MRI-Based Screening in a Retrospective Cohort Reveals Adverse Prognosis of Asymptomatic Perianal Fistulas in Crohn's Disease: A Long-term Follow-Up Study

NCT07555808 | Completed

• 1 other identifier: E2025277
• Study Type: observational
• Target: 669
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to learn about the necessity of imaging screening for perianal fistula in Crohn's disease (CD) patients without perianal symptoms by comparing the natural history and long-term outcomes between those with asymptomatic perianal fistula (APF) and those with symptomatic perianal fistulizing Crohn's disease (PFCD). The main questions it aims to answer are: Does the early detection of asymptomatic perianal fistula through routine MRI screening lead to a better long-term prognosis in CD patients? How do the clinical courses and long-term outcomes compare between CD patients with asymptomatic perianal fistula (APF) and those with symptomatic perianal fistula (PFCD)? In accordance with our center's standard operating procedure (SOP), all patients with suspected CD underwent perianal MRI, regardless of perianal symptoms. Participants were retrospectively enrolled into a dedicated CD cohort at our center between 2010 and 2019. For this study, patients from this cohort who were diagnosed with perianal fistula at initial diagnosis will be retrospectively assessed. They were initially classified into the APF group or the symptomatic PFCD (control) group based on the presence of perianal symptoms at diagnosis. Using advanced statistical methods, the study will compare the risks of major disease complications, treatment initiation patterns, and overall disease progression between these two groups over years of follow-up.

Conditions

Crohn's Disease

Keywords

Crohn's disease; asymptomatic perianal fistula; perianal magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• CD-related intestinal surgery

  CD-related intestinal surgeries included intestinal resection, ostomy creation, and similar procedures. The onset of a CD-related intestinal surgery was defined as the time point when it was first detected on imaging during follow-up.

  Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2024, whichever occurred first.

Secondary Outcomes (4)

• intestinal stricture

  Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2024, whichever occurred first.

• intestinal fistula

  Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2024, whichever occurred first.

• Medically difficult-to-treat status

  Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2024, whichever occurred first.

• clinically prioritized composite endpoint

  Follow-up began at diagnosis and ended at death, loss to follow-up, or December 31, 2024, whichever occurred first.

Study Arms (2)

asymptomatic perianal fistula group

pelvic magnetic resonance imaging (MRI) indicated the presence of perianal fistulas at initial CD diagnosis; absence of pre-diagnosis perianal symptoms (including perianal complaints and previous perianal surgery)

symptomatic perianal fistulizing Crohn's disease (PFCD) group

pelvic magnetic resonance imaging (MRI) indicated the presence of perianal fistulas at initial CD diagnosis; presence of pre-diagnosis perianal symptoms (including perianal complaints and previous perianal surgery)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

the CD patients diagnosed between January 1, 2010, and December 31, 2019, enrolled from the prospective CD database in our IBD center, who also had perianal fistula confirmed by pelvic MRI within 3 months before or after initial CD diagnosis. Those with incomplete records or less than 5 years of follow-up were excluded. Patients were classified into the APF group or the symptomatic perianal fistulizing Crohn's disease (PFCD) group (control) based on the presence of pre-diagnosis perianal symptoms (including perianal complaints and previous perianal surgery).

You may qualify if:

• CD patients diagnosed between January 1, 2010, and December 31, 2019;
• had perianal fistula confirmed by pelvic MRI within 3 months before or after initial CD diagnosis;
• prospective follow-up in our IBD center;

You may not qualify if:

• with incomplete records;
• less than 5 years of follow-up;

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

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: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: April 29, 2026
• Study Start: January 1, 2010
• Primary Completion: December 31, 2019
• Study Completion: January 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share