The Banded Mini Gastric Bypass Trial: A Prospective Randomized Controlled Trial

NCT05472922 | Recruiting DMC

• 1 other identifier: R22.025
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Investigate if there is a significant weight reduction expressed in total body weight loss percentage (%TBWL) in patients 5 years after surgery, whom underwent a mini gastric bypass (MGB-OAGB) with addition of the implantation of a MiniMizer Ring. Study design: A prospective non blinded single centre randomized controlled trial. Sudy population: The study population will exist of patients eligible for MGB-OAGB surgery. Patients are invited to participate if Body Mass Index (BMI) ≥ 35kg/m2 with a comorbidity related to morbid obesity, or a BMI exceeding 40kg/m2. Intervention: Insertion of the MiniMizer Ring around the gastric pouch in addition to the 'standard' MGB-OAGB. Main study parameters/endpoints: Primary Objective:

1. 1.%TBWL 5 years after surgery.
2. 2.Percentage Excess Weight Loss (%EWL) 5 years after surgery.
3. 3.Decrease or reduction of comorbidities (diabetes mellitus, hypertension, hyperlipidemia, sleep apnoea, and joint complaints).
4. 4.Improvement of quality of life: SF-36 and OBESI-Q questionnaires.
5. 5.Incidence and severity of dumping syndrome.
6. 6.Incidence and severity of reflux symptoms: GERD-HRQoL questionnaire.
7. 7.Incidence and complications due to silicone band.
8. 8.Increase of weight reduction, and due to that decrease of comorbidities and/or mortality related to overweight.
9. 9.Long term decrease of weight regain.
10. 10.Decrease of incidence of dumping.
11. 11.Band-related complications such as erosion, infection, stenosis, or pouch dilatation.
12. 12.Functional gastro-intestinal complains such as dysphagia and reflux.

Conditions

Bariatric Surgery; Weight Loss; Comorbidities and Coexisting Conditions

Keywords

MGB-OAGB; MiniMizer Ring; banded bypass

Outcome Measures

Primary Outcomes (1)

• Total Body Weight Change 5 years after surgery

  Percentage total body weight change 5 years after the procedure

  5 Years

Secondary Outcomes (6)

• Change in Percentage Excess Weight (%EWL) 5 years after surgery

  5 years

• Change in (existing) co-morbidities 5 years after surgery

  5 years

• Outcome measurement of SF-36 questionnaire

  5 years

• Outcome measurement of OBESI-Q questionnaire

  5 years

• Dumping Syndrome

  5 years

Study Arms (2)

Banded Mini Gastric Bypass

EXPERIMENTAL

Patients are treated for morbid obesity with a Mini gastric bypass (MGB-OAGB) with addition of the implantation of a MiniMizer Gastric Ring (Bariatric Solutions GmbH, Stein am Rhein Switzerland)

Device: Placement of MiniMizer Gastric Ring

non-Banded Mini Gastric Bypass

ACTIVE COMPARATOR

Patients are treated for morbid obesity with a Mini gastric bypass (MGB-OAGB)

Procedure: Normal MGB-OAGB

Interventions

Placement of MiniMizer Gastric Ring DEVICE

Insertion of MiniMizer Gastric Ring in addition to the normal MGB-OAGB

Banded Mini Gastric Bypass

Normal MGB-OAGB PROCEDURE

No insertion of Minimizer Gastric Ring in addition to the normal MGB-OAGB

non-Banded Mini Gastric Bypass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients meet IFSO criteria for Bariatric Surgery
• Age 18 and above

You may not qualify if:

• Previous Bariatric surgery
• Inability to read and understand written information
• Any genetic condition that can hamper the acceptance of medical advice
• chronic bowel disease
• Severe kidney of liver disease
• Pregnancy at the start or during the research period
• Patients with pre-existing therapy refractory GERD
• Patients with an allergy to silicone

Sponsors & Collaborators

• Marc van Det: lead
• Ziekenhuisgroep Twente: collaborator

Study Sites (1)

Ziekenhuisgroep Twente

Almelo, Netherlands

RECRUITING

Related Publications (1)

• Tissink M, Verhagen T, Faneyte I, Hazebroek E, Oost S, Timmerman J, Veldhuis A, van Det M. The Banded One-Anastomosis Gastric Bypass Trial (RiMini Trial): Protocol of a Prospective Single-Center Randomized Controlled Trial. Obes Surg. 2025 May;35(5):1854-1859. doi: 10.1007/s11695-025-07751-6. Epub 2025 Mar 14.

  PMID: 40085187 DERIVED

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc J van Det, MD PhD

  ZiekenhuisGroup Twente

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc J van Det, MD PhD

CONTACT

+31887087878; m.vdet@zgt.nl

Maureen Tissink, MD

CONTACT

+31887087878; m.tissink@zgt.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Model Details: Non-blinded prospective randomized controlled single center trial.

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 25, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)