Feasibility study adjustable banded gastric bypass.

Phase 2

Completed

• Conditions: Morbid obesity; 10003018

• Registration Number: NL-OMON36919
• Lead Sponsor: Atrium Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary: similar or less complication rate of short term complications of a<br /><br>standard Roux- and Y gastric bypass and similar or less percentages of band<br /><br>erosion.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary: similar or more excess weight loss compared to RYGB.</p><br>