Pilot Study of SuperSeton Placement in Patients with Perianal Fistulas

Pilot Study of SuperSeton Placement in Patients with Perianal Fistulas - SuperSeton Pilot Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45970

Enrollment

Registered

2016-07-27

Start date

2016-08-10

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 SuperSeton will be placed at the outpatient clinic in patients that already have a seton in situ. This seton will then be exchanged by the SuperSeton. In case patient do not have a seton in situ

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients of 18 years or older - Written informed consent - Perianal fistulas for which a seton was placed that is still in situ or recurrent perianal fistulas (ever treated with a knotted seton) for which a new seton will be placed

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main study parameters/endpoints: The primary outcome is seton failure (loosening of the seton).	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)