Fecal Incontinence and Rectal Static Disorder (NATUROSTATIQ)

Rennes University Hospital

Status: Enrolling

Conditions: Fecal Continence Disorders; Posterior Pelvic Static Disorders

Study type: Observational

Funder types: Other

Identifiers

NCT04566640

35RC20_3074_NATUROSTATIQ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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