Ileal Interposition to the Treatment of Weight Regain After Roux-en-Y Gastric Bypass: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes of Health-related quality of life of participants after Ileal interposition surgery as reported by 36-Item Short-Form Health Survey questionnaire
研究概览
简要总结
The investigators will study the Ileal interposition to the treatment of weight regain after Roux-en-Y gastric bypass, assessing weight loss, body composition, quality of life, metabolic biomarkers, inflammatory biomarkers, and incretin hormones
详细描述
This prospective, controlled, randomized intervention study will investigate the Ileal interposition to the treatment of weight regain after Roux-en-Y gastric bypass, assessing weight loss, body composition, health-related quality of life, metabolic biomarkers, inflammatory biomarkers, and incretin hormones. The participants will also be assessed for alcohol abuse, depressive symptoms, level of physical activity, eating disorder symptoms, and dumping syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients submitted to initial laparoscopic after initial Roux-en-Y gastric bypass for at least 3 years
- •Loss of excess weight between 60 to 80%
- •Rate of weight regain ≥60%
- •Body mass index ≥ 40 kg/m2 or ≥ 35 kg/m2, with at least 2 comorbidities associated with obesity
- •Present a previous evaluation by the multidisciplinary team with a favorable opinion of the revision surgery.
排除标准
- •Active chemical dependency on alcohol and/or illicit drugs
- •Severe psychotic or depressive disorder or history of suicide attempts in the last 12 months
- •Eating behavior disorder (uncontrolled)
- •Secondary causes of obesity
- •Pregnancy
- •Severe organ failure
- •Active neoplastic
- •Infectious or inflammatory disease
- •Severe coagulopathy
- •High anesthetic-surgical risk
- •Intellectual inability
- •Lack of preoperative follow-up
研究组 & 干预措施
Traditional surgical technique
Conventional revisional surgery group Procedure/Surgery: Bariatric surgery
干预措施: Traditional surgical technique (Procedure)
Ileal Interposition
Interposition ileal surgery group Procedure/Surgery: Bariatric surgery
干预措施: Ileal Interposition (Procedure)
结局指标
主要结局
Changes of Health-related quality of life of participants after Ileal interposition surgery as reported by 36-Item Short-Form Health Survey questionnaire
时间窗: Change from Baseline and after 6 months post-surgery
Health-related quality of life will be assessed using the 36-Item Short-Form Health Survey questionnaire
Changes of weight loss of participants after Ileal interposition surgery as measured by weight in kilograms
时间窗: Change from baseline and after 6 months post-surgery
Weight loss will be obtained as the difference between preoperative weight and minimum postoperative weight in kilograms
次要结局
- Changes in alcohol abuse of participants after Ileal interposition surgery as reported by Alcohol Use Disorders Identification Test(Change from baseline and after 6 and 12 months post-surgery)
- Change of body composition of participants after Ileal interposition surgery as measured by lean and fat mass in kilograms(Change from baseline and after 6 and 12 months post-surgery)
- Change of inflammatory biomarkers and incretin hormones of participants after Ileal interposition surgery as assessed by serum levels of tumor necrosis factor-alpha, interleukin-6, ghrelin, and glucagon-like peptide-1.(Change from baseline and after 6 months post-surgery)
- Changes in the eating disorder symptoms of participants after Ileal interposition surgery as reported by the Eating Disorder Examination Questionnaire(Change from baseline and after 6 and 12 months post-surgery)
- Changes in depressive symptoms of participants after Ileal interposition surgery as reported by Beck Depression Inventory(Change from baseline and after 6 and 12 months post-surgery)
- Changes in the level of physical activity of participants after Ileal interposition surgery as reported by the International Physical Activity Questionnaire(Change from baseline and after 6 and 12 months post-surgery)
- Changes of weight loss of participants after Ileal interposition surgery as measured by weight in kilograms(Change from baseline and after 3, 6, and 12 months post-surgery)
- Change of metabolic profile of participants after Ileal interposition surgery as assessed by serum levels of glucose and insulin(Change from baseline and after 6 and 12 months post-surgery)
研究者
Luiz Guilherme Kraemer-Aguiar, MD
Principal Investigator
Rio de Janeiro State University