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

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.

Study Overview

• Status: Recruiting
• Conditions: Weight Loss; Bariatric Surgery; Comorbidities and Coexisting Conditions
• Intervention / Treatment: Device: Placement of MiniMizer Gastric Ring; Procedure: Normal MGB-OAGB

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc J van Det, MD PhD; Phone Number: +31887087878; Email: m.vdet@zgt.nl
• Study Contact Backup: Name: Maureen Tissink, MD; Phone Number: +31887087878; Email: m.tissink@zgt.nl

Study Locations

• Netherlands
  • Almelo, Netherlands
    • Recruiting
    • Ziekenhuisgroep Twente
    • Contact: Marc J van Det, MD PhD; Phone Number: +31887087878; Email: m.vdet@zgt.nl
    • Contact: Maureen W Tissik, MD; Phone Number: +31887087878; Email: m.tissink@zgt.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Banded Mini Gastric Bypass; 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; Insertion of MiniMizer Gastric Ring in addition to the normal MGB-OAGB
Active Comparator: non-Banded Mini Gastric Bypass; Patients are treated for morbid obesity with a Mini gastric bypass (MGB-OAGB)	Procedure: Normal MGB-OAGB; No insertion of Minimizer Gastric Ring in addition to the normal MGB-OAGB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Body Weight Change 5 years after surgery	Percentage total body weight change 5 years after the procedure	5 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Percentage Excess Weight (%EWL) 5 years after surgery	Change in Percentage Excess Weight (%EWL)	5 years
Change in (existing) co-morbidities 5 years after surgery	Change in severity of obesity-related co-morbidities: Type 2 Diabetes Mellitus (changes in HbA1c or use of antidiabetic medication), Hypertension (changes in bloodpressure or changes in use of antihypertensives), Osteo-arthritis (changes in VAS-score or use of analgesia drugs) , Hyperlipidemia (changes in HDL/LDL ratio, triglycerides or use of statine drugs), Obstructive Sleep Apnea syndrome (changes in use of CPEP treatment or changes is apneu hypopneu idex), and Gastro-Esophageal Reflux Disease (Changes in outcomes of GERD-HR questionnnaire which scoring scale runs from 0 (asymptomatic) to 50 (complete prohibitive) or changes in use of protonpompinhibitors)	5 years
Outcome measurement of SF-36 questionnaire	Evalution of changes in outcome of SF-36 Questionnaire 5 years after surgery. Scoring scale is described between 0 (lowest) and 100 (highest) to evaluate patient's welfare	5 years
Outcome measurement of OBESI-Q questionnaire	Evalution of changes in outcome of OBESI-Q Questionnaire 5 years after surgery. Scoring scale is described between 0 (lowest) and 100 (highest) to evaluate patient's welfare	5 years
Dumping Syndrome	The presence and severity of complains related to Dumping Syndrome in participants (yes or no)	5 years
Complications	The occurrence of short- and long-term complications of the minimizer ring	5 years

Collaborators and Investigators

• Sponsor: Marc van Det
• Collaborators: Ziekenhuisgroep Twente
• Investigators: Principal Investigator: Marc J van Det, MD PhD, ZiekenhuisGroup Twente

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2028

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: MGB-OAGB; MiniMizer Ring; banded bypass
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: R22.025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual Participant data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No