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The banded mini gastric bypass trial

The banded mini gastric bypass trial - RiMini trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51858
Enrollment
210
Registered
2022-05-13
Start date
2022-08-16
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

weight-loss surgery

Interventions

One group receives *standard* Omega Loop Gastric Bypass (OLGB) and one group receives banded OLGB (bOLGB), which means adjustment of a MiniMizer Ring around the gastric pouch.

Sponsors

Ziekenhuisgroep Twente
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients who are eligible for OLGB surgery will be included for this study according the national guidelines for bariatric surgery.

Exclusion criteria

Exclusion criteria: - Bariatric surgery in the past - Patients - Chronical inflammatoiry diseases - Kidney- or liver dysfunction - Pregnancy at the start or during the experiment - Patients with therapeutic resistance in severe clinical complains of reflux - Allergie for silicone

Design outcomes

Primary

MeasureTime frame
%TBWL after 5 years

Secondary

MeasureTime frame
- (%EWL) - Decrease of comorbidities such as diabetes mellitus, hypertension, and hypercholesterolemia - Improvement of quality of life: SF-36 and OBESI-Q questionnaires - Incidence and severity of dumping syndrome -Incidence and severity of reflyx symptoms: GERD-HRQoL questionnaire - Incidence and complications due to silicone band

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)