跳至主要内容
临床试验/NCT04237857
NCT04237857招募中不适用

Long Term Incidence and Effect of Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy in Chinese Population

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Incidence of de novo GERD

研究概览

简要总结

To evaluate the long-term incidence and effects of gastroesophageal reflux disease in the Chinese population after laparoscopic sleeve gastrectomy.

详细描述

Laparoscopic sleeve gastrectomy (SG) has gained popularity as a primary bariatric procedure in the past decade. According to the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), 43.6% of all bariatric procedures performed worldwide were SG between 2013 and 2017. Long term data of SG have shown that the procedure is able to achieve adequate weight loss and metabolic outcomes compared with other bariatric procedures. Furthermore, it has gained popularity due to its relatively simpler procedure, shorter operative time, avoidance of intestinal anatomy rearrangement, anastomosis, risk of internal hernia, and lower risk of malnutrition.

One major drawback to SG is potential development of gastrointestinal reflux disease (GERD). According to the Montreal Classification, GERD is defined as heartburn and regurgitation because of reflux contents of the stomach into the esophagus, causing symptoms that interferes with physical activity, disturbs sleep and reduce productivity at work . It has been shown to significant impact on patients' post-operative quality of life negatively . Currently there are discrepancy in the medical literature, while some studies found worsening of GERD or development of GERD (de novo GERD) after SG, some found improvement of GERD post-operatively. From a recent meta-analysis by Yeung et al comprising 10, 718 patients with follow-up period from 3 to 132 months, 19% of patients experienced worsening of GERD while 23% developed de novo GERD after SG.

Furthermore, long term complications of GERD include the development of erosive esophagitis, Barret's esophagus and even esophageal adenocarcinoma. From the same meta-analysis, the long-term prevalence (>24 months) of erosive esophagitis and Barret's esophagus were 28% and 8% respectively. There have also been isolated case reports of development of esophageal adenocarcinoma after SG. From the investigators' literature review, four cases were reported. Two of the cases had no pre-operative endoscopy, one case had pre-operative diagnosis of Barret's esophagus. The other case developed esophageal adenocarcinoma despite normal pre-operative endoscopy 5 years after SG.

The epidemiology of GERD is different in Western countries and in Asian countries. Although the incidence of GERD has increased in the past decades, the prevalence of GERD was 5.2-8.5% base on symptoms. Prevalence of Barret's esophagus remained rare at 0.06-0.85%. In patents who have received SG, Tai et al showed that the prevalence of GERD increased from 12.1 to 47% based on Reflux Disease Questionnaire at one year after SG. The prevalence of erosive esophagitis also increased from 16.7 to 66.7%. based on upper gastrointestinal endoscopy findings at one year. In the long run, the prevalence of de novo GERD was 17-45% based on symptoms and proton pump inhibitors use from the case series by Pok et al. and Chang et al. with a follow-up period up to 7 years and 10 years respectively.

From the current Asian literature, data on long term incidence of GERD after SG based on objective assessment tools and endoscopy findings was lacking. There is also no adequate data on the long-term occurrence of erosive esophagitis and Barret's esophagus after SG, which would have important significance in pre-operative counselling.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Chinese patients who received laparoscopic sleeve gastrectomy at Prince of Wales Hospital, The Chinese University of Hong Kong
  • SG has been performed more than 36 months
  • Patient received preoperative OGD and GI symptom assessment with C-GIQLI questionnaire
  • Willing and able to consent to the study

排除标准

  • Revisional surgery
  • Concomitant surgeries (except hiatal repair/ cholecystectomy)
  • Mentally incompetent patients or patients less than 18 years old
  • Pregnant patients
  • Unable/unwilling to consent to the study
  • Unable/unwilling to undergo follow-up assessments

结局指标

主要结局

Incidence of de novo GERD

时间窗: >36 months after surgery

Incidence of long term de novo gastroesophageal reflux disease after laparoscopic sleeve gastrectomy, as defined by: Patients who did not have pre-operative GERD; AND patients who scored ≥12 in the Chinese GERDQ questionnaire at ≥36 months after SG; and/or patients who scored ≤5 out of 8 marks in questions 26 (acid reflux) and 34 (heart burn), at ≥36 months after SG; and/or patients who had erosive esophagitis or Barret's esophagus at upper gastrointestinal endoscopy at ≥36 months after SG; and/or patients who required regular anti-reflux medications at ≥36 months after SG

次要结局

  • Changes in severity of GERD(>36 months after surgery)
  • Proportion of asymptomatic patients with endoscopic evidence of de novo GERD(>36 months after surgery)
  • Difference in quality of life in patient with or without de novo GERD(>36 months after surgery)

研究者

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

Cheung Yau Fung

Associate Consultant

Chinese University of Hong Kong

研究点 (1)

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