Crohn's disease
Conditions
Interventions
None listed
Sponsors
None
Eligibility
Inclusion criteria
Inclusion criteria: Patients with Crohn’s perianal fistulas, defined as one or more perianal fistula tracts in patients with previously endoscopic or histologic confirmed Crohn’s disease.
Exclusion criteria
Exclusion criteria: • Presence of pelvic sepsis or abscesses at the time of study entry. • Perianal fistula is a rectovaginal fistula. • Any oncological event in the patients history in the previous five years. • Any other medical condition that in the judgement of the investigator could interfere with their optimal participation in the study or produce a significant risk to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical closure combined with radiographic closure of the fistula tract after surgical intervention at 6 months. Clinical closure of fistula tract is defined as closure of the external openings at physical examination. Radiographic closure is defined as the amount of percent decrease in luminal activity measured by hyper intensity on pelvic T2-weighted MRI. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Surgical data • Length of stay in the hospital • Postoperative complications (infection / bleeding) of the perianal and liposuction sites • Time to clinical healing. Clinical healing will be defined as closure of the internal and external opening at physical examination • Need of re-intervention and/or readmissions within 6 months follow up (depending on available time to follow-up) | — |
Contacts
Public ContactJeanine Arkenbosch
Erasmus MC
Outcome results
None listed