NCT05351034

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

1.5 years

First QC Date

April 2, 2022

Last Update Submit

April 22, 2022

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline

Secondary Outcomes (5)

  • Detect the average resting anal pressure among patients with inactive IBD

    baseline

  • Detect the average anal pressure changes in respond to squeeze and cough among patients with inactive IBD

    baseline

  • assess rectal sensation among patients with inactive IBD

    baseline

  • Estimate recto-anal coordination in patients with inactive IBD

    baseline

  • Estimate the anal sphincter inhibition in response to sudden change in rectal pressure ( RAIR ) in patients with inactive IBD

    baseline

Interventions

Anorectal manometryDEVICE

Anorectal manometry in diagnosis of Functional anorectal disorders

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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: 30096985BACKGROUND

  • 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: 21214889BACKGROUND

  • 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: 24026401BACKGROUND

  • 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: 15500515BACKGROUND

  • 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: 29636555BACKGROUND

  • 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.

    PMID: 32935278BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Andrew Nader Ramzy Tamer, M.Sc

CONTACT

+201009673113andrew_tamer@med.aun.edu.eg

Ahmed M. Ashmawy, PhD

CONTACT

+201005679880Dr.ashmawy82@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

April 2, 2022

First Posted

April 28, 2022

Study Start

June 1, 2022

Primary Completion

December 1, 2023

Study Completion

April 1, 2024

Last Updated

April 28, 2022

Record last verified: 2022-04