Study protocol of the DUCATI-study: a randomized controlled trial investigating the optimal common channel length in laparoscopic gastric bypass for morbid XXXX @entity1 .

@entity1 @entity353 @entity28 @entity4218 @entity3147
BACKGROUND: Morbid @entity28 has become one of the most frequent chronic medical disorders in Western countries, affecting 1.5-2  % of the Dutch population. Currently, the laparoscopic Roux-Y gastric bypass is considered to be the most effective bariatric treatment option for morbid @entity28 as it results in adequate @entity353 and a significant decrease in comorbidity. Although this technique has been applied for years, the optimal lengths of the three bowel limbs ( @entity4218 , biliopancreatic limb, and common channel) in order to achieve maximal percentage excess @entity353 with minimal side effects (i.e. malabsorption symptoms), are unknown. As 'normal' sized gastric bypasses achieve an average of 60   -   80  % excess @entity353 after one year, one could hypothesize that afferent limb lengths should be longer in order to reduce the common channel length, thereby improving outcome in terms of excess @entity353 . The aim of the current study is to investigate the effect of the length of the common channel in gastric bypass surgery for morbid @entity28 . In this randomized controlled trial the very long Roux limb gastric bypass will be compared to the standard gastric bypass, in order to conclude which option is the optimal therapeutic strategy in the morbidly @entity28 @entity1 . METHODS/DESIGN: In this multicentre trial @entity1 will be randomized either to a very long Roux limb gastric bypass with a fixed common channel length of 100  cm, or to a standard gastric bypass with a variable common channel length. The primary objective is to evaluate whether the very long Roux limb gastric bypass is superior in terms of percentage excess @entity353 after one year follow-up compared to the standard gastric bypass. Secondary endpoints are quality-of-life, cure /improvement of @entity28 related comorbidity, complications, @entity3147 , re-admission rate, and re-operation rate. DISCUSSION: We hypothesize that our proposed distal LRYGB will provide for improved results concerning % EWL with an acceptable rate of (metabolic) complications. Our main point of interest is to determine if the distal LRYGB is a superior alternative to standard LRYGB in terms of percentage excess @entity353 and to put more focus on the role of the common channel. Therefore we will perform this randomized controlled trial comparing both techniques, with % EWL as a primary outcome. TRIAL REGISTRATION: CCMO registration number: NL43951.101.13 and Netherlands Trial Registry number: NTR4466.
