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The Role of High-resolution Anorectal Manometry in the Diagnosis of Functional Anorectal Disorders in Patients With Inactive Inflammatory Bowel Disease

Primary Purpose

Inflammatory Bowel Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Anorectal manometry
Sponsored by
Assiut University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 18 years or older with IBD ,
  • Patients have documented disease remission by endoscopy and laboratory data
  • Patients have persistent defecatory symptoms .

Exclusion Criteria:

  • Patients with a history of anorectal fistulizing / stricturing disease .
  • Patients with prior surgery involving the anorectum .

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Incidence of functional anorectal disorders in patients with inactive inflammatory bowel disease with defecatory symptoms .
    To detect the possible association between inactive inflammatory bowel disease and functional anorectal disorders.

    Secondary Outcome Measures

    Detect the average resting anal pressure among patients with inactive IBD
    using anorectal manometry to detect the anal canal pressure during rest
    Detect the average anal pressure changes in respond to squeeze and cough among patients with inactive IBD
    using anorectal manometry to detect the anal canal pressure during coughing and squeezing
    assess rectal sensation among patients with inactive IBD
    using anorectal manometry balloon insufflation to detect the rectal sensation pressure
    Estimate recto-anal coordination in patients with inactive IBD
    using anorectal manometry to detect the coordination of anal sphincter in response to push
    Estimate the anal sphincter inhibition in response to sudden change in rectal pressure ( RAIR ) in patients with inactive IBD
    Sudden insufflation of the balloon lead to reflex inhibition of internal anal sphincter in normal individuals .

    Full Information

    First Posted
    April 2, 2022
    Last Updated
    April 22, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05351034
    Brief Title
    The Role of High-resolution Anorectal Manometry in the Diagnosis of Functional Anorectal Disorders in Patients With Inactive Inflammatory Bowel Disease
    Official Title
    The Role of High-resolution Anorectal Manometry in the Diagnosis of Functional Anorectal Disorders in Patients With Inactive Inflammatory Bowel Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2022 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    April 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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 .
    Detailed Description
    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 . Unfortunately 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. Given 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. Conventionally, 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. This 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. Anorectal 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammatory Bowel Diseases

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Investigator
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Anorectal manometry
    Intervention Description
    Anorectal manometry in diagnosis of Functional anorectal disorders
    Primary Outcome Measure Information:
    Title
    Incidence of functional anorectal disorders in patients with inactive inflammatory bowel disease with defecatory symptoms .
    Description
    To detect the possible association between inactive inflammatory bowel disease and functional anorectal disorders.
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    Detect the average resting anal pressure among patients with inactive IBD
    Description
    using anorectal manometry to detect the anal canal pressure during rest
    Time Frame
    baseline
    Title
    Detect the average anal pressure changes in respond to squeeze and cough among patients with inactive IBD
    Description
    using anorectal manometry to detect the anal canal pressure during coughing and squeezing
    Time Frame
    baseline
    Title
    assess rectal sensation among patients with inactive IBD
    Description
    using anorectal manometry balloon insufflation to detect the rectal sensation pressure
    Time Frame
    baseline
    Title
    Estimate recto-anal coordination in patients with inactive IBD
    Description
    using anorectal manometry to detect the coordination of anal sphincter in response to push
    Time Frame
    baseline
    Title
    Estimate the anal sphincter inhibition in response to sudden change in rectal pressure ( RAIR ) in patients with inactive IBD
    Description
    Sudden insufflation of the balloon lead to reflex inhibition of internal anal sphincter in normal individuals .
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients aged 18 years or older with IBD , Patients have documented disease remission by endoscopy and laboratory data Patients have persistent defecatory symptoms . Exclusion Criteria: Patients with a history of anorectal fistulizing / stricturing disease . Patients with prior surgery involving the anorectum .
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrew Nader Ramzy Tamer, M.Sc
    Phone
    +201009673113
    Email
    andrew_tamer@med.aun.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed M. Ashmawy, PhD
    Phone
    +201005679880
    Email
    Dr.ashmawy82@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30096985
    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.
    Results Reference
    background
    PubMed Identifier
    21214889
    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.
    Results Reference
    background
    PubMed Identifier
    24026401
    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.
    Results Reference
    background
    PubMed Identifier
    15500515
    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.
    Results Reference
    background
    PubMed Identifier
    29636555
    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.
    Results Reference
    background
    PubMed Identifier
    32935278
    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.
    Results Reference
    background

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    The Role of High-resolution Anorectal Manometry in the Diagnosis of Functional Anorectal Disorders in Patients With Inactive Inflammatory Bowel Disease

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