Crohn's disease perianal fistulas and cryptoglandular perianal fistulas
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
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
Exclusion criteria: Crohn's perianal fistulas: • Age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Determine the diagnostic accuracy of faecal calprotectin for differentiating between active Crohn’s disease perianal fistulas and cryptoglandular perianal fistulas | — |
Secondary
| Measure | Time frame |
|---|---|
| • Determine the diagnostic accuracy of faecal calprotectin for the presence of active intestinal inflammation in CD patients with an active perianal fistula • Determine local calprotectin production in an active fistula tract determined by fistula fluid and scrapings calprotectin concentration • Determine the association between the anatomical nature of the fistula tract (simple vs complex) and faecal calprotectin and fistula fluid and scrapings calprotectin concentrations • Determine the association between the epithelialization status of the fistula tract and faecal calprotectin and fistula fluid calprotectin concentrations • Determine the correlation between the Perianal Disease Activity Index (PDAI) and faecal calprotectin concentration • Determine the correlation between calprotectin concentration in faeces and fistula fluid • Determine the correlation between calprotectin concentration in fistula fluid and fistula scraping • Determine the correlation between calprotectin concentration in faeces and fistula scraping | — |
Contacts
Amsterdam UMC, location AMC