SphinkeeperTM Procedure for Treating Severe Faecal Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Faecal incontinence assessment
研究概览
简要总结
Patients, aged 18 - 90 years, undergoing sphinkeeper operation at the Department of General Surgery at the Medical University of Vienna are enrolled into our study. Primary endpoints is the functional outcome as well as movement, migration and extrusion of sphinkeeper prostheses after implantation by endoluminal ultrasound and manometrical examination.
详细描述
The Sphinkeeper™ implantation for fecal incontinence is a novel surgical procedure with limited data on its clinical efficacy. Therefore, we aimed to assess the functional outcome following Sphinkeeper™ surgery in patients with refractory FI.
Patients with FI, who met the inclusion criteria were enrolled to our study and received Sphinkeeper™ implantation. Functional outcome and quality of life was evaluated by standard questionnaires before and after surgery. In the routine check-up patients received endoanal ultrasound and anorectal manometry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 90 years, undergoing sphinkeeper operation at the Department of General Surgery, Medical University of Vienna
- •Ability and willingness to understand and comply with study interventions and restrictions.
- •Voluntarily signed informed consent after full explanation of the study to the participant.
排除标准
- •Any physical or mental disorder, which could interfere with the participant's safety during the clinical trial or with the study objectives
- •Inability to communicate well with the investigator due to language problems or reduced mental development
- •Inability or unwillingness to give written informed consent
结局指标
主要结局
Faecal incontinence assessment
时间窗: six months
Episodes and number of faecal incomtinence and stool form with faecal incontinence were assessed using the Vaizey incontinence score (range 0-22, higher numbers mean severe incontinence forms)
次要结局
- Migration of Sphinkeeper prostheses(six months)
- Psychological und physical well-being(six months)
研究者
Dr. Christopher Dawoud
Dr.med.univ., Research Fellow
Medical University of Vienna