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

Bariatric Surgery Candidate Clinical Trial

— MRI pouch  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06298162
• Other study ID #: 2018-1279
• Status: Completed
• Start date: July 25, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: February 2024
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Gender: Female
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Gastric Bypass
• Obesity, Morbid

Intervention

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

Locations

Country	Name	City	State
Netherlands	Yonta Burgh	Arnhem

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pouch emptying rate measured with MRI		Two years after LRYGB
Secondary	subjective ratings of fullness	subjective ratings of fullness will be measured an a 100-unit Visual Analogue Scale	Two years after LRYGB
Secondary	subjective ratings of wellbeing	subjective ratings of wellbeing will be measured an a 100-unit Visual Analogue Scale	Two years after LRYGB