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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2028-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Bariatric Surgery Weight Loss Comorbidities and Coexisting Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Non-blinded prospective randomized controlled single center trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Placement of MiniMizer Gastric Ring

Intervention Type DEVICE

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

non-Banded Mini Gastric Bypass

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

Group Type ACTIVE_COMPARATOR

Normal MGB-OAGB

Intervention Type PROCEDURE

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

Interventions

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Placement of MiniMizer Gastric Ring

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

Intervention Type DEVICE

Normal MGB-OAGB

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No