Permacol Paste in Perianal Crohn's Disease (UPpCro)

Istituto Clinico Humanitas

Status: Unknown

Conditions: Perianal Fistula; Crohn Disease

Treatments: Device: Permacol Paste

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03776825

2134

Details and patient eligibility

About

The purpose of this study is to collect data about the efficacy of Permacol Paste treatment in perianal Crohn's Disease.

Full description

This is an observational prospective cohort study aimed to assess the efficacy of Permacol Paste treatment in perianal Crohn's Disease, by evaluating the healing rate and quality of life of 20 patients prospectively indicated to Permacol Paste treatment during one year.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18, any sex
• Diagnosis of CD at least 6 months earlier in accordance with clinical, endoscopic, histological an/or radiological criteria
• Presence of perianal fistulas with maximum 3 external openings and a maximum of 2 internal openings, assessed by physical examination and MRI
• Non-active or mildly active luminal CD defined by a CDAI < 220

Exclusion criteria

• CDAI > 220
• Dominant luminal active CD requiring immediate surgical or medical therapy
• Fistula with > 3 external openings and > 2 internal openings
• Severe active proctitis and/or rectal stenosis
• Abscess or pelvic collection > 2 cm diameter
• Concomitant rectovaginal fistulas
• Concomitant steroid treatment or treated with steroids in the last 4 weeks

Trial design

20 participants in 1 patient group

Perianal Crohn's Disease

Description:

Permacol Paste injection

Treatment:

Device: Permacol Paste