Clinical trial NCT05472922: The Banded Mini Gastric Bypass Trial: A Prospective Randomized Controlled Trial
Official title: The Banded Mini Gastric Bypass Trial: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bariatric Surgery
Weight Loss
Comorbidities and Coexisting Conditions
Keywords: MGB-OAGB
MiniMizer Ring
banded bypass
Lead sponsor: Ziekenhuisgroep Twente
Sponsor class: OTHER
Collaborators: name: Ziekenhuisgroep Twente
First posted: 2022-07-25
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-blinded prospective randomized controlled single center trial.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Total Body Weight Change 5 years after surgery
timeFrame: 5 Years
Secondary outcomes:
measure: Change in Percentage Excess Weight (%EWL) 5 years after surgery
timeFrame: 5 years
measure: Change in (existing) co-morbidities 5 years after surgery
timeFrame: 5 years
measure: Outcome measurement of SF-36 questionnaire
timeFrame: 5 years
measure: Outcome measurement of OBESI-Q questionnaire
timeFrame: 5 years
measure: Dumping Syndrome
timeFrame: 5 years
measure: Complications
timeFrame: 5 years
Other outcomes:
Locations:
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twente
Study officials:
affiliation: ZiekenhuisGroup Twente
name: Marc J van Det, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: