Anorectal Function in Perianal Crohn's Disease

NCT03819257 | Completed

• 1 other identifier: GA18/113514
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (3)

• 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.

  30 minutes

• Anal sphincters integrity.

  Evaluated by endoanal ultrasound.

  5 minutes

• Ballon expulsion test duration.

  3 minutes

Secondary Outcomes (1)

• Presence of symptoms suggesting obstructed defection.

  5 minutes

Other Outcomes (1)

• Wexner score (fecal incontinence score).

  5 minutes

Study Arms (1)

Patients with perianal Crohn's disease.

Diagnostic Test: Endoanal ultrasound; Diagnostic Test: High-resolution anorectal manometry; Diagnostic Test: Balloon expulsion test

Interventions

Endoanal ultrasound DIAGNOSTIC_TEST

For the assessment of the internal and external anal sphincter integrity. To evaluate fistulas/perianal abscess and seton placement.

Patients with perianal Crohn's disease.

High-resolution anorectal manometry DIAGNOSTIC_TEST

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.

Patients with perianal Crohn's disease.

Balloon expulsion test DIAGNOSTIC_TEST

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.

Patients with perianal Crohn's disease.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending hospital with diagnosed perianal Crohn's disease.

You may qualify if:

• ≥ 18 and ≤ 75 year-old patients
• CD in clinical remission, defined by a Harvey-Bradshaw index \<5
• Perianal CD history, defined by the presence of a perianal fistula and/or abscess that were treated/heal/inactive
• Perianal Disease Activity Index (PDAI) of ≤4
• Endoanal ultrasound without an image compatible with new/non-treated abscess or perianal fistula
• Both previous simple or complex perianal fistula (according to the American College of Gastroenterology) will be considered.

You may not qualify if:

• Women with previous vaginal delivery
• Ileostomy
• Previous anorectal surgery as hemorrhoidectomy or lateral sphincterotomy
• 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
• Previous or current anal fissure
• Anal stricture
• Current or previous rectovaginal fistula (previous/last pelvic MRI).

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

Leeds Teaching Hospital NHS Trust

Leeds, LS7 4SA, United Kingdom

Location

Related Publications (1)

• Albuquerque A, Casey J, Fairlamb G, Houghton LA, Selinger C. Evaluation of Anorectal Function in Perianal Crohn's Disease: A Pilot Study. J Clin Med. 2021 Dec 16;10(24):5909. doi: 10.3390/jcm10245909.

  PMID: 34945205 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 28, 2019
• Study Start: January 19, 2019
• Primary Completion: February 22, 2020
• Study Completion: February 22, 2020
• Last Updated: February 25, 2020

Record last verified: 2020-02

Locations

GB (1)