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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06298162
Acronym
MRI pouch
Enrollment
10
Registered
2024-03-07
Start date
2019-07-25
Completion date
2020-02-01
Last updated
2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Candidate, Gastric Bypass, Obesity, Morbid, Pouch Emptying

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).

Interventions

OTHER2 years after RYGB, no intervention. MRI measurement. Observational.

no intervention. MRI measurement. Observation.

Sponsors

Rijnstate Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 55 Years

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

Design outcomes

Primary

MeasureTime frame
Pouch emptying rate measured with MRITwo years after LRYGB

Secondary

MeasureTime frameDescription
subjective ratings of fullnessTwo years after LRYGBsubjective ratings of fullness will be measured an a 100-unit Visual Analogue Scale
subjective ratings of wellbeingTwo years after LRYGBsubjective ratings of wellbeing will be measured an a 100-unit Visual Analogue Scale

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026