Fecal Incontinence and Rectal Static Disorder

Recruiting

• Conditions: Fecal Continence Disorders; Posterior Pelvic Static Disorders

• Registration Number: NCT04566640
• Lead Sponsor: Rennes University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-28
• Study Start: 2021-05-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-03
• Primary Completion: 2024-01-15
• Study Completion: 2024-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patient over 18 years of age

• Having a disorder of posterior pelvic statics

• Diagnosed during the period 2005 - 2019

• Having a functional assessment in proctology between 2005 and 2019 in the proctology department of the Rennes University Hospital Center (CHU)

• This complete functional assessment was carried out in consultation with proctology, as part of routine care, and included :

  • Data from the interrogation
  • Reported symptoms: incontinence, constipation and quality of life (collected through questioning and through a questionnaire systematically completed by the patient during the routine care consultation),
  • A clinical examination
  • Anorectal manometry
  • A defecography

• no one who does not object to participation in the research

Exclusion Criteria

• persons of full age subject to legal protection (safeguard of justice, guardianship, trusteeship), persons deprived of liberty

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fecal incontinence defined by a Cleveland score > 5	6 weeks	The objective of the study is to compare the rate of occurrence of fecal incontinence in patients who have had surgery for a disorder of posterior pelvic statics versus those with medical management.

Secondary Outcome Measures

Name	Time	Method
natural history of constipation symptoms in patients with posterior pelvic static disorders	6 weeks	Evaluation of Constipation Symptoms (Kess Score),
quality of life in patients with posterior pelvic static disorders	6 weeks	Quality of Life Score (Score SF36)

Trial Locations

Locations (1)

Rennes University Hospital; 🇫🇷 Rennes, France