Long-term Adverse Effects After Bariatric Surgery on Oesophagus Epithelium

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Diagnostic Test: Gastroscopy

• Registration Number: NCT03410849
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-25
• Study Start: 2018-02-01
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gastric Bypass	Gastroscopy	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
Sleeve Gastrectomy	Gastroscopy	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

Primary Outcome Measures

Name	Time	Method
Incidence of Barrett oesophagus after bariatric surgery	5-7 years after bariatric surgery	incidence of Barrett oesophagus will be compared to will be compared to reference for this age

Secondary Outcome Measures

Name	Time	Method
Prevalence of oesophageal motility disorders after bariatric surgery	5-7 years after bariatric surgery	Prevalence of oesophageal motility will be compared to will be compared to reference for this age
Prevalence of dysphagia after bariatric surgery	5-7 years after bariatric surgery	Prevalence of dysphagia will be compared to will be compared to reference for this age

Trial Locations

Locations (1)

St Claraspital; 🇨🇭 Basel, Switzerland