Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic One Anastomosis Gastric Bypass

Weight Loss Clinical Trial

— OAGB-vs-LRYGB  

Official title:

Prospective Randomized Controlled Clinical Trial: Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic One Anastomosis Gastric Bypass

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02779322
• Other study ID #: 06082015
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2015
• Est. completion date: June 2025

Study information

• Verified date: April 2020
• Source: Puerta de Hierro University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: June 2025
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid
• Postoperative Complications
• Weight Loss

Intervention

Procedure:
• Minigastric bypass
The patient will be submitted to a minigastric bypass at the time of the operation
• Gastric bypass
In this case a simplified conventional gastric bypass will be performed

Locations

Country	Name	City	State
Spain	Servicio de Cirugía General. Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. Review. — View 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. — View 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. — View Citation

Piché MÈ, 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. Review. — View Citation

Ramos AC, Silva AC, Ramos MG, Canseco EG, Galvão-Neto Mdos P, Menezes Mde A, Galvão TD, Bastos EL. Simplified gastric bypass: 13 years of experience and 12,000 patients operated. Arq Bras Cir Dig. 2014;27 Suppl 1:2-8. English, Portuguese. — View Citation

Rutledge R. The mini-gastric bypass: experience with the first 1,274 cases. Obes Surg. 2001 Jun;11(3):276-80. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Hospital Cost in euros	Total hospital expenses during admission for the surgery	up to 3 months
Primary	Length of operation in minutes	Duration of the surgical procedure	1 day
Secondary	weight loss in kilograms	weight of the patient at clinics, 3 months after surgery	3 months
Secondary	weight loss in kilograms	weight of the patient at clinics, 6 months after surgery	6 months
Secondary	weight loss in kilograms	weight of the patient at clinics, 9 months after surgery	9 months
Secondary	weight loss in kilograms	weight of the patient at clinics, 12 months after surgery	12 months
Secondary	weight loss in kilograms	weight of the patient at clinics, 18 months after surgery	18 months
Secondary	weight loss in kilograms	weight of the patient at clinics, 24 months after surgery	24 months
Secondary	weight loss in kilograms	weight of the patient at clinics, 3 years after surgery	3 years
Secondary	weight loss in kilograms	weight of the patient at clinics, 4 years after surgery	4 years
Secondary	weight loss in kilograms	weight of the patient at clinics, 5 years after surgery	5 years