Impact of Bariatric Surgery in Patients With Morbid Obesity

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04009356
Study type	Observational
Source	Central Hospital, Nancy, France
Contact
Status	Completed
Phase
Start date	January 22, 2020
Completion date	January 1, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Impact of Bariatric Surgery in Patients With Morbid Obesity — IVBIA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms