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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT03410849

Collaborator

(none)

170

Enrollment

Location

Arms

Actual Duration (Months)

5.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity	Diagnostic Test: Gastroscopy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

170 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Feb 1, 2018

Actual Primary Completion Date :

Sep 1, 2020

Actual Study Completion Date :

Sep 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of Barrett oesophagus after bariatric surgery [5-7 years 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 [5-7 years 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 [5-7 years after bariatric surgery]
Prevalence of oesophageal motility will be compared to will be compared to reference for this age

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Claraspital	Basel		Switzerland	4016

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT03410849

Other Study ID Numbers:

FUB Study Oesophagus

First Posted:

Jan 25, 2018

Last Update Posted:

Nov 3, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity, Morbid

Long Term Adverse Effects

Study Results

No Results Posted as of Nov 3, 2020