Obstetric Fecal Incontinence Treatment Registry

NCT04727463 | Completed DMC

• 1 other identifier: 17/100-E
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

• Cleveland Clinic Incontinence Score

  Retrospective cohort Study

  Up to 5 years

Interventions

Sphincteroplasty PROCEDURE

Overlapping sphincteroplasty

Eligibility Criteria

• Age: 16 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

113 women (94.2%) and 7 men (5.8%), aged between 16 and 84 years old.

You may qualify if:

• 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.

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

Study Sites (1)

Carlos Cerdán

Madrid, Spain

Location

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Sphincterotomy, Transduodenal

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Sphincterotomy; Myotomy

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: January 27, 2021
• Study Start: December 16, 2020
• Primary Completion: December 16, 2020
• Study Completion: December 16, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)