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临床试验/NCT03077906
NCT03077906已完成不适用

Study of Gastro-oesophageal Reflux in Patients Having Had Bariatric Surgery

Pierre Wauthy1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2017年4月1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
400
试验地点
1
主要终点
post-op gastroœsophageal reflux

研究概览

简要总结

Obesity surgery has become commonplace nowadays. This type of surgery is in full swing and although it is mostly beneficial for the health of the patient (reduction of cardiovascular risks, improvement of self image, reduction of osteo-articular risks, etc...) it is however associated with risks. There are several short and long term complications, excluding the ones related to the anesthesia and the post-op recovery: fistulas, abcesses, infections, dysphagia, risks of endobrachyoesophagus, etc...

The gastroœsophageal reflux remains by far the most common post-op complaint within patients. Patients can experience symptoms as far as 3 years after the surgery. Medical treatment alone can in most cases lighten the symptoms. However, in some cases, this treatment fails and another type of surgery (bypass) must be undertaken, which is psychologically traumatic for the patient.

This retrospective study will analyze a cohort of patients who underwent bariatric surgery (mainly sleeve gastrectomy), in order to identify those at risk of developping gastroœsophageal reflux and how this complication can be avoided in pre-op. The study will also identify cases of invalidating gastroœsophageal reflux that can be solved by obesity surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • All patients who had at least 1 year of postoperative follow-up

排除标准

  • Patients who did not have postoperative gastroœsophageal reflux
  • Patients who stopped their postoperative follow-up
  • Patients with unsufficient data collection

结局指标

主要结局

post-op gastroœsophageal reflux

时间窗: 8 years

gastroœsophageal reflux after the surgical intervention

occurence of other surgical interventions

时间窗: 8 years

occurence of other obesity surgical interventions

existing pre-op gastroœsophageal reflux

时间窗: 8 years

existing gastroœsophageal reflux before the surgical intervention

pre-op BMI

时间窗: 8 years

BMI of the patient before the surgical intervention

medical complications

时间窗: 8 years

occurence of medical complications

number of clips used during the surgery

时间窗: 8 years

number of clips used during the surgery

date of birth

时间窗: 8 years

date of birth of the patient

post-op BMI

时间窗: 8 years

BMI of the patient after the surgical intervention

次要结局

未报告次要终点

研究者

发起方
Pierre Wauthy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pierre Wauthy

Head of clinic

Brugmann University Hospital

研究点 (1)

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