This study aims to compare outcomes between ring augmented RYGB (RaRYGB) using the MiniMizer and standard RYGB without a ring.
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
- Medical device
N.a.
Outcome measures
Primary outcome
<p>The primary endpoint is the percentage of total weight loss (%TWL) after 1 year.</p>
Secondary outcome
<p>Secondary endpoints include %TWL at 2 and 5 years, the reduction of comorbidities, complications in general and specifically related to the MiniMizer, rates of revisional surgery, patient satisfaction, quality of life (QoL), and cost-effectiveness. It is anticipated that RaRYGB will result in higher %TWL at 1, 1.5, 2, 5 and 10 years, a lower rate of recurrent weight gain, reduced need for revisional surgery, and improved cost-effectiveness compared to standard RYGB.</p>
Background summary
Overweight (BMI >25) and obesity (BMI >30) are increasing worldwide, leading to health issues such as type 2 diabetes and cardiovascular diseases. Bariatric Metabolic Surgery (BMS), including Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG), is the most effective treatment, achieving significant weight loss and improvement in comorbidities. However, maintaining long-term weight loss remains challenging, as many patients experience recurrent weight gain, which can worsen health problems. A potential innovation to prevent this is the use of a ring, such as the MiniMizer, around the gastric pouch, which may improve weight maintenance.
Study objective
This study aims to compare outcomes between ring augmented RYGB (RaRYGB) using the MiniMizer and standard RYGB without a ring.
Study design
This will be a prospective, single-blind randomized controlled trial (RCT). We will include patients aged 18 to 75 years undergoing primary RYGB. A total of 262 patients will be enrolled in the study.
Intervention
Patients undergoing RYGB surgery will be recruited and randomly assigned to one of two groups: RaRYGB or standard RYGB.
Study burden and risks
Participation in this study imposes no additional burden, as there will be no extra consultations outside of routine care. There will be annual questionnaires, which require 10-15 min to fill in. While ring-related complications may occur, these are expected to be minimal. The RaRYGB is already performed in clinical practice, and no significant rise in complications is anticipated.
E.G. Boerma
Henri Dunantstraat 5
Heerlen 6419 PC
Netherlands
088-4599719
secretariaatheelkunde@zuyderland.nl
E.G. Boerma
Henri Dunantstraat 5
Heerlen 6419 PC
Netherlands
088-4599719
secretariaatheelkunde@zuyderland.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
- Men and women > 18 years and < 65 years old
- Primary Roux-en-Y Gastric Bypass
- Eligible for questionnaires
- Sufficient understanding of the Dutch written language (reading and writing)
- Obtained written informed consent
Exclusion criteria
- BMI > 60
- Previous bariatric surgery
- Contra-indications for usage of the MiniMizer
- Allergy to silicone
- Auto-immune connective tissue disease (e.g. Lupus, scleroderma)
- Crohn’s disease
- Risk of potential bleeding in the upper gastrointestinal tract (e.g. esophageal or gastric varices) or congenital/acquired telangiectasia
- Congenital or acquired abnormalities of the gastrointestinal tract (e.g. atresia or stenosis)
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Research portal | NL-009404 |