Clinical trial NCT04566640: Fecal Incontinence and Rectal Static Disorder
Official title: Evolution of Fecal Incontinence in Patients With Rectal Static Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fecal Continence Disorders
Posterior Pelvic Static Disorders
Keywords: Fecal incontinence
pelvic static disorders
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having a posterior pelvic static disorder diagnosed and having benefited from a functional review in proctology between 2005 and 2019 in the proctology department of the University Hospital of Rennes

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fecal incontinence defined by a Cleveland score > 5
timeFrame: 6 weeks
Secondary outcomes:
measure: natural history of constipation symptoms in patients with posterior pelvic static disorders
timeFrame: 6 weeks
measure: quality of life in patients with posterior pelvic static disorders
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
References: