NCT04009356

Brief Summary

The main objective is to compare the prevalence of anal incontinence (AI) before and after bariatric surgery in obese patients. Inclusion: Patients who are scheduled for a bariatric surgical procedure after a multidisciplinary evaluation for about 1 year (following french national recommendations). Primary objective: After inclusion, all patients will fill in a specific self-questionnaire evaluating AI (PFDI-20 score) before surgery and at 6 months after surgery. Investigators will evaluate the prevalence of anal incontinence before and at 6months after surgery using this PFDI- 20 score. In those patients with preoperative anal incontinence (only in patients with 3 positive answers to question n°9,10, and 11 of PFDI-20 score self-questionnaire), a pelvic MRI will be performed before and at 6 months after surgery. Consequently, no further imaging exam will be performed in patients without preoperative anal incontinence (less than 3 positive answers to question n°9,10, and 11), Secondary objectives:

  • to evaluate the AI severity variation before and at 6 months after bariatric surgery regarding the percentage of postoperative weight loss.
  • to compare the quality of life (PFIQ-7 score) related to AI day before and at 6 months after bariatric surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

January 22, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

June 20, 2019

Last Update Submit

March 8, 2022

Conditions

Obesity, MorbidAnal IncontinenceImage, Body

Outcome Measures

Primary Outcomes (1)

  • Prevalence of anal incontinence before and after bariatric surgery (%)

    PFDI-20 score (pelvic floor distress inventory) from zero to 12 (0: no incontinence and 12: severe incontinence)

    at 6 month postoperatively

Secondary Outcomes (3)

  • Severity of anal incontinence before and after surgery (score)

    at 6 month postoperatively

  • quality of life related to anal incontinence (score)

    at 6 month postoperatively

  • Pelvic imaging (MRI)

    before and at 6 month postoperatively

Interventions

bariatric surgical proceduresPROCEDURE

gastric bypass, sleeve, banding,biliopancreatic diversion

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are scheduled for a bariatric surgical procedure after a multidisciplinary evaluation for about 1 year (following HAS national recommendations).

You may qualify if:

  • BMI\>40 kg/m2
  • BMI\> 35 kg/m2 with comorbidity ( high blood pressure, diabetes, dyslipidemia, sleep apnea syndrome)

You may not qualify if:

  • anal incontinence due to chronic diarrhea
  • transit constipation
  • peripheral neuropathy (diabetes ...)
  • patient opposition
  • any previous bariatric surgical procedure
  • any pelvic surgical procedure performed during the study period (between preoperative and postoperative period at 6 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nancy, 54511, France

Location

MeSH Terms

Conditions

Obesity, MorbidEncopresis

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Professor of Surgery

Study Record Dates

First Submitted

June 20, 2019

First Posted

July 5, 2019

Study Start

January 22, 2020

Primary Completion

August 1, 2021

Study Completion

January 1, 2022

Last Updated

March 9, 2022

Record last verified: 2022-03

Locations

FR(1)