Gas Incontinence, Soilings, Fecal
Conditions
Brief summary
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
Interventions
DEVICEGatekeeper
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.
Sponsors
Hospital Mutua de Terrassa
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the number of gas incontinence and soiling episodes | 6, 12 and 24 months after surgery | Each patient completes a three-week continence diary specifically recording gas incontinence and soiling episodes at baseline and before every follow-up visit. |
| Changes in incontinence symptoms | 6, 12 and 24 months after surgery | 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 |
| Patient's Subjective Perception | 6, 12 and 24 months after surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in prostheses location | baseline and one month after surgery | Prostheses migration was defined as displacement of the prosthesis to the suprasphincteric space detected during the follow-up, detected with 3D-Endoanal Ultrasound. |
| Differences in anal pressures | baseline and three months after surgery | Measurement of differences in anal testing pressures using a four-channel manometer |
Outcome results
None listed