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Crohn and Anal Incontinence

NCT04944797 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-04-07

No results posted yet for this study

Summary

Anal incontinence affects nearly 5% of the adult population in France. It is defined as the inability for a subject to retain matter and/or gas, outside of voluntary defecation episodes. It results in an uncontrolled loss of gas or stool through the anus. To quantify, anal incontinence clinical scores have been developed of which the most used is the Cleveland score (Jorge and Wexner). A Cleveland score ≥ 5 corresponds to anal incontinence.

Crohn's disease is a chronic inflammatory disease that can affect the entire digestive tract as well as the anus. It leads to destruction of the intestinal wall if not treated early.

The presence of ano-perineal involvement is a factor of severity and poor prognosis of Crohn's disease. The management of these ano-perineal lesions is particularly difficult because of the risks of destruction of the anal sphincter and recurrence of these lesions, as well as the consequences that they induce on anal continence, sexuality and quality of life.

The prevalence of anal incontinence in Crohn's disease has been assessed in three studies by self-questionnaires. In 2013, it was studied in a cohort of British patients followed for chronic inflammatory bowel disease (IBD) (Hemorrhagic rectocolitis or Crohn's disease). Of the 3264 patients who responded to this questionnaire (32.5% of the cohort), 74% claimed to have anal incontinence and in 40% of cases it occurred regularly or a few times. In a study of 184 patients treated at an IBD expert center in Sri Lanka, anal incontinence was reported to be 26%. Only 5 patients reported regular anal incontinence. Vollebregt et al specifically studied the prevalence of anal incontinence in patients followed for Crohn's disease in a Dutch expert center. Of the 325 responses (62%), 20% of patients reported having had an episode of anal incontinence in the last 4 weeks.

In these studies, the prevalence of anal incontinence varies according to the definition of anal incontinence (qualitative or quantitative estimate) and the population studied. No French study has been published on the prevalence of anal incontinence in Crohn's disease.

Conditions

  • Crohn Disease

Sponsors & Collaborators

  • Hôpital Louis Mourier

    collaborator OTHER

  • Fondation Hôpital Saint-Joseph

    lead OTHER

Principal Investigators

  • Vincent de Parades, MD · Fondation Hôpital Saint-Joseph

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-30
Primary Completion
2022-03-30
Completion
2022-03-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04944797 on ClinicalTrials.gov