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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20965

Enrollment

116

Registered

2019-03-27

Start date

2013-09-01

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Perianal Crohn's fistulas

Interventions

The following groups will be compared: Group I: Seton placement, followed by anti-TNF medication in combination with a immunomodulator after ± 2 weeks. The seton will be removed after ± 6 weeks. Conti

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Contacts

Public ContactKarin Wasmann

Amsterdam University Medical Center, location Academic Medical Center (AMC)

k.a.wasmann@amc.nl003120-5662870

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)