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
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Long Term Adverse Effects
• Morbid Obesity
• Obesity, Morbid

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