Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-27 @ 11:34 PM
Study NCT ID:
NCT05351034
Status:
UNKNOWN
Last Update Posted:
2022-04-28
First Post:
2022-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of High-resolution Anorectal Manometry in the Diagnosis of Functional Anorectal Disorders in Patients With Inactive Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-22', 'studyFirstSubmitDate': '2022-04-02', 'studyFirstSubmitQcDate': '2022-04-22', 'lastUpdatePostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of functional anorectal disorders in patients with inactive inflammatory bowel disease with defecatory symptoms .', 'timeFrame': 'baseline', 'description': 'To detect the possible association between inactive inflammatory bowel disease and functional anorectal disorders.'}], 'secondaryOutcomes': [{'measure': 'Detect the average resting anal pressure among patients with inactive IBD', 'timeFrame': 'baseline', 'description': 'using anorectal manometry to detect the anal canal pressure during rest'}, {'measure': 'Detect the average anal pressure changes in respond to squeeze and cough among patients with inactive IBD', 'timeFrame': 'baseline', 'description': 'using anorectal manometry to detect the anal canal pressure during coughing and squeezing'}, {'measure': 'assess rectal sensation among patients with inactive IBD', 'timeFrame': 'baseline', 'description': 'using anorectal manometry balloon insufflation to detect the rectal sensation pressure'}, {'measure': 'Estimate recto-anal coordination in patients with inactive IBD', 'timeFrame': 'baseline', 'description': 'using anorectal manometry to detect the coordination of anal sphincter in response to push'}, {'measure': 'Estimate the anal sphincter inhibition in response to sudden change in rectal pressure ( RAIR ) in patients with inactive IBD', 'timeFrame': 'baseline', 'description': 'Sudden insufflation of the balloon lead to reflex inhibition of internal anal sphincter in normal individuals .'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases']}, 'referencesModule': {'references': [{'pmid': '30096985', 'type': 'BACKGROUND', 'citation': 'Sharara AI, Al Awadhi S, Alharbi O, Al Dhahab H, Mounir M, Salese L, Singh E, Sunna N, Tarcha N, Mosli M. Epidemiology, disease burden, and treatment challenges of ulcerative colitis in Africa and the Middle East. Expert Rev Gastroenterol Hepatol. 2018 Sep;12(9):883-897. doi: 10.1080/17474124.2018.1503052. Epub 2018 Aug 10.'}, {'pmid': '21214889', 'type': 'BACKGROUND', 'citation': 'Bryant RV, van Langenberg DR, Holtmann GJ, Andrews JM. Functional gastrointestinal disorders in inflammatory bowel disease: impact on quality of life and psychological status. J Gastroenterol Hepatol. 2011 May;26(5):916-23. doi: 10.1111/j.1440-1746.2011.06624.x.'}, {'pmid': '24026401', 'type': 'BACKGROUND', 'citation': 'Perera LP, Ananthakrishnan AN, Guilday C, Remshak K, Zadvornova Y, Naik AS, Stein DJ, Massey BT. Dyssynergic defecation: a treatable cause of persistent symptoms when inflammatory bowel disease is in remission. Dig Dis Sci. 2013 Dec;58(12):3600-5. doi: 10.1007/s10620-013-2850-3. Epub 2013 Sep 12.'}, {'pmid': '15500515', 'type': 'BACKGROUND', 'citation': 'Rao SS, Mudipalli RS, Stessman M, Zimmerman B. Investigation of the utility of colorectal function tests and Rome II criteria in dyssynergic defecation (Anismus). Neurogastroenterol Motil. 2004 Oct;16(5):589-96. doi: 10.1111/j.1365-2982.2004.00526.x.'}, {'pmid': '29636555', 'type': 'BACKGROUND', 'citation': 'Carrington EV, Scott SM, Bharucha A, Mion F, Remes-Troche JM, Malcolm A, Heinrich H, Fox M, Rao SS; International Anorectal Physiology Working Group and the International Working Group for Disorders of Gastrointestinal Motility and Function. Expert consensus document: Advances in the evaluation of anorectal function. Nat Rev Gastroenterol Hepatol. 2018 May;15(5):309-323. doi: 10.1038/nrgastro.2018.27. Epub 2018 Apr 11.'}, {'pmid': '32935278', 'type': 'BACKGROUND', 'citation': 'Scott SM, Carrington EV. The London Classification: Improving Characterization and Classification of Anorectal Function with Anorectal Manometry. Curr Gastroenterol Rep. 2020 Sep 15;22(11):55. doi: 10.1007/s11894-020-00793-z.'}]}, 'descriptionModule': {'briefSummary': 'The study aimed at diagnose and to detect the incidence of functional anorectal disorders in patients with inactive inflammatory bowel disease and to highlight the role of anorectal manometry in evaluating IBD patients with persistent defecatory dysfunction .', 'detailedDescription': 'Inflammatory bowel diseases (IBD) are chronic disorders of the gastrointestinal tract associated with debilitating symptoms due to immune mediated enteric inflammation. Western countries have been historically observed that IBD is prevalent and continues to rise, whereas the general impression is that countries in the Middle East (ME) experience a lower incidence of IBD. Incidence rates vary considerably depending on the region. In 2017, Ulcerative Colitis (UC) incidence rates ranged from 0.97 to 57.9 per 100,000 in Europe, 8.8 to 23.14 per 100,000 in North America, and 0.15 to 6.5 per 100,000 in Asia and the ME. Nonetheless, recent trends have shown a significant rise in the incidence of IBD in Middle East countries, which were linked to "westernization" in lifestyle, including dietary habits in these countries .\n\nUnfortunately IBD remains incurable .As a result, many patients experience intermittent flares of intestinal inflammation in an unpredictable relapsing-remitting pattern, with recognizable symptoms of increased bowel frequency, bleeding and urgency. While advances in the treatment of IBD in recent decades have increased the likelihood of achieving disease remission and mucosal healing, a significant proportion of patients still present with refractory gastrointestinal symptoms. In this context, there can be considerable overlap between symptoms in active IBD and overlapping coexisting functional gastrointestinal disorders in patients with quiescent disease.\n\nGiven the complexity of the normal continence and defecatory mechanism, it is unsurprising that disruption of one or more mechanism as a consequence of IBD can lead to either evacuatory dysfunction or fecal incontinence (FI) and multiple factors are involved in its pathogenesis.\n\nConventionally, Dyssynergic defecation ( DD) is an acquired behavioral disorder in which coordination is lacking between the pelvic floor/anal sphincter with abdominal muscles at the time of defecation. Among IBD patients, DD may be challenging to identify as it can present atypically with symptoms other than constipation, including urgency, rectal pain, sensation of incomplete evacuation, fecal incontinence, and frequent defecation.\n\nThis poses a significant challenge for clinicians, as failure to positively recognize functional disorders in patients without objective evidence of active inflammation, can lead to repeatedly negative and often invasive investigations, increased healthcare utilization, futile and potentially hazardous escalation of IBD therapies, and patient dissatisfaction due to refractory symptoms.\n\nAnorectal manometry (ARM) is the most important test to assess anorectal function and detect motor abnormalities of sphincter function and anorectal coordination. It is indicated in patients presenting with FI and chronic refractory constipation and suspected evacuatory dysfunction. ARM enables assessment of rectal sensation,reflexes, and compliance. The manometric equipment will be used to measure the resting tone of the anal canal, voluntary function during squeeze, and reflex recto-anal coordination during rectal distension. In addition, it allows assessment for dyssynergic patterns and recto-anal coordination during simulated defecation (\'push\'). It is therefore a useful test to confirm physiological abnormalities to select patients for biofeedback therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older with IBD ,\n* Patients have documented disease remission by endoscopy and laboratory data\n* Patients have persistent defecatory symptoms .\n\nExclusion Criteria:\n\n* Patients with a history of anorectal fistulizing / stricturing disease .\n* Patients with prior surgery involving the anorectum .'}, 'identificationModule': {'nctId': 'NCT05351034', 'briefTitle': 'The Role of High-resolution Anorectal Manometry in the Diagnosis of Functional Anorectal Disorders in Patients With Inactive Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Role of High-resolution Anorectal Manometry in the Diagnosis of Functional Anorectal Disorders in Patients With Inactive Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'HRAM in inactive IBD'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Anorectal manometry', 'type': 'DEVICE', 'description': 'Anorectal manometry in diagnosis of Functional anorectal disorders'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Andrew Nader Ramzy Tamer, M.Sc', 'role': 'CONTACT', 'email': 'andrew_tamer@med.aun.edu.eg', 'phone': '+201009673113'}, {'name': 'Ahmed M. Ashmawy, PhD', 'role': 'CONTACT', 'email': 'Dr.ashmawy82@gmail.com', 'phone': '+201005679880'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Andrew Nader Ramzy Tamer', 'investigatorAffiliation': 'Assiut University'}}}}