Impact of Bariatric Surgery in Patients With Morbid Obesity. Prospective Study With Comparison Before and After
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Prevalence of anal incontinence before and after bariatric surgery (%)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI>40 kg/m2
- •BMI> 35 kg/m2 with comorbidity ( high blood pressure, diabetes, dyslipidemia, sleep apnea syndrome)
排除标准
- •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)
结局指标
主要结局
Prevalence of anal incontinence before and after bariatric surgery (%)
时间窗: at 6 month postoperatively
PFDI-20 score (pelvic floor distress inventory) from zero to 12 (0: no incontinence and 12: severe incontinence)
次要结局
- Severity of anal incontinence before and after surgery (score)(at 6 month postoperatively)
- quality of life related to anal incontinence (score)(at 6 month postoperatively)
- Pelvic imaging (MRI)(before and at 6 month postoperatively)
研究者
Laurent BRUNAUD
Principal investigator, Professor of Surgery
Central Hospital, Nancy, France