Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-26 @ 1:13 AM
Study NCT ID:
NCT04586634
Status:
COMPLETED
Last Update Posted:
2024-07-22
First Post:
2020-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Randomized Clinical Trial on Transanal Irrigation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094123', 'term': 'Low Anterior Resection Syndrome'}], 'ancestors': [{'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-studies@coloplast.com', 'phone': '+4549111111', 'title': 'Director of Clinical Strategy', 'organization': 'Coloplast'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'Investigator Assessed at visits and phone calls', 'eventGroups': [{'id': 'EG000', 'title': 'Peristeen', 'description': 'Subjects to use newly developed Peristeen cone catherter device', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 5, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'Subjects continue with their standard of care treatment which is conservative bowel management.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Mild Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'LARS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peristeen', 'description': 'Subjects to use newly developed Peristeen cone catherter device'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Subjects continue with their standard of care treatment which is conservative bowel management.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '27.8'}, {'value': '32.2', 'groupId': 'OG001', 'lowerLimit': '27.3', 'upperLimit': '37.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Total score measured per subject at study completion after 12 weeks', 'description': 'Obtained from the LARS score questionnaire on a scale from 0-42 in total score. Subscores are summed to get the total score. With 0 indicating lowest score and 42 highest score. 0-20 indicate No LARS, 21-29 minor LARS, 30-42 Major LARS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing data from 1 standard of care patient'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Major LARS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peristeen', 'description': 'Subjects to use newly developed Peristeen cone catherter device'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Subjects continue with their standard of care treatment which is conservative bowel management.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Obtained from the LARS score questionnaire on a scale from 0-42 in total score. Subscores are summed to get the total score. With 0 indicating lowest score and 42 highest score. 0-20 indicate No LARS, 21-29 minor LARS, 30-42 Major LARS.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'missing data from 1 participant in standard of care'}, {'type': 'SECONDARY', 'title': 'FIQL Score - Scale 1 Lifestyle, Modified American Society for Colorectal Surgeons Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peristeen', 'description': 'Subjects to use newly developed Peristeen cone catherter device'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Subjects continue with their standard of care treatment which is conservative bowel management.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.10', 'groupId': 'OG000', 'lowerLimit': '2.65', 'upperLimit': '3.55'}, {'value': '2.60', 'groupId': 'OG001', 'lowerLimit': '2.06', 'upperLimit': '3.15'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': "The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions).\n\nItems were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale).", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'FIQL Score - Scale 2 Coping/Behavior, Modified American Society for Colorectal Surgeons Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peristeen', 'description': 'Subjects to use newly developed Peristeen cone catherter device'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Subjects continue with their standard of care treatment which is conservative bowel management.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.95', 'groupId': 'OG000', 'lowerLimit': '2.55', 'upperLimit': '3.35'}, {'value': '2.37', 'groupId': 'OG001', 'lowerLimit': '1.91', 'upperLimit': '2.82'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': "The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions).\n\nItems were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale).", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'FIQL Score - Scale 3 Depression/Self-perception, Modified American Society for Colorectal Surgeons Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peristeen', 'description': 'Subjects to use newly developed Peristeen cone catherter device'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Subjects continue with their standard of care treatment which is conservative bowel management.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.41', 'groupId': 'OG000', 'lowerLimit': '2.87', 'upperLimit': '3.95'}, {'value': '3.23', 'groupId': 'OG001', 'lowerLimit': '2.76', 'upperLimit': '3.71'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': "The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions).\n\nItems were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale).", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'FIQL Score - Scale 4 Embarrassment , Modified American Society For Colorectal Surgeons Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peristeen', 'description': 'Subjects to use newly developed Peristeen cone catherter device'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Subjects continue with their standard of care treatment which is conservative bowel management.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.98', 'groupId': 'OG000', 'lowerLimit': '2.57', 'upperLimit': '3.38'}, {'value': '2.76', 'groupId': 'OG001', 'lowerLimit': '2.26', 'upperLimit': '3.27'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': "The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions).\n\nItems were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale).", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'EQ-5D-5L - Utility Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peristeen', 'description': 'Subjects to use newly developed Peristeen cone catherter device'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Subjects continue with their standard of care treatment which is conservative bowel management.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000', 'lowerLimit': '0.86', 'upperLimit': '0.97'}, {'value': '0.88', 'groupId': 'OG001', 'lowerLimit': '0.81', 'upperLimit': '0.95'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': "Each of the five dimensions comprising the EQ-5D descriptive system (mobility, self-care, usual activates, pain/discomfort, anxiety/depression) was divided into five levels:\n\n1. no problem\n2. slight problems\n3. moderate problems\n4. severe problems\n5. unable to/extreme problems A unique health state was defined by combining one level from each of the five dimensions. i.e. state 12345 each state referred to by a 5-digit code was mapped into a utility score.\n\nValues are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. EQ-5D-5L health states are converted into a single index 'utility' score using a scoring algorithm based on public preferences. Potential values from this algorithm can range from minus scores up to 1, in this case -0.525 to 1.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'EQ-5D-5L - VAS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peristeen', 'description': 'Subjects to use newly developed Peristeen cone catherter device'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Subjects continue with their standard of care treatment which is conservative bowel management.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.8', 'groupId': 'OG000', 'lowerLimit': '70.2', 'upperLimit': '95.5'}, {'value': '71.4', 'groupId': 'OG001', 'lowerLimit': '57.8', 'upperLimit': '85.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': "The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The VAS scale is from 0 to 100 with 0 indicating worst health and 100 best health possible.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Satisfaction With Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peristeen', 'description': 'Subjects to use newly developed Peristeen cone catherter device'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Subjects continue with their standard of care treatment which is conservative bowel management.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '9.7'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '8.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Satisfaction with current bowel management treatment on a scale from 0 (total dissatisfaction) to 10 (perfect satisfaction)" rated on a VAS scale from 0 to 10 cm.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Peristeen', 'description': 'Subjects to use newly developed Peristeen cone catherter device\n\nPeristeen cone catheter: The active intervention is the Peristeen cone catheter device.\n\nThe comparator in this investigation is current standard of care for patients with LARS which is conservative bowel management.'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'subjects continue with their standard of care treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Peristeen', 'description': 'Subjects to use newly developed Peristeen cone catherter device'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'Subjects continue with their standard of care treatment which is conservative bowel management.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.3', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '62.9', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '63.1', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Completed participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-21', 'size': 1197808, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-06T03:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2020-09-30', 'resultsFirstSubmitDate': '2023-05-03', 'studyFirstSubmitQcDate': '2020-10-07', 'lastUpdatePostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-06', 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LARS Score', 'timeFrame': 'Total score measured per subject at study completion after 12 weeks', 'description': 'Obtained from the LARS score questionnaire on a scale from 0-42 in total score. Subscores are summed to get the total score. With 0 indicating lowest score and 42 highest score. 0-20 indicate No LARS, 21-29 minor LARS, 30-42 Major LARS.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Major LARS', 'timeFrame': '12 weeks', 'description': 'Obtained from the LARS score questionnaire on a scale from 0-42 in total score. Subscores are summed to get the total score. With 0 indicating lowest score and 42 highest score. 0-20 indicate No LARS, 21-29 minor LARS, 30-42 Major LARS.'}, {'measure': 'FIQL Score - Scale 1 Lifestyle, Modified American Society for Colorectal Surgeons Questionnaire', 'timeFrame': '12 weeks', 'description': "The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions).\n\nItems were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale)."}, {'measure': 'FIQL Score - Scale 2 Coping/Behavior, Modified American Society for Colorectal Surgeons Questionnaire', 'timeFrame': '12 weeks', 'description': "The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions).\n\nItems were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale)."}, {'measure': 'FIQL Score - Scale 3 Depression/Self-perception, Modified American Society for Colorectal Surgeons Questionnaire', 'timeFrame': '12 weeks', 'description': "The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions).\n\nItems were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale)."}, {'measure': 'FIQL Score - Scale 4 Embarrassment , Modified American Society For Colorectal Surgeons Questionnaire', 'timeFrame': '12 weeks', 'description': "The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions).\n\nItems were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale)."}, {'measure': 'EQ-5D-5L - Utility Score', 'timeFrame': '12 weeks', 'description': "Each of the five dimensions comprising the EQ-5D descriptive system (mobility, self-care, usual activates, pain/discomfort, anxiety/depression) was divided into five levels:\n\n1. no problem\n2. slight problems\n3. moderate problems\n4. severe problems\n5. unable to/extreme problems A unique health state was defined by combining one level from each of the five dimensions. i.e. state 12345 each state referred to by a 5-digit code was mapped into a utility score.\n\nValues are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. EQ-5D-5L health states are converted into a single index 'utility' score using a scoring algorithm based on public preferences. Potential values from this algorithm can range from minus scores up to 1, in this case -0.525 to 1."}, {'measure': 'EQ-5D-5L - VAS Score', 'timeFrame': '12 weeks', 'description': "The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The VAS scale is from 0 to 100 with 0 indicating worst health and 100 best health possible."}, {'measure': 'Satisfaction With Treatment', 'timeFrame': '12 weeks', 'description': 'Satisfaction with current bowel management treatment on a scale from 0 (total dissatisfaction) to 10 (perfect satisfaction)" rated on a VAS scale from 0 to 10 cm.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Anterior Resection Syndrome']}, 'descriptionModule': {'briefSummary': 'Objective The primary objective is to demonstrate superiority of the Peristeen cone catheter compared to standard of care.\n\nThe secondary objective is to investigate quality of life and different benefits and aspects of treatment and satisfaction with the Peristeen cone catheter.\n\nDesign of the investigation This is a randomised, open-label, parallel investigation comparing the Peristeen cone catheter with standard of care in subjects with major LARS (LARS score ≥ 30). Each subject will be enrolled for a study duration of 12 weeks. Subjects will be randomized to the treatments stratified by neo-adjuvant radiotherapy.\n\nThe comparator in this study will be current standard of care for patients with LARS which is conservative bowel management. This is defined as: Supportive therapy according to the individual treatment protocols available at each participating site.\n\nPrimary endpoint and secondary endpoints\n\nPrimary endpoint:\n\n• LARS score, obtained from the LARS score questionnaire\\*\n\nSecondary endpoints:\n\n* Number of subjects with Major LARS\\*\n* FIQL Score - scale 1, Modified American Society for Colorectal Surgeons Questionnaire\\*\n* FIQL Score - scale 2, Modified American Society for Colorectal Surgeons Questionnaire\\*\n* FIQL Score - scale 3, Modified American Society for Colorectal Surgeons Questionnaire\\*\n* FIQL Score - scale 4, Modified American Society for Colorectal Surgeons Questionnaire\\*\n* EQ-5D-5L - utility score\\*\n* EQ-5D-5L - VAS score (scale 0-10 cm)\\*\n* Satisfaction with treatment (scale 0-10 cm)\\*\n* Number of adverse events\\* \\*All endpoints are measured per subject at study completion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be at least 18 years of age and have full legal Capacity\n2. Have given written informed consent\n3. Be mental and physical capable to perform transanal irrigation with cone catheter\n4. Have a LARS score ≥ 30 after rectal resection\n5. Be treated according to individual treatment protocol for conservatory bowel management at participating site\n6. Have proof of complete healing of the anastomosis by endoscopy or radiology before stoma closure\n7. At least 3-months from last surgery in colorectum\n8. Be evaluated to be suitable for transanal Irrigation procedure with a cone catheter by endoscopy, defecography or comparable procedure\n\nExclusion Criteria:\n\n1. Active/recurrent colorectal cancer\n2. Leaking anastomosis\n3. Known anal or colorectal stenosis\n4. Within 4 weeks of endoscopic polypectomy\n5. Ischaemic colitis\n6. Acute inflammatory bowel disease\n7. Acute diverticulitis\n8. Current or planned pregnancy'}, 'identificationModule': {'nctId': 'NCT04586634', 'briefTitle': 'Randomized Clinical Trial on Transanal Irrigation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'Randomized Clinical Trial Assessing the Effect of Transanal Irrigation With Cone Catheter Versus Conservative Bowel Management on Symptoms of Low Anterior Resection Syndrome After Rectal Resection', 'orgStudyIdInfo': {'id': 'CP327'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Peristeen', 'description': 'Subjects to use newly developed Peristeen cone catherter device', 'interventionNames': ['Device: Peristeen cone catheter']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'subjects continue with their standard of care treatment'}], 'interventions': [{'name': 'Peristeen cone catheter', 'type': 'DEVICE', 'description': 'The active intervention is the Peristeen cone catheter device. The comparator in this investigation is current standard of care for patients with LARS which is conservative bowel management.', 'armGroupLabels': ['Peristeen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Humlebæk', 'country': 'Denmark', 'facility': 'Coloplast A/S', 'geoPoint': {'lat': 55.9618, 'lon': 12.5341}}], 'overallOfficials': [{'name': 'Guillaume Meurette, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Nantes, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'MedPass International', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}