TAiloring LImb length based on total small bowel Lengthin Omega-loop gastric bypass suRgery : the TAILOR study

Recruiting

Conditions: <p>class III obesity or class II with co-morbidities e.g diabetes, hypertension, sleep apnea, arthrosis</p>

Registration Number: NL-OMON27559

Lead Sponsor: Medisch Center Leeuwarden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 212

Inclusion Criteria

Agreed to have mini-gastric bypass surgery
- Age between 18 and 65
-BMI > 40 kg/m2 or
-BMI > 35 kg/m2 with co-morbidity : diabetes, hypertension, OSAS, arthrosis
-Willing to participate with written informed consent before start of the surgery
-A completely measured total small bowel during surgery
-No pre-operative deficiencies of vit B12, vit D and iron, measured with ferritin
-No use of extra (multi-)vitamin supplements with exception of vit D max 800 IU/day
-Able to swallow the multivitamin FFM WLS primo (tested before surgery)

Exclusion Criteria

-BMI > 50 Kg/m2
-Known gastro-intestinal disease or history of gastro-intestinal disease, e.g. celiac disease, inflammatory bowel disease
-Known addiction behaviour
-Suspected compliance problems
-Intolerance to Fitforme Primo multivitamin
-Pregnancy planning within the first two years after surgery
-Renal or hepatic insufficiency
-Former abdominal surgery unabling the measurement of the small bowel during laparoscopic surgery
-Parenteral use of vit B12

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percent total weight loss (%TWL) at 5 years. Assumptions : Control group : TWL of 35% (SD 12%) Experimental group : TWL of 40% (SD 12 or 9%) (Absolute difference TWL 5% with possible smaller SD) Definition : TWL = ([initial weight – attained weight]/ initial weight) * 100</p>

Secondary Outcome Measures