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OpenTrials
Completed

NCT Number: NCT06298162

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

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).

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Key information

Conditions

Bariatric Surgery Candidate Body Weight Gastric Bypass Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pouch Emptying Signs and Symptoms

Age range

20 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Yonta Burgh

Arnhem, 6815 AD, Netherlands

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

no intervention. MRI measurement. Observation.

Primary outcomes

  1. Pouch emptying rate measured with MRI

    Time frame: Two years after LRYGB

Secondary outcomes

  1. subjective ratings of fullness

    Time frame: Two years after LRYGB

    subjective ratings of fullness will be measured an a 100-unit Visual Analogue Scale

  2. subjective ratings of wellbeing

    Time frame: Two years after LRYGB

    subjective ratings of wellbeing will be measured an a 100-unit Visual Analogue Scale

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Acronym: MRI pouch

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 7, 2024
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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