The Gallbladder Function after Gastric Bypass Surgery - Trial

The Gallbladder Function after Gastric Bypass Surgery - Trial - The FUGA Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40635

Enrollment

Registered

2014-07-29

Start date

2015-03-26

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cholecystolithiasis gallstones

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Eligible patients meet the current bariatric surgery criteria used in our clinic, in accordance with IFSO criteria. The age of the patient is 18-65 years. BMI >= 40 kg/m2 or BMI >=35 kg/m2; with serious comorbidities related to obesity such as diabetes mellitus, OSAS and arthrosis.

Exclusion criteria

Exclusion criteria: -Patients with previous (laparoscopic) cholecystectomy will be excluded. -Patients with presenting with biliary symptoms or gallstones at time of RYGB will be excluded. -Patients with a different intervention than a Roux-en-Y Gastric Bypass will be excluded (eg. Gastric sleeve, gastric band, etc.) -Ursodeoxycholic acid usage.

Design outcomes

Primary

Measure	Time frame
Ultrasonography measured gallbladder functions after RYGB. Gallbladder function is assessed using the measurement of ejection fraction, residual volume and fasting volume after an overnight fast.	—

Secondary

Measure	Time frame
Secondary study parameters/endpoints (if applicable) 1. Incidence of biliary symptoms 2. Incidence of bile sludge 3. Incidence of symptomatic cholecystolithiasis 4. Serum cholecystokinin levels Other study parameters Patient characteristics: - Age - Gender - Ethnicity - Comorbidities - BMI - Weight loss - Excess weight loss	—

Countries

Netherlands

Outcome results