NCT04566640

Fecal Incontinence and Rectal Static Disorder

Evolution of Fecal Incontinence in Patients With Rectal Static Disorder

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Fecal Continence Disorders
• Posterior Pelvic Static Disorders

Timeline

• Start date: 2021-05-15
• Primary completion: 2024-01-15
• Completion: 2024-01-15
• First posted: 2020-09-28
• Last updated: 2023-05-03

Locations

1 site across 1 country: France