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Completed

NCT Number: NCT03819257

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Leeds Teaching Hospital NHS Trust

Leeds, LS7 4SA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 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
  • Asymptomatic or symptomatic patients (anorectal symptoms) will be included, as long they fulfill the other inclusion criteria, like for anorectal symptomatic patients having a PDAI≤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.

Exclusion criteria

  • 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).

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.

Treatment and study plan

Endoanal ultrasound

Diagnostic Test

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

High-resolution anorectal manometry

Diagnostic Test
  • rest - basal anal pressures at rest over 60 s
  • squeeze - anal pressure during voluntary effort; long squeeze - anal pressure during sustained voluntary effort
  • cough - anorectal pressure changes during cough
  • push - anorectal pressure changes during simulated defecation
  • rectoanal inhibitory reflex - reflex anal response to rectal distension
  • rectal sensation - assessment of rectal sensitivity to distension.

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.

Primary outcomes

  1. 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.

    Time frame: 30 minutes

    Evaluated by high-resolution anorectal manometry.

  2. Anal sphincters integrity.

    Time frame: 5 minutes

    Evaluated by endoanal ultrasound.

  3. Ballon expulsion test duration.

    Time frame: 3 minutes

Secondary outcomes

  1. Presence of symptoms suggesting obstructed defection.

    Time frame: 5 minutes

    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.

Other outcomes

  1. Wexner score (fecal incontinence score).

    Time frame: 5 minutes

    5 items score, including solid, liquid, gas incontinence, wearing pads and lifestyle alterations, scored from 0 (normal) to 4 (more severe).

Sponsors and collaborators

Lead sponsor

The Leeds Teaching Hospitals NHS Trust

Other

Registry information

Official study title

Evaluation of Anorectal Function in Perianal Crohn's Disease: a Pilot Study.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 28, 2019
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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