Impact of Bariatric Surgery in Patients With Morbid Obesity

NCT ID: NCT04009356

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-22
• Study Completion Date: 2022-01-01

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.

Conditions

Obesity, Morbid; Anal Incontinence; Image, Body

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

bariatric surgical procedures

gastric bypass, sleeve, banding,biliopancreatic diversion

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Laurent BRUNAUD

Principal investigator, Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Nancy, , France

Countries

France

Other Identifiers

ID-RCB:2019-A01229-48

Identifier Type: -

Identifier Source: org_study_id