Ring augmented versus standard gastric bypass: evaluating efficacy and outcomes

Ring augmented vs standard Roux-en-Y Gastric Bypass Evaluating MiniMizer Ring Efficacy and Outcomes: A Randomized Controlled Trial - Ring augmented vs standard Roux-en-Y Gastric Bypass Evaluating MiniMizer Ring Efficacy and Outcomes: A Randomized Controlled Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57518

Enrollment

250

Registered

2025-02-17

Start date

2025-08-26

Completion date

Unknown

Last updated

2025-11-03

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

Conditions

Obesity

Interventions

Patients undergoing RYGB surgery will be recruited and randomly assigned to one of two groups: RaRYGB or standard RYGB.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Men and women > 18 years and < 65 years oldPrimary Roux-en-Y Gastric Bypass  Eligible for questionnaires Sufficient understanding of the Dutch written language (reading and writing) Obtained written informed consent 

Exclusion criteria

Exclusion criteria: BMI > 60 Previous bariatric surgeryContra-indications for usage of the MiniMizer Allergy to silicone Auto-immune connective tissue disease (e.g. Lupus, scleroderma) Crohn’s disease Risk of potential bleeding in the upper gastrointestinal tract (e.g. esophageal or gastric varices) or congenital/acquired telangiectasia Congenital or acquired abnormalities of the gastrointestinal tract (e.g. atresia or stenosis) 

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the percentage of total weight loss (%TWL) after 1 year.	—

Secondary

Measure	Time frame
Secondary endpoints include %TWL at 2 and 5 years, the reduction of comorbidities, complications in general and specifically related to the MiniMizer, rates of revisional surgery, patient satisfaction, quality of life (QoL), and cost-effectiveness. It is anticipated that RaRYGB will result in higher %TWL at 1, 1.5, 2, 5 and 10 years, a lower rate of recurrent weight gain, reduced need for revisional surgery, and improved cost-effectiveness compared to standard RYGB.	—

Measure

Time frame

Secondary endpoints include %TWL at 2 and 5 years, the reduction of comorbidities, complications in general and specifically related to the MiniMizer, rates of revisional surgery, patient satisfaction, quality of life (QoL), and cost-effectiveness. It is anticipated that RaRYGB will result in higher %TWL at 1, 1.5, 2, 5 and 10 years, a lower rate of recurrent weight gain, reduced need for revisional surgery, and improved cost-effectiveness compared to standard RYGB.

—

Countries

Netherlands

Contacts

Public ContactE.G. Boerma

Zuyderland

secretariaatheelkunde@zuyderland.nl088-4599719

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)