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OpenTrials
Completed

NCT Number: NCT03410849

Long-term Adverse Effects After Bariatric Surgery on Oesophagus Epithelium

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.

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Claraspital

Basel, 4016, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gastroscopy

Diagnostic Test

in both arms intervention 'gastroscopy' will be carried out

Primary outcomes

  1. Incidence of Barrett oesophagus after bariatric surgery

    Time frame: 5-7 years after bariatric surgery

    incidence of Barrett oesophagus will be compared to will be compared to reference for this age

Secondary outcomes

  1. Prevalence of dysphagia after bariatric surgery

    Time frame: 5-7 years after bariatric surgery

    Prevalence of dysphagia will be compared to will be compared to reference for this age

  2. Prevalence of oesophageal motility disorders after bariatric surgery

    Time frame: 5-7 years after bariatric surgery

    Prevalence of oesophageal motility will be compared to will be compared to reference for this age

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: FUB-B

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 25, 2018
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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