class III obesity or class II with co-morbidities e.g diabetes, hypertension, sleep apnea, arthrosis
Conditions
Interventions
Patients will be randomly allocated to one of the two treatment arms :
- 1. A standard BP-limb length of 150 cm
- 2. A BP-limb length depending on total small bowel length (TSBL) measured during the s
Sponsors
Medisch Center Leeuwarden
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Percent of total weight loss (%TWL) at 1,2,3,and 4 years. 2) Percent excess weight loss (%EWL) at 1,2,3, 4 and 5 years. Definition: %EWL (Initial Weight – Postop Weight) / (Initial Weight – Ideal Weight) (ideal weight is defined by the weight corresponding to a BMI of 25 kg/m2 ) 3) Percent excess BMI loss (%EBMIL) at 1,2,3, 4 and 5 years. Definition: %EBMIL (?BMI / (Initial BMI – 25)) * 100] 4) Proportion of patients with 22 = BMI = 30 Kg/m2 at 1,2,3, 4 and 5 years 5) Mean number of daily bowel movements in the last two weeks at 6 months, 1,2,3, 4 and 5 years. 6) Mean number of days with daily bowel movements > 3 in the last two weeks at 6 months, 1,2,3, 4 and 5 years. 7) Quality of life measured by the RAND-36 questionnaire at 6 months, 1,2,3, 4 and 5 years. 8) percentage of patients experiencing moderate to severe dumping symptoms defined by the Dumping Severity Score (DSS) at 6 months, 1,2,3, 4 and 5 years. Moderate to severe is defined as 3 or more dumping symptoms with a severity score of 2 or 3 on a 4-point Likert scale. Symptoms are divided in two categories, e.g. early and late,as described by Emous et.al. (7) 9) percentage of patients who have neither deficiencies of iron, nor vit. D, nor vit B12 without extra suppletion, at 6 months, 1,2,3, 4 and 5 years . Deficiencies are based on the local normal laboratory values. 10) Proportion of patients who have a deficiency at 6 months, 1,2,3, 4 and 5 years, or received extra suppletion for: - iron (ferritin) - vitamin B12 - vitamin D3 - Vitamin B1 - Vitamin B6 - Folic acid - Vitamin A - Vitamin D - Calcium - Phosphate - Albumin - Zinc - Copper - Selenium 11)Proportion of patients at 1,2,3, 4 and 5 years without diabetes, both with remission and without de novo, defined as an HbA1c less than 48 mmol/mol without diabetes medication in the last 6 months. 12)Proportion of patients at one year and two years with improvement of diabetes, defined as a reduction of HbA1c of 10mmol/mol or more but not reaching remiss | — |
Contacts
Public ContactLoek de Heide
Medisch Centrum Leeuwarden
Outcome results
None listed