The Banded Mini Gastric Bypass Trial: A Prospective Randomized Controlled Trial (RiMini)

Marc van Det

Status: Enrolling

Conditions: Weight Loss; Bariatric Surgery; Comorbidities and Coexisting Conditions

Treatments: Device: Placement of MiniMizer Gastric Ring; Procedure: Normal MGB-OAGB

Study type: Interventional

Funder types: Other

Identifiers

NCT05472922

R22.025

Details and patient eligibility

About

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. %TBWL 5 years after surgery.

   Secondary Objectives:

2. Percentage Excess Weight Loss (%EWL) 5 years after surgery.

3. Decrease or reduction of comorbidities (diabetes mellitus, hypertension, hyperlipidemia, sleep apnoea, and joint complaints).

4. Improvement of quality of life: SF-36 and OBESI-Q questionnaires.

5. Incidence and severity of dumping syndrome.

6. Incidence and severity of reflux symptoms: GERD-HRQoL questionnaire.

7. Incidence and complications due to silicone band.

Measurement of objectives are before surgery and six times after surgery combined with the standard postoperative care for patients who undergo bariatric surgery:

Expected advantages of bOLGB versus OLGB:

1. Increase of weight reduction, and due to that decrease of comorbidities and/or mortality related to overweight.
2. Long term decrease of weight regain.
3. Decrease of incidence of dumping.

Possible disadvantages of bOLGB versus OLGB:

1. Band-related complications such as erosion, infection, stenosis, or pouch dilatation.
2. Functional gastro-intestinal complains such as dysphagia and reflux.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Banded Mini Gastric Bypass

Experimental group

Description:

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)

Treatment:

Device: Placement of MiniMizer Gastric Ring

non-Banded Mini Gastric Bypass

Active Comparator group

Description:

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

Treatment:

Procedure: Normal MGB-OAGB