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临床试验/NCT04323072
NCT04323072已完成不适用

Influence of the Size of the Gastric Antrum After Sleeve Gastrectomy on Weight Loss in Bariatric Surgery

Azienda Sanitaria Locale Napoli 2 Nord2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Postoperative weight and height combined to report BMI in kg/m^2

研究概览

简要总结

Laparoscopic sleeve gastrectomy (LSG) is currently the most frequent primary bariatric procedure performed worldwide. LSG is safe and effective in terms of excess weight loss. It is a powerful metabolic operation that activates significant hormonal pathways that lead to changes in eating behaviour, glycemic control and intestinal functions. LSG is easier regarding its technical aspects and does not need any intestinal anastomosis, begin limited to the stomach. The most frequent and sometimes dangerous complications are leaking, haemorrhage, splenic injury, sleeve stenosis and gastroesophageal reflux. Despite its established efficacy and safety, controversy still exists on optimal operative technique for LSG: bougie size, the distance of resection margin from the pylorus, the shape of the section at the gastroesophageal junction, staple line reinforcement and intraoperative leak testing is among the most controversial issues 11[6]. In literature, different authors have adopted a resection distance from the pylorus between 2 and 6-7 cm with various reasons 11[6]. Resections more distant to the pylorus improve gastric emptying, prevent distal stenosis and reduce intraluminal pressure, potentially leading to a lower incidence of fistula and/or reflux. On the other hand, resections close to the pylorus would reduce gastric distensibility and increase intragastric pressure, potentially increasing satiety with less oral intake 11(11,12). The primary aim of this randomized monocentric study is to evaluate %EWL at 1 and 2 years follow-up after LSG in two Groups: Group A with a gastric resection starting from 2 cm from the pylorus with therefore a wide antrectomy and Group B with a gastric resection starting from 6 cm from the pylorus with therefore a small antrectomy.

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
Single (Investigator)

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

  • informed consent.
  • morbid obesity defined as body mass index (BMI) 40 kg/m2

排除标准

  • previous bariatric surgical procedures,
  • endocrine disorders causing obesity
  • pregnancy or lactation
  • psychiatric illness
  • inflammatory bowel disease
  • Barrett ́s oesophagus
  • severe GERD with esophagitis B and C
  • a large hiatal hernia (>5 cm)
  • GERD-HRQLscore > 25 dietary restriction despite

结局指标

主要结局

Postoperative weight and height combined to report BMI in kg/m^2

时间窗: 24 months

Change of weight and height expressed in Postoperative Body Mass Index obtained by dividing the weight by the squared height expressed in meters (kg/m2)

Postoperative percentage excess weigth loss

时间窗: 24 months

Change of weight expressed in percentage of excess weight loss postoperatively at follow-up

次要结局

  • Gastroesophageal reflux disease(GERD)(at 24 months)
  • Gastroesophageal reflux disease symptoms(at 24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Pizza

Head of the bariatric and metabolic surgery unit

Azienda Sanitaria Locale Napoli 2 Nord

研究点 (2)

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