Long-term Adverse Effects After Bariatric Surgery on Oesophagus Epithelium

Study Overview
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Brief Summary
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The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB) and sleeve gastrectomy (LSG) on oesophageal symptoms and disease, including the presence of Barrett oesophagus ≥ 5 years post-surgery.

Detailed Description
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Bariatric surgery shows impressive results in terms of weight loss and resolution of comorbidities. Still, there are questions as to the frequency of long-term adverse effects: the prevalence and causes of post-operative swallowing disorders and reflux disease are uncertain. Recently, independent study groups described a high incidence of Barrett oesophagus post LSG. Additional research is urgently needed. The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB) and sleeve gastrectomy (LSG) on oesophageal symptoms and disease, including the presence of Barrett oesophagus ≥ 5 years post-surgery.

Official Title
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Long-term Adverse Effects After Laparoscopic Sleeve Gastrectomy and Roux en Y Gastric Bypass (Part B)

Conditions
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Morbid Obesity

Intervention / Treatment
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* Diagnostic Test: Gastroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who received laparoscopic gastric bypass or laparoscopic sleeve gastrectomy ≥ 5 years ago as a primary bariatric procedure will be eligible for this study. Exclusion Criteria: Patients who received laparoscopic gastric bypass or laparoscopic sleeve gastrectomy as a secondary bariatric procedure (e.g. after gastric banding), Patients who received a secondary bariatric operation after laparoscopic gastric bypass or laparoscopic sleeve gastrectomy( e.g. biliopancreatic diversion)
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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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gastric Bypass<br>A gastroscopy will be carried out to document the presence of inflammation and metaplasia in patients after an average of 5 years after laparoscopic gastric bypass | Diagnostic Test: Gastroscopy<br>* in both arms intervention 'gastroscopy' will be carried out<br>|
| Active Comparator: Sleeve Gastrectomy<br>A gastroscopy will be carried out to document the presence of inflammation and metaplasia in patients after an average of 5 years after laparoscopic sleeve gastrectomy | Diagnostic Test: Gastroscopy<br>* in both arms intervention 'gastroscopy' will be carried out<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Barrett oesophagus after bariatric surgery | incidence of Barrett oesophagus will be compared to will be compared to reference for this age | 5-7 years after bariatric surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of dysphagia after bariatric surgery | Prevalence of dysphagia will be compared to will be compared to reference for this age | 5-7 years after bariatric surgery | 
| Prevalence of oesophageal motility disorders after bariatric surgery | Prevalence of oesophageal motility will be compared to will be compared to reference for this age | 5-7 years after bariatric surgery |