fistulous
Conditions
Interventions
Patients with a perianal abscess/sinus or (Crohn*s) perianal fistula will be
included in the study. This study will evaluate two groups of patients. The
first group will consist of patients presenti
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Perianal abscesses/ sinuses or (Crohn*s) perianal fistula - >= 18 years and
Exclusion criteria
Exclusion criteria: - Patients with more than 2 external perianal openings - Rectovaginal fistula - Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the first part of the pilot study is to determine if the Semiflex Dome Catheter System meets the proof of principle with respect to: a. Smoothness of insertion and changing the semiflex catheters • Is it feasible to insert the catheter? • How painful is the changing of the catheters based on the Visual Analoge Score (VAS)? A VAS >5 is considered too painful. b. Capability of proper fixation of the catheter • Will the catheter be fixed during the study period? c. Capability of maintaining vacuum for more than 48 hours • Will the vacuum be maintained for more than 48 hours? d. Compliance to the therapy in terms of pain and discomfort • How uncomfortable/ painful is the catheter for the patient based on the VAS? A VAS >5 is considered too painful. The proof of principle will be met when 50% of the participants per study group meet all the primary objectives, so point A,B,C and D. These points will be scored individually and only if one individual meets all of the points, the participant will be scored as successful. If 50% or more of the participants per study group are successful, the proof of principle in that corresponding study group is met. This correspondence with a minimum of 5 participants per study group. When the fistula group and/ or the perianal abscess/sinus group meets the proof of principle, the second part of the pilot study will start. A percentage of 50% has been chosen, so the procedure can be optimized at the Amsterdam UMC, taking a learning curve into account. The primary objective of the second part of the pilot study is to determine feasibility of the Semiflex Dome Catheter System with respect to: a. Smoothness of insertion and changing the semiflex catheters • Is it feasible to insert the catheter? • How painful is the changing of the catheters based on the Visual Analoge Score (VAS)? A VAS >5 is considered too painful. b. Capability of proper fixation of the catheter • Will the catheter be | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives of this study are: a. Efficacy of drainage of perianal abscess/sinus (e.g. absence of retention) b. Efficacy of curing the perianal abscess/sinus in terms of complete collapse of the sinus and disappearance of induration c. Efficacy of management of perianal fistula in terms of healing after successive exchanges (first placement is in combination with closure of the internal opening) d. Radiological healing defined as complete fibrosis on magnetic resonance imaging (MRI) e. Safety of the Semiflex Dome Catheter System in terms of complications which may occur during treatment | — |
Countries
Netherlands
Outcome results
None listed