SuperSeton Pilot Studie

Pilot Study of SuperSeton Placement in Patients With Perianal Fistulas

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.

Study Overview

• Status: Completed
• Conditions: Perianal Crohn Disease; Perianal Fistula
• Intervention / Treatment: Device: SuperSeton

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SuperSeton arm	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seton failure	Loosening of the seton	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perianal Disease Activity Index score	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.	3 months
Procedure time		3 months
Number of participants experiencing complications	Number of participants experiencing peri-operative complications, an increase in perianal pain complains, and perianal abscesses.	3 months
Number of participants requiring surgical re-interventions		3 months

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Delft University of Technology; Proctos Kliniek; MediShield B.V.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2016
• Primary Completion (Actual): July 4, 2018
• Study Completion (Actual): July 4, 2018

Study Registration Dates

• First Submitted: August 15, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Quality of life; Knotless seton; Perianal Disease Activity Index
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Pathological Conditions, Anatomical; Inflammatory Bowel Diseases; Fistula; Crohn Disease
• Other Study ID Numbers: 2016_018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No