Laparoscopic Gastric Bypass Versus Laparoscopic Banded Gastric Bypass Randomized Prospective Clinical Trial

Launched by PUERTA DE HIERRO UNIVERSITY HOSPITAL · Oct 19, 2016

Keywords

ClinConnect Summary

This trial is comparing two ways to perform gastric bypass surgery for people with morbid obesity. One group has the standard laparoscopic Roux-en-Y gastric bypass, and the other group has the same surgery but with a polypropylene mesh band around the stomach pouch to help with weight loss. Participants are randomly assigned to one of the two procedures (more people in the banded group), and the study team does not know which surgery the participant received while you’re in the operating room. The main goals are to look at how much excess weight participants lose up to 10 years after surgery and how often they have surgery-related complications, with additional information on weight loss at 5 years and hospital costs in the first 3 months.

Eligible participants are adults aged 18–65 with a body-mass index (BMI) of 40–55, obesity lasting at least 5 years, and who have tried and not succeeded with supervised weight loss programs. They must understand the surgery and agree to follow the post-surgery plan, including avoiding pregnancy for a year. Exclusion criteria include certain medical conditions such as endocrine obesity, severe mental illness, high anesthetic risk, cancer, inflammatory bowel disease, and severe liver disease. The trial is taking place at Puerta de Hierro University Hospital in Majadahonda, Madrid, Spain, and plans to enroll about 80 people (50 in the banded-gastric-bypass group and 30 in the standard gastric-bypass group). Results are not yet available, and the study is overseen by a data monitoring committee.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • criteria for bariatric surgery published in 1991 for the National Institutes of Health of the USA.
• • Body mass index (BMI)\> 40 and \<55 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
• • Inflammatory bowel disease
• • Severe liver disease
• • Digestive disease that makes unwise the bypass technique (mainly gastric illness that may required upper endoscopy for control)
• • abdominal wall hernias
• • Symptomatic biliary pathology that requires cholechistectomy at the same time of the bariatric surgery
• • any known pathology that requieres or recomend simultaneous surgery at the time of the bariatric surgery.