Gatekeeper for Soiling and Gas Incontinence

Study Overview
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Brief Summary
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Faecal incontinence has a broad spectrum of symptoms. Some patients only suffer commonly considered mild symptoms: gas incontinence and soiling, but patients' quality of life is significantly impaired. Although several treatments for faecal incontinence are available, this subgroup of patients are difficult to treat, and no therapeutic alternative has been clearly defined. The aim of this study is to evaluate Gatekeeper™ treatment for this subgroup of patients with faecal incontinence, not studied before. Consecutive case series single-centre study. Patients with mainly soiling and/or gas incontinence were treated with polyacrylonitrile prostheses

Official Title
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Gatekeeper™ Prostheses Implants for Patients With Gas Incontinence and Soiling

Conditions
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Gas Incontinence, Soilings, Fecal

Intervention / Treatment
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* Device: Gatekeeper


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients older than 18 years old with at least 6 months of GI and/or soiling non-responding to conservative treatment and biofeedback. Exclusion Criteria: complete solid and liquid FI common Bristol score > 4 malignant diseases chronic diarrhoea inflammatory bowel disease acute anorectal disease rectal prolapse neurological disease, obstructive defecation syndrome low anterior resection syndrome, previous pelvic radiation, any anaesthetic contraindication St. Mark's score > 12 external anal sphincter lesion > 30º.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Gatekeeper|Six polyacrylonitrile prostheses (THD Gatekeeper™ Delivery System, THD SpA, Correggio, Italy) were implanted under 3D-EUS control through a 5mm perianal incision at 1, 3, 5, 7, 9 and 11 o'clock in lithotomy position, and located in the upper-middle intersphincteric space of the anal canal, using a specifically designed system.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of gas incontinence and soiling episodes | Each patient completes a three-week continence diary specifically recording gas incontinence and soiling episodes at baseline and before every follow-up visit. | 6, 12 and 24 months after surgery | 
| Changes in incontinence symptoms | Evaluation of incontinence symptoms with the St. Mark's Incontinence Score. Score from 0 to 24, where 0 means complete continence and 24 means severe fecal incontinence | 6, 12 and 24 months after surgery | 
| Patient's Subjective Perception | Changes in patient subjective evaluation using a Visual Analogue Scale (VAS). Score from 0 to 10, where 0 means no problem and 10 means severe problem and alteration of my quality of life | 6, 12 and 24 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in prostheses location | Prostheses migration was defined as displacement of the prosthesis to the suprasphincteric space detected during the follow-up, detected with 3D-Endoanal Ultrasound. | baseline and one month after surgery | 
| Differences in anal pressures | Measurement of differences in anal testing pressures using a four-channel manometer | baseline and three months after surgery |