Fecal Incontinence and Rectal Static Disorder

Fecal Continence Disorders Clinical Trial

— NATUROSTATIQ  

Official title:

Evolution of Fecal Incontinence in Patients With Rectal Static Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04566640
• Other study ID #: 35RC20_3074_NATUROSTATIQ
• Status: Recruiting
• Start date: May 15, 2021
• Est. completion date: January 15, 2024

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: Marion Chambaz
• Phone: 02 99 28 43 11
• Email: marion.chambaz[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Fecal Continence Disorders
• Fecal Incontinence
• Posterior Pelvic Static Disorders

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal incontinence defined by a Cleveland score > 5	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.	6 weeks
Secondary	natural history of constipation symptoms in patients with posterior pelvic static disorders	Evaluation of Constipation Symptoms (Kess Score),	6 weeks
Secondary	quality of life in patients with posterior pelvic static disorders	Quality of Life Score (Score SF36)	6 weeks