Surgical closure versus anti-TNF in the treatment of perianal fistulas in Crohn’s Disease (PISA-II): a comprehensive cohort desig

Completed

Conditions: Perianal Crohn's fistulas

Registration Number: NL-OMON20965

Lead Sponsor: Crohns and Colitis Foundation and ZonMw

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 116

Inclusion Criteria

= 18 years
-Active perianal fistula
- High perianal fistula tract (intersphincteric, transsphincteric, suprasphincteric) located in the upper two-thirds of the external sphincter or puborectal muscle.
-Fistula with one internal opening (based on MRI imaging). The number of external fistulas does not have to be taken into account.
-Written informed consent

Exclusion Criteria

- Proctitis (defined as any active mucosal inflammation or ulcer > 5mm in the rectum)
- Anorectal stenosis (defined as the impossibility to introduce a proctoscope)
- Submucosal fistulas & low intersphincteric fistulas (lower one-third of external sphincter)
- Rectovaginal fistula
- Multiple internal openings
-Previous failure of anti-TNF treatment for perianal fistula
- Patients with a stoma
- Dementia or altered mental status that would prohibit the understanding and giving of informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of this study is to the number of patients with radiologically closed perianal fistulas (on MRI) after 18 months. A radiologists blinded to treatment allocation will determine whether the fistula is completely fibrotic on MRI and/or will use a validated score, e.g. the van Assche score. The comparison between the anti-TNF and surgical closure arm will be assessed using Chi-square test.

Secondary Outcome Measures

Name	Time	Method
The secondary outcomes parameters are clinical closure, defined as closure of the external opening without discharge of pus or faeces on palpation, number of patients undergoing surgical re-interventions and amount of re-interventions due to fistula related complications, fistula recurrence, defined as re-opening of the external opening after clinical closure, and quality of life as assessed by the PDAI.