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

R

Rijnstate Hospital

Status

Completed

Conditions

Gastric Bypass
Bariatric Surgery Candidate
Pouch Emptying
Obesity, Morbid

Treatments

Other: 2 years after RYGB, no intervention. MRI measurement. Observational.

Study type

Observational

Funder types

Other

Identifiers

NCT06298162
2018-1279

Details and patient eligibility

About

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).

Enrollment

10 patients

Sex

Female

Ages

20 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

10 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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