Anorectal Function in Perianal Crohn's Disease

Completed

• Conditions: Crohn Disease
• Interventions: Diagnostic Test: Endoanal ultrasound; Diagnostic Test: High-resolution anorectal manometry; Diagnostic Test: Balloon expulsion test

• Registration Number: NCT03819257
• Lead Sponsor: The Leeds Teaching Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-18
• Study Start: 2019-01-19
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-28
• Status Verified: 2020-02
• Primary Completion: 2020-02-22
• Study Completion: 2020-02-22
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 fulfill 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 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).

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with perianal Crohn's disease.	Endoanal ultrasound	-
Patients with perianal Crohn's disease.	High-resolution anorectal manometry	-
Patients with perianal Crohn's disease.	Balloon expulsion test	-

Primary Outcome Measures

Name	Time	Method
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.	30 minutes	Evaluated by high-resolution anorectal manometry.
Anal sphincters integrity.	5 minutes	Evaluated by endoanal ultrasound.
Ballon expulsion test duration.	3 minutes

Secondary Outcome Measures

Name	Time	Method
Presence of symptoms suggesting obstructed defection.	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.

Trial Locations

Locations (1)

Leeds Teaching Hospital NHS Trust; 🇬🇧 Leeds, United Kingdom