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Completed

NCT Number: NCT03654482

SuperSeton Pilot Studie

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.

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Key information

Conditions

Perianal Fistula Perianal Crohn Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years
  • Written informed consent
  • Perianal fistula with a seton in situ or a recurrent perianal fistula 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

Treatment and study plan

SuperSeton

Device

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.

Primary outcomes

  1. Seton failure

    Time frame: 3 months

    Loosening of the seton

Secondary outcomes

  1. Perianal Disease Activity Index score

    Time frame: 3 months

    The PDAI is the gold standard for evaluating the severity of perianal disease. It includes five items: discharge, pain, restriction of sexual activity, type of perianal disease, and degree of induration. Each category is graded on a five-point Likert scale ranging from no symptoms to severe symptoms. The sum of the five subscores represents the total PDAI score.

  2. Procedure time

    Time frame: 3 months

  3. Number of participants experiencing complications

    Time frame: 3 months

    Number of participants experiencing peri-operative complications, an increase in perianal pain complains, and perianal abscesses.

  4. Number of participants requiring surgical re-interventions

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Delft University of Technology
  • MediShield B.V.
  • Proctos Kliniek

Registry information

Official study title

Pilot Study of SuperSeton Placement in Patients With Perianal Fistulas

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 31, 2018
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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