Evolution of Fecal Incontinence in Patients With Rectal Static Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Fecal incontinence defined by a Cleveland score > 5
研究概览
简要总结
This study evaluate the rate of occurrence of fecal incontinence in patients who had surgery for posterior pelvic static disorder versus those with medical management.
The aim is also to assess the natural history of constipation symptoms and quality of life in patients with posterior pelvic static disorder.
详细描述
Data of all patients with posterior pelvic static disorder are collected prospectively and consecutively in the Fondamentum database since 2005, secured and hosted by the Rennes University Hospital.
The data from initial functional assessment, carried out as part of routine care between 2005 and 2019, include a clinical examination of pelvic static disorders, anorectal manometry, defecography, collection of symptoms by questioning and by a systematic questionnaire completed by the patient during the routine care consultation.
Patients identified from this database and meeting the selection criteria will receive an information letter along with a questionnaire and a stamped envelope for returning the questionnaire. The self-questionnaires will focus on collecting symptoms related to static disorders (incontinence, constipation, quality of life). Regarding the management of pelvic static disorder, we will detail whether it was operated or not, and what were the proposed medical care.
Upon receipt of the questionnaire, the new data will be entered into the research-specific database and will complete the clinical data resulting from the extraction of the care base The self-administered questionnaire sent to patients includes validated constipation (score of kess) and fecal incontinence (Cleveland) questionnaires, and quality of life questions from the validated SF36 questionnaire. It also includes a visual scale ranging from -5 to +5.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years of age
- •Having a disorder of posterior pelvic statics
- •Diagnosed during the period 2005 - 2019
- •Having a functional assessment in proctology between 2005 and 2019 in the proctology department of the Rennes University Hospital Center (CHU)
- •This complete functional assessment was carried out in consultation with proctology, as part of routine care, and included :
- •Data from the interrogation
- •Reported symptoms: incontinence, constipation and quality of life (collected through questioning and through a questionnaire systematically completed by the patient during the routine care consultation),
- •A clinical examination
- •Anorectal manometry
- •A defecography
- •no one who does not object to participation in the research
排除标准
- •persons of full age subject to legal protection (safeguard of justice, guardianship, trusteeship), persons deprived of liberty
结局指标
主要结局
Fecal incontinence defined by a Cleveland score > 5
时间窗: 6 weeks
The objective of the study is to compare the rate of occurrence of fecal incontinence in patients who have had surgery for a disorder of posterior pelvic statics versus those with medical management.
次要结局
- natural history of constipation symptoms in patients with posterior pelvic static disorders(6 weeks)
- quality of life in patients with posterior pelvic static disorders(6 weeks)