Clinical trial NCT04009356: Impact of Bariatric Surgery in Patients With Morbid Obesity
Official title: Impact of Bariatric Surgery in Patients With Morbid Obesity. Prospective Study With Comparison Before and After
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Anal Incontinence
Image, Body
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Prevalence of anal incontinence before and after bariatric surgery (%)
timeFrame: at 6 month postoperatively
Secondary outcomes:
measure: Severity of anal incontinence before and after surgery (score)
timeFrame: at 6 month postoperatively
measure: quality of life related to anal incontinence (score)
timeFrame: at 6 month postoperatively
measure: Pelvic imaging (MRI)
timeFrame: before and at 6 month postoperatively
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy - Département Chirurgie Viscérale, Métabolique et Cancérologique CVMC (7ème étage)
Study officials:
References: