Crohn and Anal Incontinence

NCT04944797 | Withdrawn

• 1 other identifier: CRIA
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Determine the prevalence of anal incontinence in patients with Crohn's disease at expert gastroenterology and proctology centers in France. Anal incontinence is defined by a Cleveland or Jorge and Wexner score ≥ 5

  Percentage of patients with Crohn's disease with a Cleveland or Jorge and Wexner score ≥ 5

  Day 1

Secondary Outcomes (5)

• Compare the prevalence of anal incontinence in patients followed for Crohn's disease on gastroenterology services versus patients followed for ano-perineal involvement in Crohn's disease on a proctology service.

  Day 1

• Determine independent risk factors for anal incontinence in Crohn's disease regardless of Crohn's disease location

  Day 1

• Compare the quality of life of patients with anal incontinence vs. patients without anal incontinence with Crohn's disease

  Day 1

• Compare the quality of life of patients followed for Crohn's disease on gastroenterology services with anal incontinence versus patients followed for ano-perineal involvement of Crohn's disease on a proctology service with anal incontinence

  Day 1

• Compare the quality of life of patients with anoperineal involvement in Crohn's disease and anal incontinence versus patients with exclusive luminal involvement in Crohn's disease and anal incontinence

  Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be offered to consecutively selected patients who meet the eligibility criteria. These patients will be seen in one of the two study centers (gastroenterology and proctology departments at GHPSJ or gastroenterology department at Louis Mourier Hospital): * either in day hospital to carry out their treatment (infliximab, adalimumab, vedolizumab, ustekinumab, intravenous iron) * or in consultation for their classic follow-up.

You may qualify if:

• Patient whose age ≥ 18 years
• French-speaking patient
• Patient followed for Crohn's disease in one of the participating centers (gastroenterology or proctology departments of the Paris-Saint Joseph Hospital Group, gastroenterology department of the Louis Mourier Hospital). The diagnosis of Crohn's disease is based on clinical, endoscopic, radiological and histological criteria.

You may not qualify if:

• Patient with a functional stoma
• Patient who objects to participation in the study
• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient under court protection

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead
• Hôpital Louis Mourier: collaborator

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Vincent de Parades, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 30, 2021
• Study Start: March 30, 2022
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-03