Assessment of Pouch Emptying With MRI After Roux-en-Y Gastric Bypass (MRI pouch)

February 29, 2024 updated by: Rijnstate Hospital
A cross-sectional observational study in which pouch emptying rate is measured with MRI in good (TWL>35%) and bad responders (TWL<25%) two years after Laparoscopic Roux-en-Y Gastric Bypass (LRYGB).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

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

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

RYGB, with succesful (>35%) or unsuccesful (<25%) weight loss

Description

Inclusion Criteria:

  • Women aged between 20 and 55 years
  • Patients must be able to adhere to the study visit schedule and protocol requirements
  • Patients must be able to give informed consent (IC) prior to any study procedures
  • Patients who had a follow-up period up until two years after LRYGB and have successful or unsuccessful weight loss.
  • Willing to be informed about incidental findings of pathology and approving of reporting this to their general physician

Exclusion Criteria:

  • Diabetes Mellitus
  • Menopausal
  • Gastrointestinal problems, gastric or intestinal diseases
  • Drug or alcohol addiction
  • Inability to stop smoking during the overnight fasting period
  • Pregnant or lactating
  • Having an intolerance or allergy for one of the components of the test product
  • Inability to stop medications that affect gastrointestinal emptying like antisecretory drugs, narcotics and prokinetic agents
  • Inability to stop medication that affects the motility of the upper gastrointestinal tract (anti-cholinergic drugs, prokinetics, theophylline, calcium blocking agents, opioids)

  • Having a contra-indication to MRI scanning (including, but not limited to):

    • Pacemakers and defibrillators
    • Intraorbital or intraocular metallic fragments
    • Ferromagnetic implants

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RYGB, successful weight loss (TWL >35%)
TWL = total weight loss
Other: 2 years after RYGB, no intervention. MRI measurement. Observational.
no intervention. MRI measurement. Observation.
RYGB, unsuccessful weight loss (TWL <25%)
Other: 2 years after RYGB, no intervention. MRI measurement. Observational.
no intervention. MRI measurement. Observation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pouch emptying rate measured with MRI
Time Frame: Two years after LRYGB
Two years after LRYGB

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subjective ratings of fullness
Time Frame: Two years after LRYGB
subjective ratings of fullness will be measured an a 100-unit Visual Analogue Scale
Two years after LRYGB
subjective ratings of wellbeing
Time Frame: Two years after LRYGB
subjective ratings of wellbeing will be measured an a 100-unit Visual Analogue Scale
Two years after LRYGB

Collaborators and Investigators

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

Sponsor

Rijnstate Hospital

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)

July 25, 2019

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

July 23, 2021

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-1279

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Obesity, Morbid

Clinical Trials on 2 years after RYGB, no intervention. MRI measurement. Observational.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe