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Calprotectin in patients with perianal fistulas: the CANALS study

Calprotectin in patients with perianal fistulas: the CANALS study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28117
Enrollment
70
Registered
2019-03-26
Start date
2019-03-26
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease perianal fistulas and cryptoglandular perianal fistulas

Interventions

None listed

Sponsors

none
Lead Sponsor

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

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

Secondary

MeasureTime 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

Public ContactToer Stevens

Amsterdam UMC, location AMC

t.w.stevens@amc.uva.nl0205665584

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)