Weight Loss Clinical Trial
Official title:
Prospective Randomized Controlled Clinical Trial: Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic One Anastomosis Gastric Bypass
This study try to identify differences in cost, length of operation and results between two
different bariatric surgical techniques, the laparoscopic Roux-en-Y gastric bypass and the
Single anastomosis laparoscopic gastric bypass. The study will be conducted in a Spanish
public health system hospital.
The patients of the trial will have the preoperative studies, hospital treatment during the
admission, postoperative treatment and follow up as any other patient included in the
hospital bariatric surgery program. No new methods are applied other than randomly choose the
surgical technique.
Patients will be randomized in a 1:1 ratio to each group.
One group of patients of the study will have done the simplified laparoscopic gastric bypass,
with a vertical gastric pouch of about 20 ml, a 150 cm Roux-en-Y limb constructed in an
antegastric antecolic fashion, and a biliary limb of 100 cm. Anastomosis will be done with
endoscopic surgical linear stapler, closing the apertures with continuous absorbable running
sutures. The Petersen space and the mesenteric defect will be closed with non-absorbable
sutures.
The other group of patients will have performed the single anastomosis gastric bypass, also
known as the Minigastric bypass (MGB), which have a vertical gastric pouch about 100-150 ml,
and an end to side gastro-jejunal anastomosis at 200 cm from Treitz angle. The anastomosis
will be done with endoscopic surgical linear stapler, closing the aperture with continuous
absorbable running sutures.The Petersen space will be also close with non-absorbable sutures.
The investigators randomly assigned 10 patients to each group, n=20. Considering that one of
the methods is basically the same than the other, but for the Roux-en-Y construction, it is
expected a clear difference in operating room (OR) time, between groups. Fisher Test, will be
used for the statistical analysis, assuming a risk of 0.05 and a statistical power of 90%,
and Mann-Whitney test for quantitative parameters.
Once patients were included in the study, they were randomized in a 1:1 ratio to the
conventional laparoscopic gastric bypass group or the single-anastomosis laparoscopic gastric
bypass (Mini gastric bypass) group and were also blinded to the surgeon until surgery. The
method of randomization was concealed envelopes.
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