Banded Versus Conventional Laparoscopic Roux-en-Y (GABY)

ClinTrio Ltd.384 enrolled

Overview

Banded Versus Conventional Laparoscopic Roux-en-Y Gastric Bypass (GABY). The aim of this novel study is to evaluate, if an additional restrictive silastic ring can avoid dilation of the gastro-entero anastomosis and adjacent small bowel with consecutive better postoperative weight loss and significantly improved long-term weight maintenance. The study will not investigate the GaBP-Ring as medical product but the effect of the GaBP-Ring on weight loss in comparison to gastric bypass alone.

GABY is designed as an international, multi center, open, prospective, randomized study to compare two methods of bariatric surgery: Banded versus conventional laparoscopic Roux-en-Y gastric bypass. At least 16 international high volume centres of excellence in bariatric surgery and at least 384 patients (24 patients at each center) in total will be included into this study. At least 320 patients must have completed the study after 5 years. Surgery will be performed according to standardized operating protocol. The group A (control group) will follow the worldwide golden standard of bariatric surgery (gastric bypass). Patients randomised to group B will receive in addition a restrictive silastic ring. The ring is a launched medical product and is registered in the European Community.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

384

Conditions

Morbid Obesity Requiring Bariatric Surgery

Interventions

Conventional laparoscopic Roux-en-Y gastric bypassPROCEDURE

Conventional laparoscopic Roux-en-Y gastric bypass

conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ringPROCEDURE

conventional laparoscopic Roux-en-Y gastric bypass with additional restrictive silastic ring (GaBP-Ring)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * BMI ≥ 40 kg /m2 to ≤ 50 kg/m2 * Eating habit: sweet eater and volume eater * Signed informed consent * Patients with one or more of the following comorbidities: Hypertension, Diabetes mellitus Type 2, Hyperlipidemia, Hyperuricemia, Sleep apnea, Degenerative diseases of: Spine osteochondrosis, hip, knee, feet Exclusion Criteria: * History of obesity surgery * History of major abdominal surgery with consecutive malabsorption (no resections of the stomach, small and large bowel (exception: appendectomy) * Patients not eligible to implement silastic ring size 6.5 cm * History of drug or alcohol abuse * History of major psychiatric illness conflicting with patient's compliance * History of recent or chronic steroid medication * Autoimmune disease * Inflammatory bowel disease or malabsorptive disease * Liver cirrhosis (CHILD B + C) * Active viral or bacterial disease (e.g. HIV, Hepatitis B or C, Tbc etc.) * Pregnant women or women with childbearing potential without efficient contraception * History of cancer in the last five years * Need of long-term anticoagulant medication for any reason * Any medication with ingredient ASA