Impact of Bariatric Surgery in Patients With Morbid Obesity (IVBIA)

Impact of Bariatric Surgery in Patients With Morbid Obesity. Prospective Study With Comparison Before and After

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid; Anal Incontinence; Image, Body
• Intervention / Treatment: Procedure: bariatric surgical procedures

Detailed Description

This study is proposed to all obese patients evaluated for potential bariatric surgery during a multidisciplinary evaluation for about 1 year following current french national recommendations.

Demographics are collected from medical records (age, sex, weight, height, diabetes, sleep apnea syndrome, hypertension, lipid disorders, distal neuropathy, depression, number of pregnancies, history of vaginal delivery, traumatic delivery, caesarean section, hysterectomy, urinary incontinence surgery, proctologic surgery, presence of rectal prolapse (operated or not), cholecystectomy, digestive resection, menopause, history of urinary or fecal or gaseous leakage, current treatments, tobacco consumption, diet.

Data are collected by self-questionnaire to all included patient during the preoperative consultation (about 6 weeks before bariatric surgery) and during the 6-months postoperative clinical visit scheduled during the regular follow-up.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54511
    • CHRU Nancy - Département Chirurgie Viscérale, Métabolique et Cancérologique CVMC (7ème étage)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of anal incontinence before and after surgery (score)	PFDI-20 score (pelvic floor distress inventory) from zero to 12 (0: no incontinence and 12: severe incontinence)	at 6 month postoperatively
quality of life related to anal incontinence (score)	PFIQ-7 (pelvic floor impact questionnaire) from 0 to 16 (0: no incontinence and 16: severe incontinence)	at 6 month postoperatively
Pelvic imaging (MRI)	MRI	before and at 6 month postoperatively

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2020
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: June 20, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Intestinal Diseases; Rectal Diseases; Obesity; Obesity, Morbid; Fecal Incontinence
• Other Study ID Numbers: ID-RCB:2019-A01229-48

Drug and device information, study documents

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