Obstetric Fecal Incontinence Treatment Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Cleveland Clinic Incontinence Score
研究概览
简要总结
INTRODUCTION Anal Incontinence (AI) is a loose of voluntary control for bowel movements, with recurrent leaking of flatus, liquid or solid stools.
AI is a frecuent pathology. Prevalence is similar among men and women. AI´s ethiology is quite variable. Nevertheless, the most frecuent one is sphinteric injuries, obstetric, traumatic or secondary to anal surgery.
Conservative measures have to be iniciated and they are essential for every patient.
If a sphincteric injury exists, several choices of surgical treatment exist. The long term results obtained with sphincteroplasty, with a uniform surgical technique, follow up and complementing with other therapeutic options, has been considered interesting to analyze.
HYPOTHESIS Sphincteroplasty with the adoption of the appropriate complementary treatments, provides satisfactory results in the very long term, and should be considered as the procedure of choice in patients with Anal Incontinence.
OBJECTIVES
- Analyze the very long term results obtained with Sphincteroplasty as surgical technique for treatment of severe anal incontinence.
- Evaluate the results of the different types of surgical repair performed, according to the CCIS Score (Wexner Score).
- Evaluate the importance of patient follow-up and incorporation of complementary treatments.
- Establish patient´s satisfaction with the procedure after a long term follow up period after the intervention.
详细描述
MATERIAL AND METHODS
PATIENTS AND METHOD A retrospective Cohort study was designed, based on a prospectively maintained database, including every consecutive patient operated on severe AI secondary to sphincteric injury with sphincterolplasty, between January 1985 and December 2013.
Every operations were performed by the same surgeon in two centers, Hospital Clinico San Carlos and Santa Elena Clinic, both in Madrid.
INCLUSION CRITERIA Every patients, without limitation of gender or age, with any kind of sphincteric lesion susceptible of surgical repair, presenting with AI and severe impairment in quality of life, after following a conservative treatment and unsatisfactory results.
EXCLUSION CRITERIA There are not exclusion criteria except non-fitting inclusion criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 16 Years 至 84 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any person with kind of sphincteric lesion susceptible of surgical repair.
- •Presenting with Anal Incontinence and severe impairment in quality of life.
- •Unsatisfactory results after following a conservative treatment.
排除标准
- •Not exclusion criteria except non-fitting inclusion criteria.
结局指标
主要结局
Cleveland Clinic Incontinence Score
时间窗: Up to 5 years
Retrospective cohort Study
次要结局
未报告次要终点
研究者
Carlos Cerdán Santacruz
Principal Investigator
Hospital San Carlos, Madrid
