Study of Impact of the Size of Gastric Sleeve o the Weight Loss in Patients Submitted to Bariatric Surgery. Evaluation of Changes in Gastric Motility and Endocrine-metabolic Function.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Body mass index
研究概览
简要总结
Morbid Obesity (MO) is considered the most important epidemic in the developed world in the twenty-first century. After initial assessment of morbidly obese patients and the exclusion of potentially correctable causes, management involves a combination of dietary changes, cognitive therapy, physical activity, psychological support and pharmacological treatment. However, any combination of these factors has proven long-term effectiveness in achieving significant and sustained reduction of excess weight. Currently, surgery is the only treatment capable of achieving this goal, interacting also with significant improvement in quality of life and overall long-term mortality.
In recent years, several authors have reported excellent short-term results with performing sleeve gastrectomy, but whether some aspects regarding the variability of gastric tubulization design could influence the results obtained in relation to weight loss and functional changes and gastric hormones.
The main objective of this study is to assess the size of the gastric tubulization (based probe calibration and the distance from the pylorus to which initiate gastric section) that can provide a better clinical outcome (such as excess weight loss) in patients undergoing surgery for morbid obesity. Secondary objectives were to assess the morphological changes, physiological and hormonal obtained according to the size of the gastric tubulization and its effect on weight loss patients.
详细描述
HYPOTHESIS Surgical major factors which determine the size of the gastric pouch after performing a a sleeve gastrectomy are the diameter of the remanent stomach (influenced by the diameter of the bougie size) and the residual antrum.
Whereas gastrectomy is a restrictive procedure, we postulate that the variation of these factors can have a significant impact on clinical outcomes in terms of weight loss and improvement in comorbidities in addition to possible changes in the hormone pattern
OBJECTIVE:
- Primary Outcome Measure:
Weight loss one year after surgery
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more than 18 years and less than 65 years
- •BMI more than 40 kg/m2 or more than 35 kg/m2 with comorbidities likely to improve after weight loss.
- •Morbid obesity established at least five years.
- •Continued failures to adequately supervised conservative treatments
- •Absence of endocrine disorders that are due to morbid obesity.
- •Psychological stability:
- •No alcohol or drug abuse.
- •Absence of major psychiatric disorders (schizophrenia, psychosis), mental retardation, eating disorders (bulimia nervosa).
- •Ability to understand the mechanisms to lose weight with surgery and understand that not always achieved good results.
- •Understand that the goal of surgery is to achieve the ideal weight.
- •Commitment for Adherence to surveillance guidelines after surgery
- •Informed consent after receiving all the necessary information (oral and written).
- •Women of childbearing age should avoid pregnancy for at least the first year after surgery
排除标准
- •No acceptance
- •Age less than 18 years or more than 65 years
- •Previous bariatric surgery
- •Previous gastric surgery
- •Inflammatory bowel disease
结局指标
主要结局
Body mass index
时间窗: 1 year
Gastric volume
时间窗: 1 month and 1 year
次要结局
- Gastric emptying time(1 year)
- Lower esophageal sphincter pressure(1 year)
- Number of gastroesophageal reflux episodes(1 year)