Long-term Adverse Effects After Bariatric Surgery on Oesophagus Epithelium (FUB-B)

University Hospital Basel

Status: Completed

Conditions: Morbid Obesity

Treatments: Diagnostic Test: Gastroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03410849

FUB Study Oesophagus

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Gastric Bypass

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Gastroscopy

Sleeve Gastrectomy

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Gastroscopy