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OpenTrials
Completed

NCT Number: NCT06407193

Gastric Emptying 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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Rijnstate Hospital

Arnhem, Gelderland, 6815AD, Netherlands

About this study

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.

Who can participate

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

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

Treatment and study plan

MRI and scintigraphy

Other

Gastric emptying measured with MRI and scintigraphy

Primary outcomes

  1. 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. Gastric emptying compared between measured with MRI and scintigraphy

    Time frame: 2-3 years

    Gastric emptying (T1/2 [min] and retention [%/min])

Secondary outcomes

  1. 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. 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

  3. 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)

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Collaborators

  • Wageningen University and Research

Registry information

Official study title

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

Acronym: EMRISS

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 9, 2024
Registry last updated
Apr 3, 2026

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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