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NCT03410849 Clinical Trial

Long-term Adverse Effects After Bariatric Surgery on Oesophagus Epithelium

Morbid Obesity Clinical Trial

— FUB-B  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03410849
Other study ID # FUB Study Oesophagus
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date September 1, 2020

Study information
Verified date November 2020
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 170
Est. completion date September 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Gastroscopy
in both arms intervention 'gastroscopy' will be carried out

Locations
Country Name City State
Switzerland St Claraspital Basel

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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