Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-29 @ 11:42 AM
Study NCT ID:
NCT04862793
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2021-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computerized Feedback in Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized controlled cluster trial following a stepped-wedge randomization.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-23', 'studyFirstSubmitDate': '2021-04-21', 'studyFirstSubmitQcDate': '2021-04-23', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feedback from CoRS results in change in Adenoma Detection Rate for individual operators and for the department as a whole.', 'timeFrame': 'Baseline (pre-intervention) and with the end of each time cluster (month 8, 12, 16, 18). The intervention will be at different time clusters for the three participating hospitals, and therefore the baseline sampling period will be different.', 'description': 'The Adenoma Detection Rate of an operator is correlated to patient survival of colorectal cancer. A low Adenoma Detection Rate is correlated with a higher occurrence of interval cancer. Increasing the Adenoma Detection Rate will result in a more beneficial screening program with more cancers being caught in an earlier state and thereby increase patient survival.'}, {'measure': 'Feedback from CoPS results in change in patient discomfort.', 'timeFrame': 'Baseline (pre-intervention) and with the end of each time cluster (month 8, 12, 16, 18). The intervention will be at different time clusters for the three participating hospitals, and therefore the baseline sampling period will be different.', 'description': 'Patient discomfort will be assessed by a post-procedure questionnaire. We will examine the correlation between the intervention and patient discomfort, and assess if more procedures can be completed due to less patient discomfort using the intervention.'}], 'secondaryOutcomes': [{'measure': 'Make an immediate measure to assess the quality of individual colonoscopy performance.', 'timeFrame': 'On data collection completion, estimated December 2023', 'description': 'To measure a reliable Adenoma detection rate, 500 procedures are needed. We will aim to make an immediate measure based on CoRS to assess the quality of each colonoscopy and investigate this measures correlation to the ADR in the intervention period.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colonoscopy', 'Adenoma Detection Rate', 'Computerized Feedback'], 'conditions': ['Colorectal Cancer', 'Healthy']}, 'descriptionModule': {'briefSummary': 'In a cluster-randomized study compare if feedback from two computerized feedback systems doing a colonoscopy (CoPS and CoRS) can improve the adenoma detection rate and decrease patient discomfort.', 'detailedDescription': 'Background:\n\nApproximately 4,600 persons get colon cancer annually in Denmark and it is the second most common cause of cancer death. Survival is highly dependent on early detection through a colonoscopy. A thorough colonoscopy is essential to detect early cancers but unfortunately the quality of colonoscopies varies widely between operators. A study of 314,872 colonoscopies performed by 136 gastroenterologists found that the adenoma detection rate (ADR) ranged from 7 - 53% and was inversely associated with the risks of fatal interval cancer. The investigators have developed to tools that can generate automatic, computerized feedback in order to make a more thorough procedure and reduce patient discomfort, the Colonoscopy Progression Score (CoPS) and Colonoscopy Retraction Score (CoRS)\n\nObjectives:\n\nThe investigators predict that live-feedback from CoPS and CoRS doing a colonoscopy can improve the ADR and subsequent prevent colorectal cancer. The aim of this project is to:\n\n1. In a cluster-randomized study compare if feedback from CoPS and CoRS can improve the adenoma detection rate and patient satisfaction for individual operators and the department as a whole.\n2. Make an immediate measure to assess the quality of individual colonoscopy performance.\n\nMaterials and methodology:\n\nAs a randomized controlled cluster trial following a stepped-wedge program, feedback doing a colonoscopy from these (CoPS and CoRS) will be tested compared to no feedback. Three test departments consisting of three University Hospital in the Capital region of Denmark will be included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted for a screening colonoscopy through the Danish National Screening Program for Colorectal Cancer.\n\nExclusion Criteria: Incomplete procedure due to:\n\n* In cases were the cecum is not reached.\n* Unsatisfactory bowel preparation which results in admission for a new procedure'}, 'identificationModule': {'nctId': 'NCT04862793', 'briefTitle': 'Computerized Feedback in Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen Academy for Medical Education and Simulation'}, 'officialTitle': 'Impact of Computerized Feedback During Colonoscopy on Adenoma Detection Rate of Colorectal Cancer and Patient Related Satisfaction: A Cluster-randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'P-2021-256'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Feedback', 'description': 'Feedback system through CoPS and CoRS', 'interventionNames': ['Device: Colonoscopy Progression Score (CoPS)', 'Device: Colonoscopy Retraction Score (CoRS)']}, {'type': 'NO_INTERVENTION', 'label': 'Standard procedure', 'description': 'Performing the standard procedure in accordance with the departments usual conduct.'}], 'interventions': [{'name': 'Colonoscopy Progression Score (CoPS)', 'type': 'DEVICE', 'description': 'The Colonoscopy Progression Score consists of five different aspects: Travel length, Tip progression, chase efficiency, shaft movement without tip progression and looping.', 'armGroupLabels': ['Feedback']}, {'name': 'Colonoscopy Retraction Score (CoRS)', 'type': 'DEVICE', 'description': 'The Colonoscopy Retraction Score consists of three different aspects: Tip Retraction, Retraction Efficiency, and Retraction Distance.', 'armGroupLabels': ['Feedback']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kristoffer Mazanti Cold, MD', 'role': 'CONTACT', 'email': 'kristoffer.mazanti.cold@regionh.dk', 'phone': '+4541442103'}, {'name': 'Lars Konge, MD, PhD', 'role': 'CONTACT', 'email': 'lars.konge@regionh.dk', 'phone': '+4530230210'}], 'overallOfficials': [{'name': 'Kristoffer Mazanti Cold, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PhD-alumni'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'At end of data collection (December 2023) and for the following 5 years.', 'ipdSharing': 'YES', 'description': 'all IPD that underlie results in a publication', 'accessCriteria': 'On request to the primary investigator with a useful scientific purpose.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen Academy for Medical Education and Simulation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Cancer Society', 'class': 'OTHER'}, {'name': 'Ambu A/S', 'class': 'INDUSTRY'}, {'name': 'Region Capital Denmark', 'class': 'OTHER'}, {'name': 'Herlev Hospital', 'class': 'OTHER'}, {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, {'name': 'Hillerod Hospital, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kristoffer Mazanti Cold', 'investigatorAffiliation': 'Copenhagen Academy for Medical Education and Simulation'}}}}