Gatekeeper for Soiling and Gas Incontinence

Hospital Mutua de Terrassa13 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Gas Incontinence Soilings, Fecal

Interventions

GatekeeperDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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"

Time frame: 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"

Time frame: 6, 12 and 24 months after surgery

Secondary Outcomes

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.

Time frame: baseline and one month after surgery

Differences in anal pressures

Measurement of differences in anal testing pressures using a four-channel manometer

Time frame: baseline and three months after surgery