One Anastomosis Gastric Bypass (OAGB) vs Duodeno-jejunostomy For Treatment of Superior Mesenteric Artery Syndrome: A Prospective Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Improvement in Postprandial Symptoms Scores
研究概览
简要总结
The goal of this clinical trial is to find out which surgery works better to treat people with a rare condition called Superior Mesenteric Artery Syndrome (SMAS). This condition causes the duodenum to be squeezed between two arteries, leading to severe nausea, vomiting, and weight loss. The researchers are comparing two types of surgery:
- One Anastomosis Gastric Bypass (OAGB)
- Duodeno-jejunostomy (DJ)
The main questions this study will answer are:
- Which surgery improves symptoms and nutritional status better?
- Which surgery leads to fewer complications and better quality of life?
Participants will:
- Be randomly assigned to one of the two surgeries
- Be followed for 12 months after the operation
- Complete follow-up visits and nutritional assessments
- Answer questions about their symptoms and overall well-being
详细描述
Superior Mesenteric Artery Syndrome (SMAS) is a rare but serious condition where part of the small intestine (the duodenum) gets compressed between major blood vessels. This can cause severe digestive symptoms and weight loss. Surgery is often needed when other treatments do not work.
This prospective randomized controlled trial compares two surgical options to relieve the compression: One Anastomosis Gastric Bypass (OAGB) and Duodeno-jejunostomy (DJ). Both surgeries aim to improve food passage and relieve symptoms, but they work differently and have different effects on digestion and nutrition.
Participants will be randomly assigned to one of the two surgical procedures. The study will collect data before and after surgery on symptoms, nutritional status, complications, and quality of life. Follow-up will continue for 12 months.
The goal is to help surgeons and patients choose the most effective and safest surgical treatment for SMAS.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Superior Mesenteric Artery Syndrome (SMAS) based on symptoms and radiologic findings
- •No prior gastric or intestinal surgery
- •Willingness and ability to participate in follow-up for 12 months
排除标准
- •Presence of other gastrointestinal pathologies mimicking SMAS
- •Severe comorbidities contraindicating surgery (e.g., advanced cardiac or pulmonary disease)
- •History of previous bariatric or upper GI surgery
- •Refusal or inability to provide informed consent
研究组 & 干预措施
OAGB Surgery Group
Participants in this arm will undergo One Anastomosis Gastric Bypass (OAGB). The procedure involves creating a long gastric pouch and connecting it to a loop of the jejunum. This reroutes food to bypass the compressed duodenum, aiming to relieve symptoms of Superior Mesenteric Artery Syndrome (SMAS) while preserving nutritional status.
干预措施: One Anastomosis Gastric Bypass (Procedure)
Duodenojejunostomy Group
Participants in this arm will undergo Duodenojejunostomy (DJ), a surgical procedure in which a bypass connection is made between the duodenum and the jejunum. This relieves the duodenal compression caused by SMAS and restores normal food passage.
干预措施: Duodenojejunostomy (Procedure)
结局指标
主要结局
Improvement in Postprandial Symptoms Scores
时间窗: 12 months
Change in severity of postprandial symptoms (e.g., nausea, vomiting, early satiety, abdominal pain), assessed using standardized scoring tools: the Numeric Rating Scale (NRS) and the Visual Analog Scale (VAS). Both scales range from 0 to 10, where 0 indicates no symptoms and 10 indicates the most severe symptoms imaginable. Higher scores reflect worse symptom severity. The Functional Living Index-Emesis (FLIE) score used to assess nausea and vomiting improvement.
次要结局
- Change in Body Mass Index (BMI)(12 months)