Ignite Creation Date:
2024-05-06 @ 4:18 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04944797
Status:
WITHDRAWN
Last Update Posted:
2022-04-07
First Post:
2021-06-15
Brief Title:
Crohn and Anal Incontinence
Sponsor:
Fondation Hôpital Saint-Joseph
Organization:
Fondation Hôpital Saint-Joseph
Study Overview
Official Title:
Prevalence Risk Factors and Impact of Anal Incontinence in Patients Followed for Crohns Disease
Status:
WITHDRAWN
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The project was abandoned
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRIA
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 andor 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
Crohns 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 Crohns 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 Crohns 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 Crohns disease Of the 3264 patients who responded to this questionnaire 325 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 Crohns 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 Crohns disease
Crohns 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 Crohns 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 Crohns 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 Crohns disease Of the 3264 patients who responded to this questionnaire 325 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 Crohns 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 Crohns disease
Detailed Description:
Many risk factors for anal incontinence have been identified in the general population In IBD the risk factors associated with anal incontinence are gender age a history of anal stenosis a history of anal fistula surgery and a history of colorectal surgery There is currently only one study that has identified risk factors for anal incontinence specific to Crohns disease In this study the risk factors for anal incontinence were loose stools a history of colonic or bowel resection related to Crohns disease a stenosing phenotype of Crohns disease and ano-perineal involvement in Crohns disease
The impact of anal incontinence on quality of life is major Numerous trials show that this handicap is underestimated because of its shameful embarrassing and intimate nature The deterioration of quality of life evaluated by the Inflammatory Bowel Disease Questionnaire IBDQ or Fecal Incontinence Quality-of-Life FIQL scores is associated with the severity of anal incontinence in IBD It is significantly degraded when there are several
episodes of weekly anal incontinence in patients followed for Crohns disease Only one study compared the quality of life of patients with ano-perineal involvement related to Crohns disease with that of patients with only colonic or intestinal involvement A significant deterioration in quality of life was reported in those with anoperineal involvement related to Crohns disease
One of the therapeutic targets to be achieved in Crohns disease is the patient related outcomes PRO ie the functional handicap secondary to the disease that is reported by the patient Anal incontinence is one of the disabilities related to Crohns disease The aim of treatment is to stop the handicap and thus to improve the quality of life
The aim of this study is to evaluate the prevalence risk factors and impact on quality of life of anal incontinence in a French cohort of patients with Crohns disease
The impact of anal incontinence on quality of life is major Numerous trials show that this handicap is underestimated because of its shameful embarrassing and intimate nature The deterioration of quality of life evaluated by the Inflammatory Bowel Disease Questionnaire IBDQ or Fecal Incontinence Quality-of-Life FIQL scores is associated with the severity of anal incontinence in IBD It is significantly degraded when there are several
episodes of weekly anal incontinence in patients followed for Crohns disease Only one study compared the quality of life of patients with ano-perineal involvement related to Crohns disease with that of patients with only colonic or intestinal involvement A significant deterioration in quality of life was reported in those with anoperineal involvement related to Crohns disease
One of the therapeutic targets to be achieved in Crohns disease is the patient related outcomes PRO ie the functional handicap secondary to the disease that is reported by the patient Anal incontinence is one of the disabilities related to Crohns disease The aim of treatment is to stop the handicap and thus to improve the quality of life
The aim of this study is to evaluate the prevalence risk factors and impact on quality of life of anal incontinence in a French cohort of patients with Crohns disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None