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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 Gatekeeperâ„¢ 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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gatekeeper | Device | Six polyacrylonitrile prostheses (THD Gatekeeperâ„¢ 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients' selection was based on clinical history, physical examination, preoperative 3D-endoanal ultrasound (EUS) and a continence diary recorded for 21 days. Patients with previous history of chronic diarrhoea were evaluated by the gastroenterology team and if needed, fibre supplementation or other medical treatment was used to obtain a Bristol score of 3-4 before entering the study
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Measurement of differences in anal testing pressures using a four-channel manometer |
| baseline and three months after surgery |