Completed

IVBIAEvaluation of Bariatric Surgery Impact on Morbidly Obese Patients: Pre and Post-Surgery Comparison

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Study Aim

This study aims to observe and compare the prevalence of anal incontinence in morbidly obese patients before and after bariatric surgery, using the PFDI-20 score as a measure of severity.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Behavior+12

+ Mental Disorders

+ Behavioral Symptoms

From 18 to 65 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: January 2020
See protocol details

Summary

Principal SponsorCentral Hospital, Nancy, France
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 22, 2020

Actual date on which the first participant was enrolled.

This study focuses on obese individuals who are considering bariatric surgery. The goal is to understand the impact of this surgery on their health, with a special focus on a condition called anal incontinence. The study follows current French national recommendations and spans about a year. It includes people with various health conditions related to obesity, such as diabetes, sleep apnea, hypertension, and depression. The study collects information from medical records and self-questionnaires. These questionnaires are filled out by the participants around 6 weeks before the surgery and again during a follow-up visit 6 months after the surgery. The main outcome of interest is the change in the prevalence of anal incontinence before and after the surgery. This is measured using a score called the PFDI-20, which ranges from zero (no incontinence) to 12 (severe incontinence).

Official TitleImpact of Bariatric Surgery in Patients With Morbid Obesity. Prospective Study With Comparison Before and After
NCT04009356
Principal SponsorCentral Hospital, Nancy, France
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersBehavioral SymptomsBody WeightEncopresisNutrition DisordersNutritional and Metabolic DiseasesObesityObesity, MorbidSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsElimination DisordersOvernutritionOverweight

Criteria

2 inclusion criteria required to participate
BMI>40 kg/m2

BMI> 35 kg/m2 with comorbidity ( high blood pressure, diabetes, dyslipidemia, sleep apnea syndrome)

6 exclusion criteria prevent from participating
anal incontinence due to chronic diarrhea

transit constipation

peripheral neuropathy (diabetes ...)

patient opposition

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

CHRU Nancy - Département Chirurgie Viscérale, Métabolique et Cancérologique CVMC (7ème étage)

Nancy, FranceOpen CHRU Nancy - Département Chirurgie Viscérale, Métabolique et Cancérologique CVMC (7ème étage) in Google Maps
CompletedOne Study Center