Gastric Emptying After Sleeve Gastrectomy (EMRISS)

March 30, 2026 updated by: Rijnstate Hospital

Gastric Emptying Measured With MRI and Scintigraphy in Patients With Successful Versus Unsuccessful Weight Loss After Sleeve Gastrectomy

Sleeve gastrectomy (SG) increases gastrointestinal motility, which influences feelings of fullness and satiety. By understanding the differences in gastric emptying (GE) between patients with sufficient weight loss (Total weight loss [TWL] > 35%) and insufficient weight loss (TWL < 25%), better insight in the aetiology of weight loss after sleeve gastrectomy may be obtained. GE will be measured with scintigraphy and MRI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sleeve gastrectomy (SG) increases gastrointestinal motility, which influences feelings of fullness and satiety. Patients' weight loss response on SG varies widely and is difficult to predict. By understanding the differences in gastric emptying (GE) between patients with sufficient weight loss (Total weight loss [TWL] > 35%) and insufficient weight loss (TWL < 25%), better insight in the aetiology of weight loss after sleeve gastrectomy may be obtained. GE will be measured with scintigraphy and MRI. MRI is a non-invasive imaging method which provides more detailed images of the SG compared to the conventionally used scintigraphy scans.

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815AD
        • Rijnstate Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Women after sleeve gastrectomy with either good or poor weight loss

Description

Inclusion Criteria:

  • Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with either TWL < 25% or TWL > 35%.
  • Patients who had a follow-up period of 2-3 years after sleeve gastrectomy

Exclusion Criteria:

  • Maximum BMI >50 kg/m2
  • Patients with a disease known to affect appetite, gastric emptying or gastrointestinal motility
  • Patients who are unable to stop medications that affect gastric emptying and/or motility prior to measurements. It is depending on t1/2 for how long they need to stop medication
  • Patients who started menopause
  • Patients with gastrointestinal problems or, gastric or intestinal diseases
  • Patients with a drug or alcohol addiction
  • Patients who are unable to stop smoking for 24h
  • Patients who are pregnant or lactating
  • Patients who have an intolerance or allergy for one of the components of the test product
  • Patients who have a contra-indication to MRI scanning

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Poor weight loss group
Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with TWL < 25%
Other: MRI and scintigraphy
Gastric emptying measured with MRI and scintigraphy
Successful weight loss group
Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with TWL > 35%
Other: MRI and scintigraphy
Gastric emptying measured with MRI and scintigraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric emptying compared between patients with poor and successful weight loss
Time Frame: 2-3 years
Gastric emptying (T1/2 [min] and retention [%/min])
2-3 years
Gastric emptying compared between measured with MRI and scintigraphy
Time Frame: 2-3 years
Gastric emptying (T1/2 [min] and retention [%/min])
2-3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleeve characteristics compared between patients with successful and unsuccessful (poor) weight loss
Time Frame: 2-3 years
Volume (sleeve size [mL] and gastric acid [mL])
2-3 years
to assess the association between gastric emptying rate and gastric sleeve characteristics in each group
Time Frame: 2-3 years
association between outcome 1, 2 and 3
2-3 years
to compare subjective ratings of gastric fullness and wellbeing between patients with successful and unsuccessful weight loss
Time Frame: 2-3 years
questionnaires (VAS-scale, MAIA, HADS, EBBS, Power of food scale, and Food tolerance test)
2-3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Collaborators

Wageningen University and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2022

Primary Completion (Actual)

March 30, 2026

Study Completion (Actual)

March 30, 2026

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-1690

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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