Gastric Emptying After Sleeve Gastrectomy
- Conditions
- Bariatric SurgeryGastric Emptying
- Interventions
- Other: MRI and scintigraphy
- Registration Number
- NCT06407193
- Lead Sponsor
- Rijnstate Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 6
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Successful weight loss group MRI and scintigraphy Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with TWL \> 35% Poor weight loss group MRI and scintigraphy Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with TWL \< 25%
- Primary Outcome Measures
Name Time Method Gastric emptying compared between patients with poor and successful weight loss 2-3 years Gastric emptying (T1/2 \[min\] and retention \[%/min\])
Gastric emptying compared between measured with MRI and scintigraphy 2-3 years Gastric emptying (T1/2 \[min\] and retention \[%/min\])
- Secondary Outcome Measures
Name Time Method to compare subjective ratings of gastric fullness and wellbeing between patients with successful and unsuccessful weight loss 2-3 years questionnaires (VAS-scale, MAIA, HADS, EBBS, Power of food scale, and Food tolerance test)
to assess the association between gastric emptying rate and gastric sleeve characteristics in each group 2-3 years association between outcome 1, 2 and 3
Sleeve characteristics compared between patients with successful and unsuccessful (poor) weight loss 2-3 years Volume (sleeve size \[mL\] and gastric acid \[mL\])
Trial Locations
- Locations (1)
Rijnstate Hospital
🇳🇱Arnhem, Gelderland, Netherlands