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
About this trial
This is an interventional diagnostic trial for Inflammatory Bowel Diseases
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 .
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
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
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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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