Fluid-filled Intragastric Balloon's Filling Volume At 500, 600, or 700 Ml for Treatment of Overweight and Obesity: Which is the Magic Number? a Single Centre Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Weight loss defined by percentage of Total Weight Loss and Excess Weight Loss
研究概览
简要总结
TITLE: Randomized study conducted in a single center, with the aim of comparing the three main filling volumes of the intragastric balloon in overweight or obese patients (BMI >27 and <60 kg/m2).
OBJECTIVE: To establish the efficacy and safety of the intragastric balloon inflated to different volumes in patients who are candidates for balloon placement for overweight or obesity. To date there is no well-defined filling volume and each Endoscopist inflates the balloon to a random volume between 500 and 700 ml according to the experience acquired, but without a clear rationale.
DESIGN: All overweight or obese patients with an indication for intragastric balloon placement will be preliminarily examined by a multidisciplinary team composed of a gastroeterologist, surgeon, nutritionist, psychologist, radiologist and endocrinologist.
Before each bariatric procedure, patients will undergo a psychometric and nutritional evaluation in order to identify any psychopathological conditions that contraindicate the operation.
The enrolled patients will be randomly divided to be candidates for balloon placement:
- 1/3 of patients will undergo treatment with an intragastric balloon inflated with 500 ml of saline solution and methylene blue, a space-occupying technique, which will be left in place for 1 year;
- 1/3 of patients will undergo treatment with an intragastric balloon inflated with 600 ml of saline solution and methylene blue;
- 1/3 of patients will undergo treatment with an intragastric balloon inflated with 700 ml of saline solution and methylene blue.
All balloons will remain in place for 6 months, as per the instructions provided in the product technical data sheet.
All the techniques described have already been widely validated by the scientific literature and are commonly used in bariatric endoscopy.
Sample size: assuming a significant level of 0.05, to detect as significant a medium effect size (f=0.25) with a power of 80% performing an ANOVA model we will need to enrol 156 patients (52 in each group). Taking into account a possible 5% of drop-out at the enrollment, the total number of patients will be around 165 (55 per group).
INFORMED CONSENT: Will be obtained upon first registration of the patient in the computer archive, as required by the hospital computer system, for access to personal data, which will be then used anonymously.
详细描述
INVESTIGATOR INITIATED STUDY A single-center, randomized study will be conducted in order to compare the three main fluid-filled intragastric balloon's (FF-IGB) filling volumes (500, 600 or 700 ml) for treatment of patients with overweight and obesity (BMI >27 and <60 kg/m2) at Gastroenterology and Gastrointestinal Endoscopy Unit, Mater Olbia Hospital, Qatar Foundation Endowment & Gemelli Foundation, Italy in period August 2022 - June 2025, with the aim to evaluate to assess efficacy and safety of different IGB volumes in our cohort.
BACKGROUND Obesity is now recognized as one of the most important public health issues. As excess weight continues to rise, its related comorbidities are also increasing and substantially impact on life expectancy. Population-based studies showed that trajectory of the obesity epidemic in the early childhood and adolescents is also increasing. The worldwide prevalence of excess weight in 1975 for girls was 0.7% and is calculated as 5.6% in 2016, and an increase from 0.9% to 7.8% in 2016 is reported for boys. Due to growing burden of obesity and associated complications there is an unmet need for therapeutical options than those currently available. As the sole nutritional and lifestyle modification is not sufficient in most cases, pharmacological or interventional procedural are often necessary. These led to rapid development of bariatric techniques that are evolving in the past decade . Endoscopic bariatric procedures are considered low-risk procedures and are applicable to the population who are not candidates for bariatric surgery. These procedures are combined with conservative measures for treatment of obesity and related co-morbidities. IGB placement is a bariatric procedure that involves insertion of a balloon in the stomach reducing its volume. They are usually filled with a fluid (saline solution, together with methylene blue) or, less frequently, with gas. IGB therapy effectively achieves short-term weight loss in obese patients in comparison to lifestyle modification alone. There is still no consensus on which is the best filling volume for IGB, that is usually filled according to the physician's expertise, with the aim to tailor the filling on patient's body mass index and stomach dimensions. This study aimed to evaluate weight loss and safety outcome after IGB and to analyze the difference between different filling volumes.
TYPE OF STUDY Single centre, randomized study.
OBJECTIVES The primary objective of the trial will be to compare three different filling volumes of IGB in the treatment of morbid obesity, with a hypothesis that percentage excess weight loss after IGB removal would be equivalent at a different filling volume. The secondary objective will be to test the possible differences between the different filling volumes regarding the percentage of adverse events (AEs), percentage of early IGB removal and quality of life (QOL).
ENDPOINTS Primary endpoint The primary end point will be weight loss defined by percentage of TWL (initial weight minus current weight) / (initial weight) x 100) and percentage EWL (initial weight minus follow-up weight) / (initial weight minus ideal weight for BMI 25) x 100%).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age > 18 years, obesity grade I-III, or overweight with at least one obesity-related comorbidity
排除标准
- •history of bariatric surgery or endoscopy, allergies to methylene blue, childbearing or not willing to participate or comply with follow-up
结局指标
主要结局
Weight loss defined by percentage of Total Weight Loss and Excess Weight Loss
时间窗: From enrollment to the end of treatment at 6 months
The primary end point was weight loss defined by percentage of TWL (initial weight minus current weight) / (initial weight) x 100) and percentage EWL (initial weight minus follow-up weight) / (initial weight minus ideal weight for BMI 25) x 100%).
次要结局
- Adverse events (epigastric pain, nausea and vomiting)(From enrollment to the end of treatment at 6 months)
- Early balloon removal(From enrollment to the end of treatment at 6 months)
- Improvement of disease specific Quality of Life(From enrollment to the end of treatment at 6 months)
研究者
Salvatore F. Vadalà di Prampero
MD, PhD
Mater Olbia Hospital