Obstetric Fecal Incontinence Treatment Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospital San Carlos, Madrid
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Cleveland Clinic Incontinence Score
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 16 Years to 84 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Not exclusion criteria except non-fitting inclusion criteria.
Outcomes
Primary Outcomes
Cleveland Clinic Incontinence Score
Time Frame: Up to 5 years
Retrospective cohort Study
Secondary Outcomes
No secondary outcomes reported
Investigators
Carlos Cerdán Santacruz
Principal Investigator
Hospital San Carlos, Madrid