Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT04730102
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2021-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rectal Washout in Transanal Total Mesorectal Excision and Presence of Intraluminal Malignant Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal 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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-09', 'studyFirstSubmitDate': '2021-01-25', 'studyFirstSubmitQcDate': '2021-01-25', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Existence of intraluminal malignant cells in fluid samples from rectal washout', 'timeFrame': 'Intraoperatively', 'description': 'Positive/negative cytology'}], 'secondaryOutcomes': [{'measure': 'Fluid volume needed to perform rectal washout during transanal total mesorectal excision to eliminate intraluminal malignant cells', 'timeFrame': 'Intraoperatively', 'description': 'Positive/negative cytology'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rectal washout', 'transanal total mesorectal excision', 'rectal cancer'], 'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'The study aims to assess the existence of intraluminal malignant cells and the appropriate fluid volume needed to perform rectal washout during transanal total mesorectal excision (taTME) for rectal cancer.', 'detailedDescription': 'Twenty patients undergoing taTME for rectal cancer is included. Following the closure of the rectal lumen by a purse string suture, rectal washout is performed with a total of 500 ml sterile water. Fluid samples are collected after every 100 ml by instilling 50 ml of saline after each washout. A sixth sample is collected from the presacral cavity. Each sample is cytologically examined by a pathologist and labelled either malignant or non-malignant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing transanal mesorectal excision at Slagelse Hospital, Denmark', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgery at Slagelse Hospital for rectal cancer with transanal mesorectal excision\n* Consent to participate in the study\n\nExclusion Criteria:\n\n* No consent to participate\n* No surgery'}, 'identificationModule': {'nctId': 'NCT04730102', 'briefTitle': 'Rectal Washout in Transanal Total Mesorectal Excision and Presence of Intraluminal Malignant Cells', 'organization': {'class': 'OTHER', 'fullName': 'Slagelse Hospital'}, 'officialTitle': 'Rectal Washout in Transanal Total Mesorectal Excision and Presence of Intraluminal Malignant Cells', 'orgStudyIdInfo': {'id': 'SJ-817'}, 'secondaryIdInfos': [{'id': '2019-2567', 'type': 'OTHER_GRANT', 'domain': 'Stig & Ragna Gorthons Foundation'}, {'id': 'ALF Region Skåne', 'type': 'OTHER_GRANT', 'domain': 'Governmental funding of clinical research within the National Health Services'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing rectal washout in transanal mesorectal excision', 'description': 'Patients undergoing rectal washout in transanal mesorectal excision for rectal cancer.', 'interventionNames': ['Procedure: Rectal washout']}], 'interventions': [{'name': 'Rectal washout', 'type': 'PROCEDURE', 'description': 'Rectal washout is performed intraoperatively before transection and means irrigation of the rectum following the closure of the rectal lumen below the tumour with a purse string suture. Rectal washout is performed with a total of 500 ml sterile water. Fluid samples are collected after every 100 ml by instilling 50 ml of saline after each washout. A sixth sample is collected from the presacral cavity.', 'armGroupLabels': ['Patients undergoing rectal washout in transanal mesorectal excision']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4200', 'city': 'Slagelse', 'state': 'Region Sjælland', 'country': 'Denmark', 'facility': 'Slagelse Hospital', 'geoPoint': {'lat': 55.40276, 'lon': 11.35459}}], 'overallOfficials': [{'name': 'Pamela Buchwald', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Skåne University Hospital, Malmö, Region Skåne, Sweden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Slagelse Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Skane University Hospital', 'class': 'OTHER'}, {'name': 'Lund University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}