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

Recruiting now · Not applicable

Conditions studied: Bariatric Surgery, Weight Loss, Comorbidities and Coexisting Conditions

In brief

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.

Key facts

Study ID

NCT05472922

Run by

Marc van Det

People needed

210

Starts

2022-07-01

Expected to finish

2028-07-01

Last updated by the study team

2022-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Ziekenhuisgroep Twente — Almelo, Netherlands (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.