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Bandolera trial: The 'Banded' Gastric Bypass

Bandolera trial: The 'Banded' Gastric Bypass - Bandolera trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44693
Enrollment
130
Registered
2015-06-02
Start date
2015-08-25
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

Group 1:The RYGB is created with a vertical pouch using a 40fr gastric tube (volume 30-50ml), an biliopancreatic limb of 75 cm and alimentary limb of 150cm. Group 2: Same procedure as group 1 adding

Sponsors

Rijnstate Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Fried Guidelines for bariatric surgery:;- age between 18-65 year - BMI >40 kg/m2 without comorbidities - BMI > 35 and

Exclusion criteria

Exclusion criteria: - Fried Guidelines for bariatric surgery - Specific exclusion criteria for this study: previous bariatric surgery, language barrier, genetic disorder which influences medical advice, patients with obesity due to an other disease e.g. Cushing or medication. Chronic bowel disease e.g. M. Crohn or collitis ulcerosa. Renal failure (MDRD

Design outcomes

Primary

MeasureTime frame
Percentage Total Body Weight Loss (%TBWL) after three years.

Secondary

MeasureTime frame
a. Percentage Excess Weight Loss (%EWL), and Body Mass Index (BMI) b. Percentage total body weight regain c. Reduction of co-morbidities due to morbid obesity d. Quality of life: SF-36 en BAROS e. Incidence of dumping syndrome f. Difference in complication rates g. Differences between the two devices: all endpoints written above, operating time and complications, implantation time and the costs.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)