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

November 2, 2020 updated by: University Hospital, Basel, Switzerland

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gastric Bypass
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
Diagnostic test: Gastroscopy
in both arms intervention 'gastroscopy' will be carried out
Active Comparator: Sleeve Gastrectomy
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
Diagnostic test: Gastroscopy
in both arms intervention 'gastroscopy' will be carried out

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5-7 years after bariatric surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5-7 years after bariatric surgery
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
5-7 years after bariatric surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Bettina Wölnerhanssen, MD, Clinical Research St Claraspital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

January 2, 2018

First Submitted That Met QC Criteria

January 18, 2018

First Posted (Actual)

January 25, 2018

Study Record Updates

Last Update Posted (Actual)

November 3, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUB Study Oesophagus

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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