Gatekeeper for Soiling and Gas Incontinence

Hospital Mutua de Terrassa

Status: Completed

Conditions: Gas Incontinence; Soilings, Fecal

Treatments: Device: Gatekeeper

Study type: Observational

Funder types: Other

Identifiers

NCT05222217

P21/0001

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.