Gastric Emptying After Sleeve Gastrectomy

Bariatric Surgery Clinical Trial

— EMRISS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06407193
• Other study ID #: 2020-1690
• Status: Recruiting
• Start date: May 10, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: Rijnstate Hospital
• Contact: Veerbeek
• Phone: +31 880052115
• Email: tveerbeek[@]rijnstate.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: May 31, 2025
• Est. primary completion date: December 31, 2024
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Gastric Emptying

Intervention

Other:
• MRI and scintigraphy
Gastric emptying measured with MRI and scintigraphy

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Rijnstate Hospital	Wageningen University and Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric emptying compared between patients with poor and successful weight loss	Gastric emptying (T1/2 [min] and retention [%/min])	2-3 years
Primary	Gastric emptying compared between measured with MRI and scintigraphy	Gastric emptying (T1/2 [min] and retention [%/min])	2-3 years
Secondary	Sleeve characteristics compared between patients with successful and unsuccessful (poor) weight loss	Volume (sleeve size [mL] and gastric acid [mL])	2-3 years
Secondary	to assess the association between gastric emptying rate and gastric sleeve characteristics in each group	association between outcome 1, 2 and 3	2-3 years
Secondary	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)	2-3 years