Gatekeeper™ Prostheses Implants for Patients With Gas Incontinence and Soiling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 主要终点
- Patient's Subjective Perception
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients older than 18 years old
- •with at least 6 months of GI and/or soiling
- •non-responding to conservative treatment and biofeedback.
排除标准
- •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.
结局指标
主要结局
Patient's Subjective Perception
时间窗: 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"
Change in the number of gas incontinence and soiling episodes
时间窗: 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
时间窗: 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"
次要结局
- Differences in anal pressures(baseline and three months after surgery)
- Changes in prostheses location(baseline and one month after surgery)
研究者
Arantxa Muñoz-Duyos
Clinical Chief of General and Digestive Surgery
Hospital Mutua de Terrassa