Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic One Anastomosis Gastric Bypass (OAGB-vs-LRYGB)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Postoperative Complications; Weight Loss; Morbid Obesity
• Intervention / Treatment: Procedure: Minigastric bypass; Procedure: Gastric bypass

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Servicio de Cirugía General. Hospital Universitario Puerta de Hierro Majadahonda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Minigastric bypass; Intervention(s): The patient will have done a Laparoscopic one anastomosis gastric bypass (minigastric bypass) at the time of the surgical procedure.	Procedure: Minigastric bypass; The patient will be submitted to a minigastric bypass at the time of the operation; Other Names: Single or One anastomosis gastric bypass
Active Comparator: Gastric bypass; The patient will have a Laparoscopic Roux-en-Y gastric bypass at the time of the surgical procedure	Procedure: Gastric bypass; In this case a simplified conventional gastric bypass will be performed; Other Names: Laparoscopic gastric bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Cost in euros	Total hospital expenses during admission for the surgery	up to 3 months
Length of operation in minutes	Duration of the surgical procedure	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight loss in kilograms	weight of the patient at clinics, 3 months after surgery	3 months
weight loss in kilograms	weight of the patient at clinics, 6 months after surgery	6 months
weight loss in kilograms	weight of the patient at clinics, 9 months after surgery	9 months
weight loss in kilograms	weight of the patient at clinics, 12 months after surgery	12 months
weight loss in kilograms	weight of the patient at clinics, 18 months after surgery	18 months
weight loss in kilograms	weight of the patient at clinics, 24 months after surgery	24 months
weight loss in kilograms	weight of the patient at clinics, 3 years after surgery	3 years
weight loss in kilograms	weight of the patient at clinics, 4 years after surgery	4 years
weight loss in kilograms	weight of the patient at clinics, 5 years after surgery	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment	Record of any adverse event and/or abnormal laboratory values in relation with the operation performed since the day of the operation to the study completion.	through study completion an average of 5 year

Collaborators and Investigators

• Sponsor: Puerta de Hierro University Hospital
• Investigators: Study Chair: Miguel J Garcia-Oria, MD PhD FACS, Unidad Cirugia Obesidad y Metabolica Hospital Puerta de Hierro

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): November 1, 2019
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: May 16, 2016
• First Submitted That Met QC Criteria: May 19, 2016
• First Posted (Estimate): May 20, 2016

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 18, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: gastric bypass; hospital charges; mini gastric bypass
• Additional Relevant MeSH Terms: Pathologic Processes; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss; Obesity, Morbid; Postoperative Complications
• Other Study ID Numbers: 06082015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The plan is to publish the results of our study in a scientific journal when it be completed, not to publish the individual patient data, just the global data comparing both groups of study.