Comparative Study Between One Anastomosis Gastric Bypass (OAGB) at Different Lengths of 150, 170, and 200 cm From the Duodenojejunal Junction Regarding Weight Loss and Nutritional Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Percentage of Total Weight Loss
研究概览
简要总结
This study is a randomized clinical trial comparing the effects of One Anastomosis Gastric Bypass performed at three different distances from the duodenojejunal junction-150 centimeters, 170 centimeters, and 200 centimeters-on weight loss outcomes and nutritional status in patients with obesity. One Anastomosis Gastric Bypass is a type of bariatric surgery that combines aspects of a gastric sleeve and a traditional gastric bypass, aiming to achieve effective weight loss and improvement in health conditions associated with obesity.
The study will include 60 adult patients between 18 and 60 years old with a Body Mass Index of 35 kilograms per square meter or greater, or a Body Mass Index of 30 kilograms per square meter or greater with obesity-related health conditions, who have not achieved adequate results through diet, exercise, or medication. Participants will be randomly assigned to one of three groups, each undergoing One Anastomosis Gastric Bypass with a different limb length from the duodenojejunal junction: 150 centimeters, 170 centimeters, or 200 centimeters.
The primary outcomes measured will include the percentage of total weight loss, the percentage of excess weight loss, and postoperative nutritional status, particularly in terms of levels of albumin, calcium, iron, and ferritin. Secondary outcomes will assess the remission of health conditions related to obesity, including high blood pressure and type 2 diabetes mellitus, as well as patient quality of life following surgery.
By examining the impact of One Anastomosis Gastric Bypass at varying limb lengths on weight loss and nutritional deficiencies, this study aims to identify an optimal surgical approach that balances effective weight management and minimizes the risk of postoperative malnutrition. The findings will inform surgical decision-making and postoperative management strategies for individuals undergoing One Anastomosis Gastric Bypass.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 60 years.
- •Body Mass Index (BMI) of 35 kg/m² or higher, or BMI of 30 kg/m² or higher with significant obesity-related comorbidities.
- •Failed adequate conservative management (diet, exercise, and/or medication) for at least 6 months.
- •Demonstrated psychological stability and motivation for surgery.
- •Acceptance of the surgical risks associated with bariatric procedures.
排除标准
- •Prior abdominal exploratory surgery.
- •Previous bariatric surgery.
- •Pre-existing significant nutritional deficiencies.
- •Pregnancy or current lactation.
- •Severe, long-standing cardiac or pulmonary disease or other serious systemic illnesses.
- •Active substance or alcohol abuse.
- •Active gastric ulcer disease.
- •Psychological instability.
结局指标
主要结局
Percentage of Total Weight Loss
时间窗: 12 months post-surgery
This outcome measures the percentage of total weight loss achieved by participants one year after undergoing One Anastomosis Gastric Bypass at specified lengths (150 cm, 170 cm, or 200 cm from the duodenojejunal junction). Total weight loss is calculated as the percentage change in body weight from the initial weight measured preoperatively. This measure provides insight into the effectiveness of different bypass lengths in achieving weight loss in patients with obesity.
Incidence of Nutritional Deficiency in Albumin
时间窗: 12 months post-surgery
This outcome measures the incidence of albumin deficiency in participants one year after undergoing One Anastomosis Gastric Bypass surgery at 150 cm, 170 cm, or 200 cm from the duodenojejunal junction. Albumin deficiency is defined as serum albumin levels below 3.0 g/dL, indicating a risk of protein malnutrition. This outcome will help assess the nutritional impact of different bypass lengths.
Incidence of Nutritional Deficiency in Calcium
时间窗: 12 months post-surgery
This outcome measures the incidence of calcium deficiency in participants one year after undergoing One Anastomosis Gastric Bypass surgery at 150 cm, 170 cm, or 200 cm from the duodenojejunal junction. Calcium deficiency is defined as serum calcium levels below 8.5 mg/dL, which can indicate a risk of bone health complications and overall nutritional deficiency. This measure will evaluate the impact of different bypass lengths on calcium levels.
Incidence of Nutritional Deficiency in Iron
时间窗: 12 months post-surgery
This outcome measures the incidence of iron deficiency in participants one year after undergoing One Anastomosis Gastric Bypass surgery at 150 cm, 170 cm, or 200 cm from the duodenojejunal junction. Iron deficiency is defined as serum iron levels below 50 µg/dL, indicating a risk of anemia and associated health complications. This outcome will help assess the influence of different bypass lengths on iron absorption and nutritional status.
次要结局
- Remission Rate of Type 2 Diabetes Mellitus(12 months post-surgery)
- Improvement in Hypertension(12 months post-surgery)
研究者
Abdelkarem Ahmed Abdelkarem Mohamed
Lecturer of General Surgery, Faculty of Medicine - Cairo University, Egypt
Cairo University