跳至主要内容
临床试验/NCT02142998
NCT02142998暂停不适用

A Prospective Blinded Randomized Study Comparing Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-y Gastric Bypass and Their Effect on Gastro-Esophageal Reflux Disease Using 24 Horus pH Monitoring

McMaster University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
100
试验地点
2
主要终点
Observe acid exposure to the distal esophagus

研究概览

简要总结

Obesity has become a significant health problem in Canada. It is known to be a risk factor for many diseases, including Gastro-Esophageal Reflux Disease (GERD). When medical efforts to lose weight fail, patients often consider bariatric surgical procedures as the next step. The two most common bariatric procedures performed are Roux-en-Y Gastric Bypass (LRYGB) and Laparoscopic Sleeve Gastrectomy (LSG). The gold standard for diagnosing GERD is Esophageal pH monitoring, as it is the most objective method to document the reflux, assess the severity and monitor the response to treatment of the disease. In the last few years LSG has gained in popularity due to its simplicity and short operative time. Currently the comparison between bariatric surgery and GERD symptoms is very one sided. There are significant numbers of studies with conclusive results that state that LRYGB has a positive effect on GERD symptoms, however there is little evidence that states the same about LSG. This means that the relationship between LSG and GERD is inconclusive. An objective evaluation of GERD using 24 hour pH monitoring and validated CRFs at different follow up time points will contribute greatly to our understanding of what this relationship might be.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
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

  • Fulfilled criteria for bariatric surgery as coined by National Institutes of Health conference.
  • Their age is ≥18 years and ≤70 years
  • The group with symptoms of GERD needs to have diagnosis of GERD in their medical record and taking proton pump inhibitors on a daily basis.
  • Able and willing to give written consent
  • The patient is willing to perform the pre-operative tests required for this study.
  • The patient fits for both surgeries - LSG or LRYGB

排除标准

  • Previous bariatric surgery
  • Previous anti reflux procedure
  • Contra-indication to general anesthesia
  • Any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
  • Pregnant or lactating female (Women of child bearing potential must take a pregnancy test prior to surgery)
  • Hiatal hernia above 4cm (measured in the pre-operative gastroscopy).
  • Multiple surgeries in abdominal cavity or previous small bowel disease/resection
  • Patient on CPAP treatment for his OSA disease

结局指标

主要结局

Observe acid exposure to the distal esophagus

时间窗: 1 year

This will be measured using the esophageal 24 hours monitoring before surgery and at the 6 month follow up. The patients will be randomized to two different types of surgery and the results compared.

次要结局

  • Compare GERD symptoms in patients.(1 year)

研究者

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

Mehran Anvari

Doctor

McMaster University

研究点 (2)

Loading locations...

相似试验