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OpenTrials
Completed

NCT Number: NCT04009356

Impact of Bariatric Surgery in Patients With Morbid Obesity

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.

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Key information

Conditions

Obesity, Morbid Anal Incontinence Behavior Behavioral Symptoms Body Weight Elimination Disorders Encopresis Image, Body Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Nancy, 54511, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

bariatric surgical procedures

Procedure

gastric bypass, sleeve, banding,biliopancreatic diversion

Primary outcomes

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

    Time frame: at 6 month postoperatively

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

Secondary outcomes

  1. Severity of anal incontinence before and after surgery (score)

    Time frame: at 6 month postoperatively

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

  2. quality of life related to anal incontinence (score)

    Time frame: at 6 month postoperatively

    PFIQ-7 (pelvic floor impact questionnaire) from 0 to 16 (0: no incontinence and 16: severe incontinence)

  3. Pelvic imaging (MRI)

    Time frame: before and at 6 month postoperatively

    MRI

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: IVBIA

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 5, 2019
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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