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

Primary Purpose

Morbid Obesity

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Gastroscopy

About this trial

This is an interventional diagnostic trial for Morbid Obesity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

St Claraspital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Gastric Bypass

Sleeve Gastrectomy

Arm 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

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

Outcomes

Primary Outcome Measures

Incidence of Barrett oesophagus after bariatric surgery

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

Secondary Outcome Measures

Prevalence of dysphagia after bariatric surgery

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

Prevalence of oesophageal motility disorders after bariatric surgery

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

Full Information

NCT ID

NCT03410849

First Posted

January 2, 2018

Last Updated

November 2, 2020

Sponsor

University Hospital, Basel, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT03410849

Brief Title

Long-term Adverse Effects After Bariatric Surgery on Oesophagus Epithelium

Acronym

FUB-B

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

February 1, 2018 (Actual)

Primary Completion Date

September 1, 2020 (Actual)

Study Completion Date

September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Morbid Obesity

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

170 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gastric Bypass

Arm Type

Active Comparator

Arm 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

Arm Title

Sleeve Gastrectomy

Arm Type

Active Comparator

Arm 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

Intervention Type

Diagnostic Test

Intervention Name(s)

Gastroscopy

Intervention Description

in both arms intervention 'gastroscopy' will be carried out

Primary Outcome Measure Information:

Title

Incidence of Barrett oesophagus after bariatric surgery

Description

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

Time Frame

5-7 years after bariatric surgery

Secondary Outcome Measure Information:

Title

Prevalence of dysphagia after bariatric surgery

Description

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

Time Frame

5-7 years after bariatric surgery

Title

Prevalence of oesophageal motility disorders after bariatric surgery

Description

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

Time Frame

5-7 years after bariatric surgery

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bettina Wölnerhanssen, MD

Organizational Affiliation

Clinical Research St Claraspital

Official's Role

Principal Investigator

Facility Information:

Facility Name

St Claraspital

City

Basel

ZIP/Postal Code

4016

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Long-term Adverse Effects After Bariatric Surgery on Oesophagus Epithelium

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