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

NCT ID: NCT06298162

Last Updated: 2024-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-25

Study Completion Date

2020-02-01

Brief Summary

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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).

Detailed Description

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Conditions

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Bariatric Surgery Candidate Gastric Bypass Obesity, Morbid Pouch Emptying

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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RYGB, successful weight loss (TWL >35%)

TWL = total weight loss

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

Intervention Type OTHER

no intervention. MRI measurement. Observation.

RYGB, unsuccessful weight loss (TWL <25%)

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

Intervention Type OTHER

no intervention. MRI measurement. Observation.

Interventions

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

no intervention. MRI measurement. Observation.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rijnstate Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yonta Burgh

Arnhem, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2018-1279

Identifier Type: -

Identifier Source: org_study_id

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