Anorectal Function in Perianal Crohn's Disease
Perianal Crohn's disease is a disabling disease associated with increased morbidity and impaired quality of life. It is associated with pain, discharge, fecal incontinence and sexual and psychological impairment. In refractory cases, a stoma may be necessary. A higher prevalence is seen with increasing Crohn's disease duration and appears to vary according to the disease location. The presence of symptoms associated with anorectal dysfunction, such as fecal incontinence, can sometimes poorly correlate with the presence of anal sphincter abnormalities. Moreover, even in patients without symptoms, the presence of anal sphincter abnormalities may have important implications for the future selection of type of delivery, and might even pose a contra-indication for certain types of anorectal surgeries. Studies evaluating possible chronic complications of perianal Crohn's disease on anorectal function are lacking. There is a need for a better understanding of the chronic complications of this disease, and the role of high-resolution anorectal manometry in diagnosing these abnormalities during follow-up of these patients. This study will evaluate the chronic repercussions of perianal Crohn's disease in patients with a previous anal fistula and/or abscess that has healed and/or is inactive.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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|Eligible Ages||18 Years - 75 Years|
Inclusion Criteria:1. ≥ 18 and ≤ 75 year-old patients 2. CD in clinical remission, defined by a Harvey-Bradshaw index <5 3. Perianal CD history, defined by the presence of a perianal fistula and/or abscess that were treated/heal/inactive. 4. Perianal Disease Activity Index (PDAI) of ≤4 5. Asymptomatic or symptomatic patients (anorectal symptoms) will be included, as long they fulfil the other inclusion criteria, like for anorectal symptomatic patients having a PDAI≤4. 6. Endoanal ultrasound without an image compatible with new/non-treated abscess or perianal fistula. 7. Both previous simple or complex perianal fistula (according to the American College of Gastroenterology) will be considered
Exclusion Criteria:1. Women with previous vaginal delivery 2. Ileostomy 3. Previous anorectal surgery, including abscess drainage or fistulotomy, but not seton placement 4. Active rectal disease. No rectal involvement will be defined by no previous rectal involvement ever described or if previous involvement, endoscopy within 18 months showing no current involvement. 5. Previous or current anal fissure 6. Anal stricture 7. Current or previous rectovaginal fistula (previous/last pelvic MRI) A previous seton history is not and exclusion criteria. Patients with a current seton can only be included if the seton was place more than 24 weeks ago, and the endoanal ultrasound does not show any new/non-treated perianal fistula/abscess.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|The Leeds Teaching Hospitals NHS Trust|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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Leeds Teaching Hospital NHS Trust
Leeds, , LS7 4SA
Andreia Albuquerque, MD