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临床试验/NCT03757650
NCT03757650已完成4 期

THE EFFECT OF HELICOBACTER PYLORI ERADICATION THERAPY TO GASTRIC WALL THICKNESS BEFORE THE LAPAROSCOPIC SLEEVE GASTRECTOMY

Fatih Sultan Mehmet Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2018年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
3
试验地点
1
主要终点
measurements of gastric wall thickness

研究概览

简要总结

Laparoscopic sleeve gastrectomy is one of the most popular bariatric surgery in the world. The most important complication about this surgery that the leakage from the stapler line because of the inconvenient stapler choice..The stapler colour has to be chosen to the gastric wall thickness. It is not known well that the effect of Helicobacter pylori to gastric wall thickness Nobody pay any attention about being Helicobacter pylori positive when they are choosing stapler colour during the Laparoscopic sleeve gastrectomy so that everybody use the same type of stapler in Helicobacter pylori positive and negative patients during the Laparoscopic sleeve gastrectomy .Because of this inconvenient staplers use in the Laparoscopic sleeve gastrectomy the risk of leakage would be increase. Purpose of this research is that what is the effect of Helicobacter pylori to the gastric wall thickness and if the patients who will undergo Laparoscopic sleeve gastrectomy take the Helicobacter pylori eradication therapy before the surgery will gastric wall thickness increase or decrease. .

详细描述

All patients who will undergo to Laparoscopic sleeve gastrectomy have upper gastrointestinal system endoscopy before the surgery in our clinical routine. In our research some patients who has Helicobacter pylori positive endoscopic biopsy will take Helicobacter pylori eradication therapy one month before the surgery and some patients will not take any medication about Helicobacter pylori. All of gastric specimens( Helicobacter pylori positive or negative ) will examine microscopically in the pathology laboratory. The two groups which preoperatively Helicobacter pylori positive detected in endoscopic biopsy will compare with Helicobacter pylori negative control group. Control group will include 30 patients. The other two groups will include 44 patients for each group . The number of patients of group has been determined by power analysis. Gastric specimen will be examined by 3 points ; fundus, corpus, antrum. All of microscopic measurements will be done from that points from minor curvatura. These 3 points ; fundus( 1 cm from the top of staple line) , corpus (middle of the staple line) , antrum ( 1 cm far from the bottom of staple line ). All these points 5 mm far from the minor curvatura. These 3 points will examine about wall thickness (mucosa- submucosa-muscularis propria -serosa ) and the status of Helicobacter pylori. The end of the study it can be determined the effect of Helicobacter pylori to the gastric wall thickness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients who will undergo to LSG will have upper gastrointestinal system endoscopy before the surgery and positive HP results.

排除标准

  • Having allergy to the medications which use for the HP eradication therapy
  • The patients who is incompatible for the HP eradication therapy
  • The patients who decided to undergo to another bariatric surgery peroperatively

研究组 & 干预措施

HP eradication therapy positive-HP positive

Active Comparator

who has HP positive endoscopic biopsy will take HP eradication therapy one month before the surgery

干预措施: Bismuth Subsalicylate (Drug)

HP eradication therapy negative-HP positive

Active Comparator

who has HP positive endoscopic biopsy and will not take any medication about HP

干预措施: Bismuth Subsalicylate (Drug)

结局指标

主要结局

measurements of gastric wall thickness

时间窗: one month

The effect of Helicobacter Pylori eradication therapy to the gastric wall thickness

次要结局

  • Choosing the correct stapler colour during Laparoscopic Sleeve Gastrectomy by accounting gastric wall thickness thanks to knowing effect of HP positivity to gastric wall thickness(one month)

研究者

发起方
Fatih Sultan Mehmet Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

ANIL ERGIN

Dr Anil ERGIN , General Surgery , Asistant doctor

Fatih Sultan Mehmet Training and Research Hospital

研究点 (1)

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