Laparoscopic Gastric Bypass:
Common Channel trial

Rationale: Morbid obesity 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-en-Y Gastric Bypass (LRYGB) is considered to
be the most effective bariatric treatment option for morbid obesity as it
results in adequate weight loss and a significant decrease in comorbidity.
Although this technique has been applied for years now, the optimal lengths of
the three bowel limbs (alimentary limb (AL), biliopancreatic limb (BL) and
common channel (CC)) in order to achieve maximal percentage extra weight loss
(%EWL) with minimal side effects such as malabsorption symptoms, are unknown.
As `normal` sized bypasses achieve 60% EWL after one year on average (i.e.
still 40% body overweight remaining), one could hypothesize that afferent limb
lengths should be longer in order to reduce the common channel length, thereby
enhancing the %EWL. Such long limb bypasses have been described in
retrospective series and small randomized controlled trials (RCT) with improved
%EWL results, without increasing malabsorbtion, although these results were
only applicable to the selected group of superobese patients. Nevertheless,
most of the investigators of these studies suggest that the length of the
common channel could be an important parameter for achieving optimal %EWL
following LRYGB. The aim of the current study is to investigate the role of the
common channel in LRYGB surgery for morbid obesity.
In this RCT distal LRYGB (with 60cm BL and fixed 100cm CC, thus variable AL)
will be compared to standard LRYGB, (fixed 150cm AL and 60cm BL, thus variable
CC), in order to define which option is the most effective therapeutic strategy
in the morbid obese patient (BMI 40-60 kg/m2) in terms of %EWL after one year.

Objective:
The primary objective is to evaluate whether distal LRYGB (DLRYGB) is superior
in terms of %EWL after one year follow-up compared to standard LRYGB (LRYGB).
Secondary objectives are to evaluate effect on quality-of-life (QOL), cure
/improvement of obesity related co-morbidity (i.e. DM-2, hypertension,
hypercholesterolemia, Obstructive Sleep Apnoea Syndrome (OSAS)), complications,
malnutrition side effects, re-admission rate, and re-operation rate.

A randomized controlled, open-label, trial comparing bariatric surgery in the
morbid obese patient by either DLRYGB with a fixed common channel length of
100cm or standard LRYGB with a variable common channel length.

distal LRYGB

Distal LRYGB is considered to be a different approach to standard LRYGB but
with minimal technical burdens. Potential malnutrition (that may be induced by
a short common channel) will be encountered in an early phase by frequent
check-up in standardized follow-up visits, which are also routinely performed
in standard LRYGB patients. Laboratory tests such as vitamin and iron status
are part of the standard follow-up for patients after surgery for morbid
obesity. The only difference compared to non participants is that patients have
to fill out three QOL-questionnaires on admission and after 12, 36, 60 months.
Therefore, the additional burden for participants is considered to be minimal.