Endoscopic Gastroplasty for Treatment of Obesity: a Single Centre, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- Percentage of Total Body Weight Loss (TBWL percent)
研究概览
简要总结
A single-center, randomized trial will be conducted in order to compare three Endoscopic Gastroplasty (EG) techniques in obese patients (BMI 30-44.99 kg/m2) at Gastroenterology and Gastrointestinal Endoscopy Unit, Mater Olbia Hospital, Qatar Foundation Endowment & Gemelli Foundation, Italy in period June 2020 - August 2024, with the aim to compare the efficacy and safety of these procedures.
详细描述
BACKROUND Obesity has reached epidemic proportions in the world affecting nowadays, along with overweight, over a third of the world's population. It is a chronic multifactorial illness that can lead to potentially life threatening diseases (such as metabolic disorders, cardiovascular disease, stroke, liver disease, and cancer) that can be prevented and improved by weight loss.
A widely accepted option for the treatment of obesity is the endoscopic approach by many different techniques, ranging from the placement of an intragastric balloon (IGB) to the EG, that are nowadays available in the clinical practice as three techniques: Endoscopic Sleeve Gastroplasty (ESG) with Overstitch Endoscopic Suturing Device (Apollo Overstitch), Endoluminal Vertical Gastroplasty (EVG) with an endoluminal-suturing device (Endomina), and Primary Obesity Surgery Endolumenal-2 (POSE-2). Basically, Bariatric Endoscopy (BE) has two mechanism of action. The first one consists in reduction of the stomach capacity and the second one is alteration of gastric motility.
The major advantages of BE techniques consist in their lower invasiveness compared to surgery, reversibility, short hospital stay, and cost-effectiveness. For instance, laparoscopic sleeve gastrectomy (LSG) is the most performed bariatric surgery procedure that is effective but is associated with important adverse events as bleeding from the staple line that can occur in up to 5% of the procedures, gastric leak and persistent fistulas that can occur in up to 8% the LSG.
The weight reduction is conditioned by patient gastric capacity and treatment duration but also the change in the attitude of the patient towards food and physical activity may be fundamental. It is therefore important that the patient is motivated to lose weight and aware of the consequences of his behaviour.
As at the moment many BE techniques are available and most of them are often interchangeable, it could be important to start clarifying if there are any differences among them in terms of their safety and efficacy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years old;
- •acceptance of written informed consent to undergo an EG;
- •capability to understand and comply with the study protocol;
- •obesity: a BMI of 30-34.99 kg/m2 with previous failed attempts at diet and with obesity-related diseases, a BMI of 35-39.99 kg/m2 with previous failed attempts at diet and with or without obesity-related diseases, a BMI of 40-44.99 kg/m2 with previous failed attempts at diet and with or without obesity-related diseases not fit for surgery.
排除标准
- •patients who do not give their consent to the enrollment in the study or are incompetent, unconscious or unable to express their consent for any reason;
- •patients suffering from any condition which precludes compliance with study instructions;
- •patients who underwent previous attempts at surgical or endoscopic bariatric therapy;
- •patient has any allergy or other known contraindication or intolerance to the medications used in the study;
- •women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice methods of contraception;
- •patient suffers from a life threatening condition.
结局指标
主要结局
Percentage of Total Body Weight Loss (TBWL percent)
时间窗: at 30±15, 90±30, 180±30, 360±30, 540±30 days after the procedure
To evaluate the percentage of Total Body Weight Loss after each endoscopic bariatric procedure
次要结局
- Percentage of Excess Weight Loss (EWL percent)(at 30±15, 90±30, 180±30, 360±30, 540±30 days after the procedure)
- Safety in terms of occurrance intra-procedural, post-procedural and late adverse events (AEs).(intra-procedural, up to 14 days and any time after 14 days)
- Technical success rate(intra-procedural)
- Pain procedure-related(the day before the procedure, at 12, 24 hours after the procedure)
- Vomit procedure-related(at 12, 24 hours after the procedure)
- Nausea procedure-related(at 12, 24 hours after the procedure)
- Procedure time differences among the procedures used(intra-procedural)
- Quantity of devices and accessories used during the procedures(intra-procedural)
- Quality of life (QoL) of endoscopic bariatric procedures(before the procedure (when required by the test) and 1,3,6,12,18,24,36 months after the procedure)
- Hepatic steatosis(before the procedure (at baseline) and 3±1 months after the procedure)
- Transit time(before the procedure (at baseline) and 3±1 months after the procedure)
研究者
Salvatore F. Vadalà di Prampero
Principal Investigator
Mater Olbia Hospital