Assessment of Pouch Emptying With MRI After Roux-en-Y Gastric Bypass
MRI pouch
1 other identifier
observational
10
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedFirst Submitted
Initial submission to the registry
July 23, 2021
CompletedFirst Posted
Study publicly available on registry
March 7, 2024
CompletedMarch 7, 2024
February 1, 2024
6 months
July 23, 2021
February 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Pouch emptying rate measured with MRI
Two years after LRYGB
Secondary Outcomes (2)
subjective ratings of fullness
Two years after LRYGB
subjective ratings of wellbeing
Two years after LRYGB
Study Arms (2)
RYGB, successful weight loss (TWL >35%)
TWL = total weight loss
RYGB, unsuccessful weight loss (TWL <25%)
Interventions
no intervention. MRI measurement. Observation.
Eligibility Criteria
RYGB, with succesful (\>35%) or unsuccesful (\<25%) weight loss
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonta Burgh
Arnhem, 6815 AD, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2021
First Posted
March 7, 2024
Study Start
July 25, 2019
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
March 7, 2024
Record last verified: 2024-02