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临床试验/NCT07486765
NCT07486765已完成不适用

Laparoscopic FundoRing Roux-en-Y Gastric Bypass Versus FundoRingOAGB: a Randomized Clinical Trial

The Society of Bariatric and Metabolic Surgeons of Kazakhstan1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年7月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Compare the number of participants with postoperative reflux gastritis in each groups

研究概览

简要总结

Metabolic and bariatric surgery (MBS) is an effective and durable treatment of severe obesity and its co-morbidities.

Gastric bypass is one of the main MBS procedures and is performed using various surgical techniques. The main postoperative bariatric complication after one anastomosis gastric bypass (OAGB) is bile reflux, and the main disadvantage of traditional Roux-en-Y gastric bypass (RYGB) is dumping syndrome.

The successful strategies for avoiding reflux esophagitis and other complication following gastric bypass is the use FundoRing method for gastric bypass with creation fundoplication employing the excluded (remnant) part of the stomach. Routine use of a modified fundoplication of the OAGB-excluded stomach to treat patients with obesity decreased acid and prevented bile reflux esophagitis significantly more effectively than standard OAGB. However, the anastomosis after OAGB is constantly bathed in bile. This was previously thought to significantly increase the risk of ulcers, but modern data shows that bile may even have a "protective" buffering effect, neutralizing acid, although the risk of alkaline gastritis remains. The results of trial of consequences of reflux bile flow from the intestine into the gastric pouch after OAGB are controversial. How does this affect the incidence of marginal ulcers due to enterogastric reflux? The answers to these questions remain unclear.

The aim of the study was to compare the incidence of distal gastric pouch inflammation and the likelihood of marginal ulcers in patients treated with the FundoRing Roux-en-Y gastric bypass versus the FundoRing OAGB.

详细描述

Laparoscopic gastric bypass is a minimally invasive weight loss surgery that reduces the stomach's volume to 20 ml and reroutes the small intestine from the gastric pouch, bypassing the duodenum, into the jejunum, limiting food intake and reducing calorie absorption. This technique also involves creating an enteroenterostomy for a variant of the Roux-en-Y procedure. This procedure involves five small incisions, resulting in a faster recovery and fewer complications compared to traditional open surgery.

With an increasing global metabolic and bariatric surgery (MBS) experience, long-term studies have proven it an effective and durable treatment of severe obesity and its co-morbidities. MBS should be considered a safe and effective primary treatment option or when modern pharmacotherapy does not have an optimal clinical response.

Gastric bypass is one of the main MBS procedures and is performed using various surgical techniques. The main postoperative bariatric complication after one anastomosis gastric bypass (OAGB) is bile reflux, and the main disadvantage of traditional Roux-en-Y gastric bypass (RYGB) is dumping syndrome.

The successful strategies for avoiding reflux esophagitis and other complication following gastric bypass is the use FundoRing method for gastric bypass with creation fundoplication employing the excluded (remnant) part of the stomach. Routine use of a modified fundoplication of the OAGB-excluded stomach to treat patients with obesity decreased acid and prevented bile reflux esophagitis significantly more effectively than standard OAGB at 1 year in a randomized controlled trial]. However, the anastomosis after OAGB is constantly bathed in bile. This was previously thought to significantly increase the risk of ulcers, but modern data shows that bile may even have a "protective" buffering effect, neutralizing acid, although the risk of alkaline gastritis remains. The results of trial of consequences of reflux bile flow from the intestine into the gastric pouch after OAGB are controversial. How does this affect the incidence of marginal ulcers due to enterogastric reflux? The answers to these questions remain unclear.

Therefore, the primary objective of the study was to compare the incidence of distal gastric pouch inflammation and the likelihood of marginal ulcers in patients treated with the FundoRing Roux-en-Y gastric bypass versus the FundoRing OAGB.

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

入选标准

  • BMI 30-50 kg/m2

排除标准

  • BMI <30 and >50 kg/m2

结局指标

主要结局

Compare the number of participants with postoperative reflux gastritis in each groups

时间窗: 1, 3, 6, 12, 24, 36 month after surgery

Compare the number of participants with endoscopically detected incidence of postoperative reflux gastritis in each group.

Compare the number of participants with marginal ulcers of gastroenteroanastomosis in each groups

时间窗: 1, 3, 6, 12, 24, 36 month after surgery

Number of participants with endoscopic Identification of the frequency of marginal ulcers in gastroenteroanastomosis in two groups

Change of body masse index (BMI) in two groups

时间窗: 1, 2, 3 year after surgery

Weight (kg) and height (meter) will reported combined as mean BMI in kg/m2 in each groups

次要结局

未报告次要终点

研究者

发起方
The Society of Bariatric and Metabolic Surgeons of Kazakhstan
申办方类型
Other
责任方
Sponsor

研究点 (1)

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