Impact of Gastroenteroanastomosis Simultaneous to Vertical Gastrectomy on Post-operative Gastroesophageal Reflux
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- GERD in endoscopy
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of GEA on GERD in patients undergoing VSG. The main question it aims to answer is:
• Does adoption of GEA to VSG reduce the occurrence of GERD? Participants will complete a symptom questionnaire during follow-up visits. All exams are already part of the surgical or GERD follow-up routine.
Researchers will compare with GEA (Group A) and Without GEA (Group B) to see if adopting GEA during VSG reduces the occurrence of GERD.
详细描述
All patients aged between 18 and 65 years old who are candidates for bariatric surgery, who opt for VSG, will be consecutively invited to participate in the open study. Initially, patients will be allocated into two groups, matched by BMI and age. Regarding age, they will be separated into two categories: between 18 and 40 years old, ≥40 years old. Regarding BMI, they will be divided into two groups: BMI<40 and BMI≥40. After being allocated according to weight criteria, the randomization for the GEA will proceed through a draw during the surgical procedure, after making the gastric tube. So, we will have two groups: With GEA (Group A); and Without GEA (Group B), both with 30 patients each, totaling 60 research participants. All patients will be evaluated for GERD before, 12, 24 and 60 months after surgery, and will have permanent access to the team regarding the details of their operations that may be necessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •All VSG candidate patients aged >18 and <65 years and BMI≥ 35 and BMI≤50 who agree to participate in the study
排除标准
- •Presence of reflux esophagitis according to the Lyon Consensus
- •Previous gastric surgery
- •Esophagus' motor diseases
- •Development of chronic diseases associated with the use of medications such as chemotherapy, anti-rheumatics, etc.
- •Patients who fail to undergo the study exams during follow-up or who withdraw the informed consent form (TCLE) at any time during the study
研究组 & 干预措施
Group A
adoption of GEA to VSG
干预措施: gastroenteroanastomosis simultaneous to vertical sleeve gastrectomy (Procedure)
Group A
adoption of GEA to VSG
干预措施: vertical sleeve gastrectomy (Procedure)
Group B
Without GEA to VSG
干预措施: vertical sleeve gastrectomy (Procedure)
结局指标
主要结局
GERD in endoscopy
时间窗: until 60 months
decrease or absence of esophagitis, detected by endoscopy (Los Angeles classification), and esophageal acid exposure, detected by pH monitoring, in the group with GEA
GERD symptoms
时间窗: until 60 months
improvement or absence of GERD symptoms reported by the patient in consultation and QS-GERD. The QS-GERD (Gastroesophageal Reflux Disease Symptom Questionnaire) is a self-administered tool designed to diagnose and quantify the intensity of GERD symptoms. It consists of approximately 11 questions (including self-perceived health), assessing typical and atypical symptoms, with scores ranging from 0 to 50 or 55, indicating the severity of reflux.
次要结局
- weight loss(until 60 months)
研究者
Carlos AS Madalosso
Director
Clinica Gastrobese