NCT03410849

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

2.6 years

First QC Date

January 2, 2018

Last Update Submit

November 2, 2020

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Prevalence of dysphagia after bariatric surgery

    5-7 years after bariatric surgery

  • Prevalence of oesophageal motility disorders after bariatric surgery

    5-7 years after bariatric surgery

Study Arms (2)

Gastric Bypass

ACTIVE COMPARATOR

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

Sleeve Gastrectomy

ACTIVE COMPARATOR

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

Interventions

GastroscopyDIAGNOSTIC_TEST

in both arms intervention 'gastroscopy' will be carried out

Gastric BypassSleeve Gastrectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who received laparoscopic gastric bypass or laparoscopic sleeve gastrectomy ≥ 5 years ago as a primary bariatric procedure will be eligible for this study.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Claraspital

Basel, 4016, Switzerland

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Bettina Wölnerhanssen, MD

    Clinical Research St Claraspital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2018

First Posted

January 25, 2018

Study Start

February 1, 2018

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

November 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)