Fecal Incontinence and Rectal Static Disorder (NATUROSTATIQ)

Evolution of Fecal Incontinence in Patients With Rectal Static Disorder

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.

Study Overview

• Status: Recruiting
• Conditions: Fecal Continence Disorders; Posterior Pelvic Static Disorders

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Marion Chambaz; Phone Number: 02 99 28 43 11; Email: marion.chambaz@chu-rennes.fr

Study Locations

• France
  • Rennes, France, 35000
    • Recruiting
    • Rennes University Hospital
    • Contact: Marion Chambaz; Email: marion.chambaz@chu-rennes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Anticipated): January 15, 2024
• Study Completion (Anticipated): January 15, 2024

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Fecal incontinence; pelvic static disorders
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Disease; Fecal Incontinence
• Other Study ID Numbers: 35RC20_3074_NATUROSTATIQ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No