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CompletedNCT06407193EMRISSUpdated Apr 3, 2026

Gastric Emptying After Sleeve Gastrectomy

An observational study in Gastric Emptying and Bariatric Surgery, sponsored by Rijnstate Hospital. Completed at 1 site in Netherlands. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-04-03.

Sponsored by Rijnstate Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
18
Ages
18 Years to 55 Years
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Gastric Emptying
  • Bariatric Surgery

Keywords

  • Gastric emptying
  • Gastric sleeve
  • MRI
  • Scintigraphy
03

In context

Lead sponsor

Rijnstate Hospital is the lead sponsor of 127 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Women after sleeve gastrectomy with either good or poor weight loss

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
18 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • OtherMRI and scintigraphy

    Gastric emptying measured with MRI and scintigraphy

06

What researchers measure

Primary outcomes

  1. Gastric emptying compared between patients with poor and successful weight loss

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

    Time frame: 2-3 years

  2. Gastric emptying compared between measured with MRI and scintigraphy

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

    Time frame: 2-3 years

Secondary outcomes

  1. Sleeve characteristics compared between patients with successful and unsuccessful (poor) weight loss

    Volume (sleeve size \[mL\] and gastric acid \[mL\])

    Time frame: 2-3 years

  2. to assess the association between gastric emptying rate and gastric sleeve characteristics in each group

    association between outcome 1, 2 and 3

    Time frame: 2-3 years

  3. to compare subjective ratings of gastric fullness and wellbeing between patients with successful and unsuccessful weight loss

    questionnaires (VAS-scale, MAIA, HADS, EBBS, Power of food scale, and Food tolerance test)

    Time frame: 2-3 years

07

Study locations

1 site
  • Rijnstate Hospital
    Arnhem, Gelderland 6815AD, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06407193
Lead sponsor
Rijnstate Hospital
Collaborators
Wageningen University and Research
Responsible party
Sponsor
First posted
May 9, 2024
Start date
May 10, 2022
Primary completion
Mar 30, 2026
Completion
Mar 30, 2026
Last update
Apr 3, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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