Long Term Incidence and Effect of de Novo GERD After Laparoscopic Sleeve Gastrectomy in Chinese Population

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

Detailed Description
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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. The objective of the study is to evaluate the long-term incidence and effects of gastroesophageal reflux disease in the Chinese population after laparoscopic sleeve gastrectomy.

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

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Procedure: Laparoscopic sleeve gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Revisional surgery Concomitant surgeries (except hiatal repair/ cholecystectomy) Mentally incompetent patients or patients less than 18 years old Pregnant patients Inmates Unable/unwilling to consent to the study Unable/unwilling to undergo follow-up assessments
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LSG<br>Chinese patients who received laparoscopic sleeve gastrectomy at Prince of Wales Hospital, The Chinese University of Hong Kong for more than 36 months | Procedure: Laparoscopic sleeve gastrectomy<br>* Laparoscopic sleeve gastrectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of de novo GERD | 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 | >36 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in severity of GERD | Changes in severity of GERD after SG in patients who had pre-operative GERD, defined by increase in anti-reflux medications usage and/or increase in severity of erosive esophagitis or Barret's esophagus at ≥36 months after SG | >36 months after surgery | 
| Proportion of asymptomatic patients with endoscopic evidence of de novo GERD | Proportion of patients who have endoscopic evidence of de novo GERD (erosive esophagitis or Barret's esophagus) but had no symptoms of de novo GERD | >36 months after surgery | 
| Difference in quality of life in patient with or without de novo GERD | Difference in quality of life as measured by C-GIQLI questionnaire between patients who have de novo GERD and patients who do not at ≥36 months after operation | >36 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleeve gastrectomy, Gastroesophageal reflux, Chinese