Calprotectin in patients with perianal fistulas: the CANALS study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 70

Inclusion Criteria

Crohn's perianal fistulas:

•Patients = 16 years old
•Established Crohn diagnosis, based on a combination of history, physical examination, family history, laboratory tests, endoscopy tests including histopathologic examination of mucosal bi-opsies, imaging studies and occasionally intraoperative findings
•Active perianal fistula as defined by spontaneous drainage or drainage upon gentle finger com-pression
•Clinical indication for surgical examination or intervention under anesthesia at discretion of the treating physician at the outpatients surgery center of the Amsterdam UMC, location AMC
•Written informed consent

Cryptoglandular perianal fistulas:

•Patients = 16 years old
•Established diagnosis of a cryptoglandular perianal fistula, based on a combination of history and physical examination and supplemented by the prior exclusion of Crohn’s disease by at least one previous endoscopy
•Active perianal fistula as defined by spontaneous drainage or drainage upon gently finger com-pression
•Clinical indication for surgical examination or intervention under anesthesia at discretion of the treating physician at the outpatients surgery center
•Written informed consent

Exclusion Criteria

Crohn's perianal fistulas:

•Age < 16 years at inclusion
•Perianal abscess > 2cm on MRI and/or clear clinical signs of an perianal abscess that requires surgical incision and drainage.
•Perianal hidradenitis suppurativa
•Clinical signs of an infectious gastroenteritis
•Patients with an ileostomy or colostomy
•No internal opening during surgical examination

Cryptoglandular perianal fistulas:

•Age < 16 years at inclusion
•Perianal abscess
•Perianal hidradenitis suppurativa
•Clinical signs of an infectious gastroenteritis
•No internal opening during surgical examination

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Determine the diagnostic accuracy of faecal calprotectin for differentiating between active Crohn’s disease perianal fistulas and cryptoglandular perianal fistulas

Secondary Outcome Measures