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

NCT ID: NCT02779322

Last Updated: 2020-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2025-06-30

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.

Conditions

Morbid Obesity; Postoperative Complications; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Minigastric bypass

Intervention(s): The patient will have done a Laparoscopic one anastomosis gastric bypass (minigastric bypass) at the time of the surgical procedure.

Group Type: ACTIVE_COMPARATOR

Minigastric bypass

Intervention Type: PROCEDURE

The patient will be submitted to a minigastric bypass at the time of the operation

Gastric bypass

The patient will have a Laparoscopic Roux-en-Y gastric bypass at the time of the surgical procedure

Group Type: ACTIVE_COMPARATOR

Gastric bypass

Intervention Type: PROCEDURE

In this case a simplified conventional gastric bypass will be performed

Interventions

Minigastric bypass

The patient will be submitted to a minigastric bypass at the time of the operation

Intervention Type: PROCEDURE

Gastric bypass

In this case a simplified conventional gastric bypass will be performed

Intervention Type: PROCEDURE

Other Intervention Names

Single or One anastomosis gastric bypass; Laparoscopic gastric bypass

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Puerta de Hierro University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Miguel J. Garcia-Oria

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miguel J Garcia-Oria, MD PhD FACS

Role: STUDY_CHAIR

Unidad Cirugia Obesidad y Metabolica Hospital Puerta de Hierro

Locations

Servicio de Cirugía General. Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 23011462 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11433900 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15973097 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25056233 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25661550 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25409956 (View on PubMed)

Other Identifiers

06082015

Identifier Type: -

Identifier Source: org_study_id