Gastric Emptying After Sleeve Gastrectomy (EMRISS)

Rijnstate Hospital

Status: Enrolling

Conditions: Gastric Emptying; Bariatric Surgery

Treatments: Other: MRI and scintigraphy

Study type: Observational

Funder types: Other

Identifiers

NCT06407193

2020-1690

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

6 participants in 2 patient groups

Poor weight loss group

Description:

Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with TWL \< 25%

Treatment:

Other: MRI and scintigraphy

Successful weight loss group

Description:

Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with TWL \> 35%

Treatment:

Other: MRI and scintigraphy