Prospective Single-center Study to Evaluate Preoperative and Postoperative Endoscopic Alterations in Patients Submitted to Gastric Bypass Without a Ring.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
Despite the high success rates of gastric bypass in the short and long terms, little is known about possible anatomopathological changes that can occur in these patients. The objective is to investigate preoperative and postoperative endoscopic changes in patients undergoing gastric bypass without a ring. Thirty obese patients from different regions of the country with the surgical indication for the Roux-en-Y gastric bypass will be studied prospectively. All patients will be submitted to upper gastric endoscopy (UGE) two, six and 12 months after the surgical procedure at the Kaiser Clinic. This study will identify whether there are endoscopic changes within one year after the surgery and what they are. Changes, if they exist, will be correlated with clinical data, in order to make an accurate prognosis of the patient, thereby contributing to the outcomes of future patients submitted to this type of procedure.
详细描述
People with severe or morbid obesity often fail to lose weight in the long term. Gastric bypass is considered the gold standard in the surgical treatment of obesity. Despite the high success rates of gastric bypass in the short and long terms, little is known about possible anatomopathological changes that can occur in these patients. UGE has been used on a wide scale in complementary evaluations of patients submitted to bariatric surgery. However, there is still no consensus on the use of imaging tests such as UGE in the follow-up of these patients after surgery. Considering the importance of gastric bypass in the treatment of obesity, knowledge about possible preoperative and postoperative GI alterations identified by endoscopy in these patients may contribute to the establishment of correlations with symptomatology and with the success rate of this technique during follow-ups of up to 12 months.
Organization and infrastructure: This study is organized based on a single location: the Kaiser Clinic and Day Hospital. This center is renowned for the treatment of diseases in the areas of Gastroenterology, Proctology and General Surgery.
Objectives:
General: Demographic, clinical, nutritional, operative and endoscopic data will be assessed.
Specific: The objective of this research will be to investigate preoperative and postoperative endoscopic changes in patients undergoing gastric bypass without a ring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients older than 18 years and younger than 65 years of age;
- •Patients with indication for gastric bypass without ring;
- •Patient attending regular appointments in the Gastroenterology Service.
排除标准
- •Patients younger than 18 and over 65 years of age;
- •Patients who have no indication of gastric bypass without a ring;
- •Pregnant women (a BHCG test will be required from all women of childbearing age).
结局指标
主要结局
Weight loss
时间窗: Before surgery and at 2, 6, 12 and 24 months
weight in kg
次要结局
- Gastrojejunal anastomosis (mm)(Before surgery and at 2, 6, 12 and 24 months)
- The mucosal lesions of the distal esophageal body by Los Angeles Classification(Before surgery and at 2, 6, 12 and 24 months)
- Length of lesser curvature (cm)(Before surgery and at 2, 6, 12 and 24 months)
- Gastric pouch Anteroposterior diameter (cm)(Before surgery and at 2, 6, 12 and 24 months)
- Quality of Afferent loop size as adequate or not.(Before surgery and at 2, 6, 12 and 24 months)
- The mucosal changes in jejunal loops will be studied for any lesion like marginal ulcers(Before surgery and at 2, 6, 12 and 24 months)
- Afferent loop angulation(Before surgery and at 2, 6, 12 and 24 months)