跳至主要内容
临床试验/NCT04727463
NCT04727463已完成不适用

Obstetric Fecal Incontinence Treatment Registry

Hospital San Carlos, Madrid1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年12月16日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Cerdán Santacruz

Principal Investigator

Hospital San Carlos, Madrid

研究点 (1)

Loading locations...

相似试验