Gastric Emptying After Sleeve Gastrectomy

NCT ID: NCT06407193

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-10

Study Completion Date

2025-05-31

Brief Summary

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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

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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.

Conditions

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Gastric Emptying Bariatric Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Poor weight loss group

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

MRI and scintigraphy

Intervention Type OTHER

Gastric emptying measured with MRI and scintigraphy

Successful weight loss group

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

MRI and scintigraphy

Intervention Type OTHER

Gastric emptying measured with MRI and scintigraphy

Interventions

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MRI and scintigraphy

Gastric emptying measured with MRI and scintigraphy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wageningen University and Research

OTHER

Sponsor Role collaborator

Rijnstate Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Veerbeek

Role: CONTACT

+31 880052115

Facility Contacts

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Veerbeek

Role: primary

+31 880052115

Other Identifiers

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2020-1690

Identifier Type: -

Identifier Source: org_study_id

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