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

Rationale:
One-anastomosis gastric bypass/Mini-GB (OAGB/MGB) surgery aims to reduce weight in obese patients to a healthy BMI. Surgeons usually creat a standard length of the biliopancreatic limb (BP-limb) based on own experience. This practice leads in a substantially percentage of patients to either persisting obesity or underweigth. Furthermore, a substantially percentage of patients develop disturbing diarhea and vitamin and mineral deficiencies. The total small bowel length (TSBL) varies in subjects between less than 5 to more than 10 meters. This variance could have consequenses both for weight loss and for deficiencies after OAGB. The aim of the study is to investigate whether adjusting the length of the BP-limb tot the TSBL leads to more weight loss with smaller variance and to less bowel movements and less deficiencies of vitamins and minerals using an optimal multivitamin Fitforme WSL primo.
Objective:
Primary :
To compare the percent total weight loss (%TWL) at 5 years between the group with the standard BP-length and the group with a adjusted BP-length.
Secondary :
To compare the proportion of patients with 22 <= BMI <= 30 ,the mean number of daily bowel movements and number of days with daily bowel movements > 3 over in the last two weeks before a visit, Quality of life measured by the RAND-36 questionnaire between the groups and the percentage of patients experiencing moderate to severe dumping symptoms defined by the Dumping Severity Score (DSS) between the groups.
To compare the proportion of patients in the two groups who have neither deficiencies of iron, nor vit. D, nor vit B12 without extra suppletion, during the study
Study design: double blind intervention study
Study population:
patients between 18 and 65 years with obesity class III or II with comorbidity scheduled for OAGB surgery and willing to participate.
Intervention :
MGB : patients will be randomly allocated to either a standard BP-limb of 150 cm or to a BP-limb length based on their TSBL : TSBL < 500 cm : BP-limb : 150 cm ; TSBL 500-700 cm : BP-limb 180 cm ; TSBL > 700 cm : BP-limb : 210 cm.
Main study parameters/endpoints:
Percent total weight loss (%TWL) at 5 years.
Proportion of patients with 22 ≤ BMI ≤ 30 Kg/m2
Mean number of daily bowel movements in the last two weeks
Mean number of days with daily bowel movements > 3 in the last two weeks
Quality of life measured by the RAND-36 questionnaire
Percentage of patients experiencing moderate to severe dumping symptoms defined by the Dumping Severity Score (DSS)
Percentage of patients who have neither deficiencies of iron, nor vit. D, nor vit B12 without extra suppletion

adjusting the length of the biliopancreatic limb in MGB based on total small bowel length will lead to a BMI more within normal range while having less deficiencies of vitamins and minerals and less bowel movements and/or complaints compared to a standard BP-limb length

End of the study : after 5 years, interim evaluation at year 1,2,3,4

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 surgical procedure :
- TSBL : < 500 cm : 150 cm
- TSBL : 500-700 cm : 180 cm
- TSBL : > 700 cm : 210 cm