Ring augmented Roux-en-Y Gastric Bypass vs non banded standard Roux-en-Y Gastric Bypass within BMI range of 35 to 55 kg/m²

Ring augmented Roux-en-Y Gastric Bypass vs non banded standard Roux-en-Y Gastric Bypass within BMI range of 35 to 55 kg/m² - RAB-Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00039445

Enrollment

2000

Registered

2026-02-24

Start date

2026-03-13

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Obesity (BMI range of 35 to 55 kg/m²)

Interventions

Group 1: Patients with a medical indication for a Roux-en-Y gastric bypass undergo a Roux-en-Y gastric bypass with ring reinforcement as a metabolic-bariatric procedure. The following parameters are

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: BMI =35kg/m2 plus comorbidities or BMI =40kg/m2 to BMI =55 kg/m2

Exclusion criteria

Exclusion criteria: • any chronic inflammatory or malignant disease • any previous bariatric surgery • type 1 diabetes • peptic ulcer • contraindication for general anaesthesia • drug or alcohol abuse • untreated thyroid dysfunction • pregnancy or breast-feeding woman • expected non-compliance • participation in another interventional trial requiring insurance • Oesophageal Varices • Advanced Liver cirrhosis • Vulnerable persons according to the law • Allergy to silicone

Design outcomes

Primary

Measure	Time frame
%EWL (Percent Excess Weight Loss) after 5 years study visit with clinical examination	—

Secondary

Measure	Time frame
• %TWL (Percent Total Weight Loss) • %EWL and %TWL in different BMI subgroups (low BMI 35 to 45, high BMI 45 to 55) • HbA1c value and diabetes remission rate (for patients with type 2 diabetes) • quality of life • GERD (gastroesophageal reflux disease) and Dumping symptoms • Ring-specific complications • Safety • Usability	—

Countries

Germany

Contacts

Public ContactArne Dietrich

Universitätsklinikum Leipzig

arne.dietrich@medizin.uni-leipzig.de+493419717230

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026