With this study we aim to determine the feasibility of SuperSeton placement in patients with perianal fistulas.
ID
Source
Brief title
Condition
- Anal and rectal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: The primary outcome is seton failure
(loosening of the seton).
Secondary outcome
Secondary outcomes are time of procedure, complications and quality of life
measured by the PDAI (*Perianal Disease Activity Index*).
Background summary
Perianal fistulas are a common incapacitating problem. Many patients are
treated by seton drainage to prevent recurrent abscess formation. Nowadays,
vessel loops or sutures are used for drainage. The knot of these seton drains
can cause complaints of pain or tenderness if it presses against the external
opening of the fistula or even slides in to the fistula tract. Medishield B.V.
designed a knotless seton drain, the SuperSeton. This could decrease the pain
complaints caused by the knot.
Study objective
With this study we aim to determine the feasibility of SuperSeton placement in
patients with perianal fistulas.
Study design
The design of the study is a feasibility study.
Intervention
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, the SuperSeton can be placed at the
operating theatre in day care setting instead of a regular seton.
Study burden and risks
The SuperSeton will be placed in patients with perianal fistulas (with or
without a seton in situ). There are no additional risks involved. The seton
will be placed at the outpatient clinic in patients with a seton in situ, or at
the operating theatre in day care setting in patients with a perianal abscess
without a seton. The material that is used for the Setons is of medical grade
polyurethane, is the same material of catheters that are already used in
clinical practice (instech BTPU 027). The Setons including the insert (BTPU)
are supplied sterile (Synergy Health).
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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
- Patients with a pacemaker or an ICD in situ
- Rectovaginal fistula
- Patients with a stoma
- Life expectancy < 2 years
- The inability of reading/understanding and filling in the questionnaires
- Dementia or altered mental status that would prohibit the understanding and giving of informed
Consent
- Participation in another trial
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56590.018.16 |