Anorectal Function in Perianal Crohn's Disease

NCT ID: NCT03819257

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-19
• Study Completion Date: 2020-02-22

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with perianal Crohn's disease.

Endoanal ultrasound

Intervention Type: 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

Intervention Type: 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.

Balloon expulsion test

Intervention Type: 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.

Interventions

Endoanal ultrasound

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

Intervention Type: DIAGNOSTIC_TEST

High-resolution anorectal manometry

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.

Intervention Type: DIAGNOSTIC_TEST

Balloon expulsion 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

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 as hemorrhoidectomy or lateral sphincterotomy

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Leeds Teaching Hospital NHS Trust

Leeds, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 34945205 (View on PubMed)

Other Identifiers

GA18/113514

Identifier Type: -

Identifier Source: org_study_id