SuperSeton Pilot Studie

Summary

Rationale: 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.

Objective: The aim of this study is to determine the feasibility of SuperSeton placement in patients with perianal fistulas.

Study design: The design of the study is a feasibility study.

Study population: Patients (≥ 18 years) with perianal fistulas (ever) treated with a knotted seton are eligible.

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 patients 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.

Main study parameters/endpoints: The primary outcome is seton failure (loosening of the seton). Secondary outcomes are time of procedure, complications and quality of life measured by the PDAI ('Perianal Disease Activity Index').

Nature and extent of the burden and risks associated with participation: The SuperSeton will be placed in patients with perianal fistulas (ever) treated with a conventional knotted seton. 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, this 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). Sample size calculation: A group of 60 patients will be included to determine feasibility of the SuperSeton. The proposed treatment protocol is considered feasible if at least 70% of the SuperSetons stay in place.

Conditions

• Perianal Fistula
• Perianal Crohn Disease

Interventions

DEVICE

SuperSeton

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 patients 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.

Sponsors & Collaborators

• Proctos Kliniek

  collaborator OTHER

• MediShield B.V.

  collaborator UNKNOWN

• Delft University of Technology

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-10

Primary Completion

2018-07-04

Completion

2018-07-04