Clinical trial NCT02779322: Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic One Anastomosis Gastric Bypass
Official title: Prospective Randomized Controlled Clinical Trial: Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic One Anastomosis Gastric Bypass
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morbid Obesity
Postoperative Complications
Weight Loss
Keywords: gastric bypass
hospital charges
mini gastric bypass
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* criteria for bariatric surgery published in 1991 for the National Institutes of Health of the USA.
* age between 18-65 years-old.
* BMI between 40-50 kg/m2
* Obesity for more than 5 years of evolution
* Fail in medical supervised weight loss program
* patient knowing of the mechanism of weight loss after surgery and agreement to collaborate with medical recommendations, diet, medical treatment, as well as the visit established in the follow up program
* patient accepting that surgery objective is not to achieve the ideal weight.
* signed specific informed consent
* women will agree in avoid gestation during one year after surgery

Exclusion Criteria:

* Patients unable to sign the informed consent form because of a mental disorder.
* endocrine diseases causing obesity
* unstable mental disorder, evaluated for a psychiatry MD.
* high anesthetic risk making surgery too risky.
* Malignant neoplasm
* Gastroesophageal reflux disease (GERD) with endoscopic esophagitis

Primary outcomes:
measure: Hospital Cost in euros
timeFrame: up to 3 months
measure: Length of operation in minutes
timeFrame: 1 day
Secondary outcomes:
measure: weight loss in kilograms
timeFrame: 3 months
measure: weight loss in kilograms
timeFrame: 6 months
measure: weight loss in kilograms
timeFrame: 9 months
measure: weight loss in kilograms
timeFrame: 12 months
measure: weight loss in kilograms
timeFrame: 18 months
measure: weight loss in kilograms
timeFrame: 24 months
measure: weight loss in kilograms
timeFrame: 3 years
measure: weight loss in kilograms
timeFrame: 4 years
measure: weight loss in kilograms
timeFrame: 5 years
Other outcomes:
measure: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
timeFrame: through study completion an average of 5 year
Locations:
city: Majadahonda
country: Spain
facility: Servicio de Cirugía General. Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
Study officials:
affiliation: Unidad Cirugia Obesidad y Metabolica Hospital Puerta de Hierro
name: Miguel J Garcia-Oria, MD PhD FACS
role: STUDY_CHAIR
References:
citation: Lee WJ, Ser KH, Lee YC, Tsou JJ, Chen SC, Chen JC. Laparoscopic Roux-en-Y vs. mini-gastric bypass for the treatment of morbid obesity: a 10-year experience. Obes Surg. 2012 Dec;22(12):1827-34. doi: 10.1007/s11695-012-0726-9.
citation: Rutledge R. The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg. 2001 Jun;11(3):276-80. doi: 10.1381/096089201321336584.
citation: Lee WJ, Yu PJ, Wang W, Chen TC, Wei PL, Huang MT. Laparoscopic Roux-en-Y versus mini-gastric bypass for the treatment of morbid obesity: a prospective randomized controlled clinical trial. Ann Surg. 2005 Jul;242(1):20-8. doi: 10.1097/01.sla.0000167762.46568.98.
citation: Lee WJ, Lin YH. Single-anastomosis gastric bypass (SAGB): appraisal of clinical evidence. Obes Surg. 2014 Oct;24(10):1749-56. doi: 10.1007/s11695-014-1369-9.
citation: Piche ME, Auclair A, Harvey J, Marceau S, Poirier P. How to choose and use bariatric surgery in 2015. Can J Cardiol. 2015 Feb;31(2):153-66. doi: 10.1016/j.cjca.2014.12.014. Epub 2014 Dec 15.
citation: Ramos AC, Silva AC, Ramos MG, Canseco EG, Galvao-Neto Mdos P, Menezes Mde A, Galvao TD, Bastos EL. Simplified gastric bypass: 13 years of experience and 12,000 patients operated. Arq Bras Cir Dig. 2014;27 Suppl 1(Suppl 1):2-8. doi: 10.1590/s0102-6720201400s100002.