Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-30 @ 12:28 AM
Study NCT ID:
NCT03257332
Status:
WITHDRAWN
Last Update Posted:
2020-12-04
First Post:
2017-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Surgery for Rectal Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D004688', 'term': 'Encopresis'}, {'id': 'D000094123', 'term': 'Low Anterior Resection Syndrome'}], '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'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-04', 'size': 369021, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-07-19T07:53', 'hasProtocol': True}, {'date': '2019-07-04', 'size': 99774, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-07-19T07:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Not possible to include participants', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-02', 'studyFirstSubmitDate': '2017-08-17', 'studyFirstSubmitQcDate': '2017-08-17', 'lastUpdatePostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Urinary incontinence', 'timeFrame': '3, 6, 12, 26, 52 and 104 weeks', 'description': 'International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)'}, {'measure': 'Urinary incontinence - Urinary symptoms', 'timeFrame': '3, 6, 12, 26, 52 and 104 weeks', 'description': 'International Consultation on Incontinence Questionnaire - Male/female Lower Urinary Tract Symptoms (ICIQ-MLUTS og ICIQ-FLUTS)'}, {'measure': 'Urinary incontinence - Sexual dysfunction', 'timeFrame': '3, 6, 12, 26, 52 and 104 weeks', 'description': 'International Consultation on Incontinence Questionnaire - Male/female Sexual Matters associated with Lower Urinary Tract Symptoms (ICIQ-MLUTSsex or ICIQ-FLUTSsex)'}, {'measure': 'Global health status/quality of life: EORTC QLQ-C30', 'timeFrame': '3, 6, 12, 26 and 52 weeks', 'description': "European Organisation for Research and Treatment of Cancer's generic core set on quality of life (EORTC QLQ-C30)"}, {'measure': "Other subscales than 'global health status/quality of life': EORTC QLQ-C30", 'timeFrame': '3, 6, 12, 26, 52 and 104 weeks', 'description': "European Organisation for Research and Treatment of Cancer's generic core set on quality of life (EORTC QLQ-C30)"}, {'measure': 'Quality of life - colorectal cancer: EORTC QLQ-CR29', 'timeFrame': '3, 6, 12, 26, 52 and 104 weeks', 'description': "European Organisation for Research and Treatment of Cancer's colorectal cancer module (EORTC QLQ-CR29)"}, {'measure': 'Quality of life - Fatigue: EORTC QLQ-FA12', 'timeFrame': '3, 6, 12, 26, 52 and 104 weeks', 'description': "European Organisation for Research and Treatment of Cancer's fatigue module (EORTC QLQ-FA12)"}, {'measure': 'Quality of life - INFO: EORTC QLQ-INFO25', 'timeFrame': '3, 6, 12, 26, 52 and 104 weeks', 'description': "European Organisation for Research and Treatment of Cancer's information about disease and treatment module (EORTC QLQ-INFO25)"}, {'measure': 'Anorectal muscle function - digital examination', 'timeFrame': '6, 26, 52 and 104 weeks', 'description': 'Maximal resting pressure Maximal squeeze pressure Endurance squeeze - max squeeze pressure or longest time Latency (rate of force development), number of rectal muscle contractions/squeezes in 15 sec test.'}, {'measure': 'Anorectal Manometry - pressure', 'timeFrame': '6, 26, 52 and 104 weeks', 'description': 'Maximal resting pressure Maximal squeeze pressure Maximal squeeze pressure duration'}, {'measure': 'Anorectal Manometry - capacity', 'timeFrame': '6, 26, 52 and 104 weeks', 'description': 'Volume capacity measurements:\n\nMaximal tolerated volume Conscious rectal sensitivity threshold Conscious rectal sensitivity Constant sensation'}, {'measure': 'Faecal incontinence', 'timeFrame': '3, 6, 12, 26, 52 and 104 weeks', 'description': 'Self-reported questionnaire - St. Marks Incontinence score (Vaizey score)'}, {'measure': 'Low anterior resection syndrome', 'timeFrame': '3, 6, 12, 26 and 52 weeks', 'description': 'Self-reported questionnaire - Low anterior resection symptom - score (LARS-score)'}, {'measure': 'Physical activity level', 'timeFrame': '3, 6, 12, 26, 52 and 104 weeks', 'description': 'physical activity section of the Danish National Health Profile'}, {'measure': 'Finding meaning in life', 'timeFrame': '3, 6, 12, 26, 52 and 104 weeks', 'description': 'Sources of Meaning and Meaning in Life Questionnaire (SoMe)'}, {'measure': 'Physical performance', 'timeFrame': '6, 26, 52 and 104 weeks', 'description': '6-Minute Walk test'}], 'primaryOutcomes': [{'measure': 'Global health status/quality of life: EORTC QLQ-C30', 'timeFrame': '104 weeks', 'description': "European Organisation for Research and Treatment of Cancer's generic core set on quality of life (EORTC QLQ-C30)"}], 'secondaryOutcomes': [{'measure': 'Low anterior resection syndrome', 'timeFrame': '104 weeks', 'description': 'Self-reported questionnaire - Low anterior resection symptom - score (LARS-score)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rectum cancer', 'Low Anterior Rectal Syndrome', 'Anorectal muscle function'], 'conditions': ['Rectum Cancer', 'Quality of Life', 'Faecal Incontinence', 'Low Anterior Resection Syndrome']}, 'referencesModule': {'references': [{'pmid': '23939851', 'type': 'BACKGROUND', 'citation': 'Emmertsen KJ, Laurberg S; Rectal Cancer Function Study Group. Impact of bowel dysfunction on quality of life after sphincter-preserving resection for rectal cancer. Br J Surg. 2013 Sep;100(10):1377-87. doi: 10.1002/bjs.9223.'}, {'pmid': '23871359', 'type': 'BACKGROUND', 'citation': 'Lai X, Wong FK, Ching SS. Review of bowel dysfunction of rectal cancer patients during the first five years after sphincter-preserving surgery: a population in need of nursing attention. Eur J Oncol Nurs. 2013 Oct;17(5):681-92. doi: 10.1016/j.ejon.2013.06.001. Epub 2013 Jul 17.'}, {'pmid': '27377924', 'type': 'BACKGROUND', 'citation': 'Ma B, Gao P, Song Y, Zhang C, Zhang C, Wang L, Liu H, Wang Z. Transanal total mesorectal excision (taTME) for rectal cancer: a systematic review and meta-analysis of oncological and perioperative outcomes compared with laparoscopic total mesorectal excision. BMC Cancer. 2016 Jul 4;16:380. doi: 10.1186/s12885-016-2428-5.'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nPatients treated for rectal cancer are in high risk of developing poor quality of life and faecal incontinence. Faecal incontinence has a negative impact on quality of life. However, there is limited knowledge on how to prevent it. Known exposures are ; age at surgery, gender, tumor height, pre-operative radiotherapy, surgical technique and temporary stoma. In order to evaluate the underlying mechanisms of faecal incontinence, it is central to evaluate the anorectal muscle function for sensory and motor impairment. Exposures representing different constructs in the biopsychosocial model are likewise likely to be associated with quality of life and faecal incontinence. These exposures include sexual dysfunction, urinary incontinence, fatique, physical inactivity and finding meaning in life. There are to our knowledge, no records on these relationships from prior to surgery to 2 years after. These biopsychosocial exposures are central to include when developing strategies that can prevent poor quality of life and faecal incontinence for patients treated for rectal cancer.\n\nPurpose:\n\nThe primary purpose of the EDFI-Cohort study is to determine how several variables (surgical technique, anorectal muscle function, faecal incontinence, urinary incontinence, sexual dysfunction, fatigue, physical activity and finding meaning in life) develop over time and predicts quality of life. Secondary how it predicts LARS-score in patients with rectal cancer from prior to surgery to 2 years after primary treatment.\n\nMethods:\n\nWe will include subjects diagnosed with rectal cancer and have received curative surgery (low anterior resection) with/without adjuvant (radiation/chemo) therapy. The cohort aim to recruit all eligible patients in a one year period. We estimate to recruit 70 patients.\n\nSelf-reported outcomes will be collected with a series of validated questionnaires that subjects will be asked to complete 6 times during the two year study at 3, 6, 12, 26 78 and 104 weeks. Outcomes include: Quality of life using (EORTC QLQ-C30) (primary outcome), (CR29) and (FA12), bowel related quality of life (LARS-score) (secondary outcome), faecal incontinence (Vaizey score), urinary incontinence (ICIQ-UI), (MLUTS/FLUTS) and (MLUTSsex/FLUTSsex), physical activity level from Danish National Health Profile and finding meaning in life (SOME).\n\nObjective measures will be collected at 6 weeks, 6 months, 12 months and 24 months and include: Anorectal manometry that measures anorectal muscle function and rectal perception, a digital examination of anorectal muscle function using the Digital Rectal Examination Scoring System (DRESS) and the six-minute walk test a measure of submaximal exercise capacity.\n\nWe plan to analyze the EDFI-Cohort study as repeated measures with both simple and multiple linear regression models for the continuous data. We plan to adjust for known confounders and variables related to treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects for the EDFI-Cohort study will be recruited during 2019 and 2020 from Department of Surgery, Slagelse, and Zealand University Hospital, Køge. Subjects need to be diagnosed with rectal cancer and have received curative surgery (low anterior resection) with/without adjuvant (radiation/chemo) therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of rectal cancer\n* Low anterior resection (e.g. not limited to total mesorectal excision (TME) or partial mesorectal excision (PME))\n* Ability to communicate in Danish\n* Adults (\\> 18 years of age)\n* American Society of Anaesthesiologists (ASA) score: I-IV.\n\nExclusion Criteria:\n\n* ASA score of: V-VI.'}, 'identificationModule': {'nctId': 'NCT03257332', 'acronym': 'EDFI-Cohort', 'briefTitle': 'Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Surgery for Rectal Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'Slagelse Hospital'}, 'officialTitle': 'The EDFI-Cohort: Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Curative Surgery for Rectal Cancer.', 'orgStudyIdInfo': {'id': 'EDFI-Cohort'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EDFI Cohort', 'description': 'Subjects should have received surgery for rectal cancer (low anterior resection).', 'interventionNames': ['Procedure: Low Anterior Resection for Rectum Cancer']}], 'interventions': [{'name': 'Low Anterior Resection for Rectum Cancer', 'type': 'PROCEDURE', 'otherNames': ['Total mesorectal excision', 'Partial mesorectal excision'], 'description': 'Subjects should have received curative surgery for rectal cancer (low anterior resection) with/with-out adjuvant (radiation/chemo) therapy.', 'armGroupLabels': ['EDFI Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-4600', 'city': 'Køge', 'state': 'Region Sjælland', 'country': 'Denmark', 'facility': 'Zealand University Hospital', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}, {'zip': 'DK-4200', 'city': 'Slagelse', 'state': 'Region Sjælland', 'country': 'Denmark', 'facility': 'Slagelse Hospital', 'geoPoint': {'lat': 55.40276, 'lon': 11.35459}}], 'overallOfficials': [{'name': 'Søren T Skou, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Slagelse Sygehus'}, {'name': 'Ismail Gögenur, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Zealand University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Reseachers whom are interested in study data, are welcome to contact study PI.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Slagelse Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zealand University Hospital', 'class': 'OTHER'}, {'name': 'Association of Danish Physiotherapists', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist and PhD', 'investigatorFullName': 'Brian Clausen', 'investigatorAffiliation': 'Slagelse Hospital'}}}}