NL-OMON56038已完成不适用
Controlling Faecal incontinence with a novel anal device: a cost-effectiveness trial. (CONFIDEnCE) - CONFIDEnCE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 16 至 99（—）
入选标准
- •- Patients with FI according to Rome IV criteria (i.e. recurrent uncontrolled
- •passage of faecal matter for at least 3 months)
- •- Aged between 16-90 years
- •- Patients who experience at least 1 episode of accidental bowel leakage during
- •the 2 week run-in period will be eligible for randomisation.
排除标准
- •- Insufficient cognitive skills to fill in patient-reported questionnaires,
- •inability to present to hospital for screening visit and inclusion,
- •neurological/psychiatric or physical inability to comply with the study
- •protocol (including diary assessments) at the investigator*s discretion, or
- •insufficient command of the Dutch language.
- •- Anatomic abnormalities: known communication between the anal and vaginal
- •tracts, prior diagnosis of congenital anorectal malformations, previous rectal
- •surgery, radiotherapy to a pelvic organ (uterus, prostate, rectum).
- •- Prior diagnosis of inflammatory bowel disease.
- •- Pregnancy or intention to become pregnant during the study period.
研究者
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