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

Weight Loss Clinical Trial

— RiMini  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05472922
• Other study ID #: R22.025
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: July 1, 2028

Study information

• Verified date: July 2022
• Source: Ziekenhuisgroep Twente
• Contact: Marc J van Det, MD PhD
• Phone: +31887087878
• Email: m.vdet[@]zgt.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. %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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: July 1, 2028
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Comorbidities and Coexisting Conditions
• Weight Loss

Intervention

Device:
• Placement of MiniMizer Gastric Ring
Insertion of MiniMizer Gastric Ring in addition to the normal MGB-OAGB

Procedure:
• Normal MGB-OAGB
No insertion of Minimizer Gastric Ring in addition to the normal MGB-OAGB

Locations

Country	Name	City	State
Netherlands	Ziekenhuisgroep Twente	Almelo

Sponsors (2)

Lead Sponsor	Collaborator
Marc van Det	Ziekenhuisgroep Twente

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Body Weight Change 5 years after surgery	Percentage total body weight change 5 years after the procedure	5 Years
Secondary	Change in Percentage Excess Weight (%EWL) 5 years after surgery	Change in Percentage Excess Weight (%EWL)	5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Dumping Syndrome	The presence and severity of complains related to Dumping Syndrome in participants (yes or no)	5 years
Secondary	Complications	The occurrence of short- and long-term complications of the minimizer ring	5 years