- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05351034
The Role of High-resolution Anorectal Manometry in the Diagnosis of Functional Anorectal Disorders in Patients With Inactive Inflammatory Bowel Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Andrew Nader Ramzy Tamer, M.Sc
- Phone Number: +201009673113
- Email: andrew_tamer@med.aun.edu.eg
Study Contact Backup
- Name: Ahmed M. Ashmawy, PhD
- Phone Number: +201005679880
- Email: Dr.ashmawy82@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of functional anorectal disorders in patients with inactive inflammatory bowel disease with defecatory symptoms .
Time Frame: baseline
|
To detect the possible association between inactive inflammatory bowel disease and functional anorectal disorders.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detect the average resting anal pressure among patients with inactive IBD
Time Frame: baseline
|
using anorectal manometry to detect the anal canal pressure during rest
|
baseline
|
Detect the average anal pressure changes in respond to squeeze and cough among patients with inactive IBD
Time Frame: baseline
|
using anorectal manometry to detect the anal canal pressure during coughing and squeezing
|
baseline
|
assess rectal sensation among patients with inactive IBD
Time Frame: baseline
|
using anorectal manometry balloon insufflation to detect the rectal sensation pressure
|
baseline
|
Estimate recto-anal coordination in patients with inactive IBD
Time Frame: baseline
|
using anorectal manometry to detect the coordination of anal sphincter in response to push
|
baseline
|
Estimate the anal sphincter inhibition in response to sudden change in rectal pressure ( RAIR ) in patients with inactive IBD
Time Frame: baseline
|
Sudden insufflation of the balloon lead to reflex inhibition of internal anal sphincter in normal individuals .
|
baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRAM in inactive IBD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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