Clinical trial NCT06407193: Gastric Emptying After Sleeve Gastrectomy
Official title: Gastric Emptying Measured With MRI and Scintigraphy in Patients With Successful Versus Unsuccessful Weight Loss After Sleeve Gastrectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Emptying
Bariatric Surgery
Keywords: Gastric emptying
Gastric sleeve
MRI
Scintigraphy
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: Wageningen University and Research
First posted: 2024-05-09
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women after sleeve gastrectomy with either good or poor weight loss

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gastric emptying compared between patients with poor and successful weight loss
timeFrame: 2-3 years
measure: Gastric emptying compared between measured with MRI and scintigraphy
timeFrame: 2-3 years
Secondary outcomes:
measure: Sleeve characteristics compared between patients with successful and unsuccessful (poor) weight loss
timeFrame: 2-3 years
measure: to assess the association between gastric emptying rate and gastric sleeve characteristics in each group
timeFrame: 2-3 years
measure: to compare subjective ratings of gastric fullness and wellbeing between patients with successful and unsuccessful weight loss
timeFrame: 2-3 years
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
Study officials:
References: