Feasibility study of Smooth Seton placement in patients with perianal fistulas

Feasibility study of Smooth Seton placement in patients with perianal fistulas - Smooth Seton feasibility studie

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42252

Enrollment

Registered

2015-07-02

Start date

2015-07-20

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

perianal fistula

Interventions

The Smooth Seton will be placed at the outpatient clinic in patients with already a seton in situ. This seton will then be exchanged by the Smooth Seoton.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients >= 18 years - Written informed consent - Perianal fistulas (for which a seton was placed that is still in situ)

Exclusion criteria

Exclusion criteria: - Patients with a pacemaker or an ICD in situ - Patients participating in a different trial - Rectovaginal fistula - Patients with a stoma - Life expectancy

Design outcomes

Primary

Measure	Time frame
The primary outcome is seton failure (loosening of the seal)	—

Secondary

Measure	Time frame
Secondary outcomes are time of procedure, complications and quality of life measured by the the PDAI (Perianal Disease Activity Index).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)