Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-28 @ 1:44 AM
Study NCT ID:
NCT04741893
Status:
COMPLETED
Last Update Posted:
2021-02-05
First Post:
2018-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anal Canal Functional Assessment Using EndoFLIP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004688', 'term': 'Encopresis'}, {'id': 'D058070', 'term': 'Asymptomatic Diseases'}], 'ancestors': [{'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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-03', 'studyFirstSubmitDate': '2018-02-19', 'studyFirstSubmitQcDate': '2021-02-03', 'lastUpdatePostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in anal distensibility with age in asymptomatic individuals assessed with EndoFLIP', 'timeFrame': '1 day', 'description': 'Comparison of anal distensibility in between different age groups in asymptomatic individuals'}, {'measure': 'Abnormal anal distensibility in faecally incontinent group', 'timeFrame': '1 day', 'description': 'Comparison of anal distensibility between faecally incontinent patients and asymptomatic individuals using EndoFLIP'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Faecal incontinence', 'Functional Lumen Imaging Probe', 'Anal distensibility'], 'conditions': ['Faecal Incontinence', 'Asymptomatic Condition']}, 'referencesModule': {'references': [{'pmid': '5212375', 'type': 'BACKGROUND', 'citation': 'Harris LD, Winans CS, Pope CE 2nd. Determination of yield pressures: a method for measuring anal sphincter competence. Gastroenterology. 1966 Jun;50(6):754-60.'}, {'pmid': '24286561', 'type': 'BACKGROUND', 'citation': 'Sorensen G, Liao D, Lundby L, Fynne L, Buntzen S, Gregersen H, Laurberg S, Krogh K. Distensibility of the anal canal in patients with idiopathic fecal incontinence: a study with the Functional Lumen Imaging Probe. Neurogastroenterol Motil. 2014 Feb;26(2):255-63. doi: 10.1111/nmo.12258. Epub 2013 Nov 29.'}, {'pmid': '26670599', 'type': 'BACKGROUND', 'citation': 'Gourcerol G, Granier S, Bridoux V, Menard JF, Ducrotte P, Leroi AM. Do endoflip assessments of anal sphincter distensibility provide more information on patients with fecal incontinence than high-resolution anal manometry? Neurogastroenterol Motil. 2016 Mar;28(3):399-409. doi: 10.1111/nmo.12740. Epub 2015 Dec 15.'}]}, 'descriptionModule': {'briefSummary': "Faecal incontinence (FI) is characterized by involuntary loss of rectal content through the anal canal. FI is psychologically and socially debilitating problem that can dramatically affect patient's quality of life, often in otherwise healthy individual. FI can occur as a result of obstetric sphincter injury, surgery, irradiation, anorectal malformations as well as neurological, connective tissue or endocrine disorders. Currently management options for these patients are limited, partly due to the fact that control of defaecation and continence is multifactorial but also due to the fact that FI is difficult to identify the exact cause of patients' incontinence.\n\nCurrent assessment of patients with FI include endoscopic assessment to rule out intraluminal organic cause for patients' symptoms, endoanal ultrasound scan / MRI to assess their pelvic floor anatomy and anorectal manometry to assess anorectal function. Anorectal manometry is a simple test to perform but Anorectal manometry is susceptible to measurement artifacts, with a high inter-individual variation with significant overlap between healthy asymptomatic and symptomatic patients with FI. Harris et al in 1966 suggested that the anal sphincter's resistance to distension that may be of importance for sphincter competence, not how tight anal sphincter can squeeze.\n\nEndoluminal Functional Lumen Imaging Probe (EndoFLIP©) is a novel technology used to measure the dimensions and function of a hollow organ. Limited publication so far has shown that EndoFLIP© provides a new way of assessing anal sphincter competence. The study is to assess the use of EndoFLIP© to assess anal sphincter function in Hong Kong population. Firstly to evaluate whether age has an effect on the distensibility of the anal sphincter and its function and secondly to compare between symptomatic patients with faecal incontinence and asymptomatic healthy subjects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'For Asymptomatic Group:\n\nInclusion Criteria: adults over 30 with no history of faecal incontinence, who are able to give consent.\n\nExclusion Criteria: Patients with history of gastrointestinal disease on medication or neurological disorder with bowel symptoms, anorectal surgery or previous bowel resection. Patients who are not willing to undergo the specified tests in this study. Pregnant women.\n\nFor Faecally Incontinent Group:\n\nInclusion Criteria: Adults over 30 with history of faecal incontinence for over 3months, who are able to give consent.\n\nExclusion Criteria: Patients who are not willing to undergo the specified tests in this study. Pregnant women and patients who has had anorectal surgery or bowel resection.'}, 'identificationModule': {'nctId': 'NCT04741893', 'briefTitle': 'Anal Canal Functional Assessment Using EndoFLIP', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Assessment of the Effect of Ageing on Anal Sphincter Distensibility in Hong Kong Using EndoFLIP', 'orgStudyIdInfo': {'id': 'CREC2017.125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'faecally incontinent patients', 'description': 'faecally incontinent patients are all assessed using EndoFLIP as well as anorectal manometry and endoanal ultrasound', 'interventionNames': ['Device: EndoFLIP']}, {'type': 'EXPERIMENTAL', 'label': 'Asymptomatic individuals', 'description': 'asymptomatic individuals are all assessed using EndoFLIP as well as anorectal manometry and endoanal ultrasound', 'interventionNames': ['Device: EndoFLIP']}], 'interventions': [{'name': 'EndoFLIP', 'type': 'DEVICE', 'description': 'Use of Endoluminal Functional Lumen Imaging Probe to assess anal canal function', 'armGroupLabels': ['Asymptomatic individuals', 'faecally incontinent patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin', 'state': 'New Territories', 'country': 'Hong Kong', 'facility': 'Department of Surgery, Chinese University of Hong Kong', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}], 'overallOfficials': [{'name': 'Kaori Futaba', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kaori Futaba', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}