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Feasibility study adjustable banded gastric bypass.

Feasibility study adjustable banded gastric bypass. - Banded bypass

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36919
Enrollment
12
Registered
2012-10-29
Start date
2012-11-12
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Morbid obesity

Interventions

Adjustable gastric banding combined with gastric bypass procedure

Sponsors

Atrium Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age 18-65 Years - BMI * 35 with co-morbidity or BMI * 40 - Signed informed consent - Approval by the multidisciplinary team

Exclusion criteria

Exclusion criteria: -History of obesity surgery -History of major abdominal surgery with consecutive malabsorption (no restrictions of the stomach, small and large bowel (exception appendectomy) -Patients not eligible to implement the adjustable band - History of/or present alcohol or drug abuse - History of major psychiatric illness conflicting with the patient compliance - History of recent or chronic steroid medication - Autoimmune disease - Inflammatory bowel disease or malabsorptive disease - Liver cirrhosis (CHILD B + C) - Active viral or bacterial disease (HIV, Hepetitis B or C, Tbc etc) - Pregnancy - History of cancer in the last 5 years - Need of long term anticoagulant medication for any reason

Design outcomes

Primary

MeasureTime frame
Primary: similar or less complication rate of short term complications of a standard Roux- and Y gastric bypass and similar or less percentages of band erosion.

Secondary

MeasureTime frame
Secondary: similar or more excess weight loss compared to RYGB.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)