outcome measure.'}], 'primaryOutcomes': [{'measure': 'Anastomotic healing', 'timeFrame': '1 year', 'description': 'Healing of the colorectal anastomosis when assessed endoscopically - with no visible defects in the anastomosis.'}], 'secondaryOutcomes': [{'measure': 'Failure of anastomotic healing', 'timeFrame': '1 year', 'description': 'Anastomotic leak detected either by radiological imaging (CT scanning) or a direct return to theatre'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healing of Colorectal Anastomoses']}, 'descriptionModule': {'briefSummary': 'This pilot study aims to investigate anastomotic healing and its underlying mechanisms at a mucosal level. It is a first-in-human study which will demonstrate the safety of post-operative endoscopic assessment of a colorectal anastomosis and provide preliminary data in order to power future interventional studies.\n\n100 patients undergoing elective left colonic or rectal resection with a primary anastomosis will be recruited pre-operatively throughout the study period. This study will not affect or delay the intended treatment for study participants.\n\nPatients will undergo serial endoscopic examination of the anastomosis post-operatively. Blood, urine, stool, and mucosal biopsies will be serially collected.\n\nA subgroup of 20 patients with a defunctioning ileostomy will be recruited to an interventional arm. This interventional arm will demonstrate the safety of re-introducing ileostomy effluent into the downstream (distal) limb of an ileostomy. The preliminary data will enable exploration of the association between microbiome and post-operative function and enable adequate powering of future interventional studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients undergoing elective left sided colonic or rectal resections with primary anastomosis with or without diverting ileostomy.\n\nExclusion Criteria:\n\n* Inability to communicate in English\n* People who lack capacity to consent\n* Emergency colorectal resection whilst awaiting elective surgery\n* Age \\<18\n* Permanent stoma formation\n* People on long term immunosuppressive medication\n* People on long term renal replacement therapy.'}, 'identificationModule': {'nctId': 'NCT04740957', 'briefTitle': 'Characterising the Natural History of Mucosal Metabolism During Colorectal Anastomotic Healing', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Characterising the Natural History of Mucosal Metabolism During Colorectal Anastomotic Healing', 'orgStudyIdInfo': {'id': 'IRAS 246354'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Observational cohort', 'description': '100 patients undergoing elective left colonic or rectal resection with a primary anastomosis will be recruited pre-operatively throughout the study period. This study will not affect or delay the intended treatment for study participants.\n\nPatients will undergo serial endoscopic examination of the anastomosis post-operatively. Blood, urine, stool, and mucosal biopsies will be serially collected.'}, {'type': 'EXPERIMENTAL', 'label': 'Distal limb feeding cohort', 'description': 'This interventional arm will demonstrate the safety of re-introducing ileostomy effluent into the downstream (distal) limb of an ileostomy. The preliminary data will enable exploration of the association between microbiome and post-operative function and enable adequate powering of future interventional studies.\n\nA subgroup of 20 patients undergoing a resection with a covering ileostomy will be recruited to the intervention arm. Complete healing of the colorectal anastomosis will first be confirmed by water-soluble contrast enema 8 weeks post-operatively (this is standard practice). Patients will be taught how to inject the output from the proximal ileostomy limb into the distal limb (this connects to the colon and thus the colorectal anastomosis) daily until the ileostomy closure date.', 'interventionNames': ['Other: Distal limb reintroduction of ileostomy effluent']}], 'interventions': [{'name': 'Distal limb reintroduction of ileostomy effluent', 'type': 'OTHER', 'description': 'Patients will undergo water soluble contrast enema to confirm anastomotic healing 8 weeks post operatively as per standard practice at Imperial.\n\nPatients will be educated in how to reintroduce ileostomy output to the distal (downstream) loop of their ileostomy. They will be asked to reintroduce 50ml of ileostomy output using a conventional long-tipped bladder syringe daily until surgery to close the stoma.', 'armGroupLabels': ['Distal limb feeding cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'James Kinross, PhD FRCS', 'role': 'CONTACT', 'email': 'j.kinross@imperial.ac.uk', 'phone': '020 3312 2124'}, {'name': 'James Lewis, MBBS', 'role': 'CONTACT', 'email': 'james.lewis1@imperial.ac.uk', 'phone': '020 3312 2124'}], 'facility': 'Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'James Kinross, PhD FRCS', 'role': 'CONTACT', 'email': 'j.kinross@imperial.ac.uk', 'phone': '020 3312 2124'}, {'name': 'James Lewis, MRCS', 'role': 'CONTACT', 'email': 'james.lewis1@imperial.ac.uk', 'phone': '020 3312 2124'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}