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

NCT05472922 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2022-07-25

No results posted yet for this study

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.

Conditions

  • Bariatric Surgery
  • Weight Loss
  • Comorbidities and Coexisting Conditions

Interventions

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

Sponsors & Collaborators

  • Ziekenhuisgroep Twente

    collaborator OTHER

  • Marc van Det

    lead OTHER

Principal Investigators

  • Marc J van Det, MD PhD · ZiekenhuisGroup Twente

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2023-07-01
Completion
2028-07-01

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05472922 on ClinicalTrials.gov