An observational study in Crohn Disease, sponsored by The Leeds Teaching Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-25.
Sponsored by The Leeds Teaching Hospitals NHS Trust · Observational
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 16 is below the median of 162 across 608 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →The Leeds Teaching Hospitals NHS Trust is the lead sponsor of 95 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients attending hospital with diagnosed perianal Crohn's disease.
Exclusion Criteria:
A previous seton placement, abscess drainage, fistulotomy and lay open fistula are not an 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.
Diagnostic Test: Endoanal ultrasound · Diagnostic Test: High-resolution anorectal manometry · Diagnostic Test: Balloon expulsion test
For the assessment of the internal and external anal sphincter integrity. To evaluate fistulas/perianal abscess and seton placement.
1. rest - basal anal pressures at rest over 60 s 2. squeeze - anal pressure during voluntary effort; long squeeze - anal pressure during sustained voluntary effort 3. cough - anorectal pressure changes during cough 4. push - anorectal pressure changes during simulated defecation 5. rectoanal inhibitory reflex - reflex anal response to rectal distension 6. rectal sensation - assessment of rectal sensitivity to distension.
A non-latex balloon will be inserted in the rectum after applying lubricating gel. This balloon is then filled with 50ml of warm water. The patient is ask to sit on a commode and to try to expel the device in privacy, while the time is being recorded. The test ends when the patient expelled the balloon or when 3 minutes are reach.
Resting pressure, squeezing pressure, anorectal pressure changes during cough, anorectal pressure changes during simulated defecation, presence of a rectoanal inhibitory reflex and assessment of rectal sensitivity to distension.
Evaluated by high-resolution anorectal manometry.
Time frame: 30 minutes
Anal sphincters integrity.
Evaluated by endoanal ultrasound.
Time frame: 5 minutes
Ballon expulsion test duration.
Time frame: 3 minutes
Presence of symptoms suggesting obstructed defection.
Prolonged and unsuccessful straining at stool, self-digitation for defecation, sense of incomplete evacuation or sensation of anorectal obstruction/blockage and a stool frequency of less than three times per week.
Time frame: 5 minutes
Wexner score (fecal incontinence score).
5 items score, including solid, liquid, gas incontinence, wearing pads and lifestyle alterations, scored from 0 (normal) to 4 (more severe).
Time frame: 5 minutes
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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The Leeds Teaching Hospitals NHS Trust