An interventional study of Roux-en-Y Gastric Bypass and Omega-Loop Gastric Bypass in Obesity, Severe and Diabetes Mellitus, Type 2, sponsored by Nemocnice Břeclav, p.o.. Status unknown at 1 site in Czech Republic. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-11-14.
Sponsored by Nemocnice Břeclav, p.o. · Not applicable, Interventional, and Treatment
The aim of this study is to compare the relative clinical outcomes between two variants of gastric bypass [Roux-en-Y Gastric Bypass (RYGB) or Omega-Loop Gastric Bypass (OLGB)] in metabolic surgery candidates with Body Mass Index (BMI) between 35 and 50. The study will examine the short and medium term effects of each intervention on weight, obesity comorbidities, quality of life and gastroscopy findings.
Introduction:
Obesity is a risk factor for Diabetes, Ischemic heart disease, Stroke, and Hypertensive heart disease, which are the 6th, 1st, 2nd, and 10th leading causes of death according to the WHO. Bariatric or Metabolic Surgery is an Efficient and reasonably Safe method for the Treatment of Severe Obesity, Type 2 Diabetes (T2DM) and Metabolic Syndrome (MS).
Existing knowledge:
Metabolic procedures, e.g. Gastric bypass, are more effective in the treatment of T2DM than predominantly "restrictive" procedures, e.g. Gastric Banding. RYGB is one of the most prevalent procedures in the world and Europe. In the USA, RYGB is considered a "golden standard" in bariatric surgery. In the recent decade, a simpler variant of Gastric bypass, i.e. OLGB, has been proposed. Proponents of OLGB argue it has less complications and seems to have higher and more durable effect on weight reduction and T2DM improvement. Opponents of OLGB are concerned that chronic exposure of gastric or esophageal mucosa to bile, as seen in animal experiments and in patients operated for gastric cancer or peptic ulcer disease, pose a severe health risk. So far, this concerns has not been confirmed in OLGB patients. Only one Randomized Controlled Trial (RCT) of these two interventions was performed, concluding OLGB to be simpler and safer with a similar Efficacy 2 years after the surgery.
Need for a trial:
A growing evidence supports the efficacy and safety of bariatric and metabolic surgery for the treatment of severe obesity and T2DM. Therefore, bariatric surgery is being more frequently performed. However, there is little evidence from randomized trials comparing different bariatric procedures - most comes from retrospective cohorts, which might suffer from bias. As a result, the choice of a bariatric procedure for a particular patient is based largely on the preference and experience of the particular surgeon, rather than evidence of best benefit for a particular patient. Although the efficacy and safety of RYGB is well established, newer variants or other less frequently employed bariatric procedures might offer more preferable Efficacy or Safety profile for some patients. Some evidence suggests OLGB might a promising procedure, which is "simpler and safer with similar efficacy" in comparison to RYGB, a technically more demanding procedure. This study contributes with rigorous evidence to further define the relative strengths and weaknesses of OLGB as compared to the "gold standard" RYGB.
Objectives:
The purpose of this study is to objectively compare the efficacy of RYGB and OLGB on weight, T2DM and other obesity-related comorbidities. Furthermore, this study aims to provide more insight into the safety of OLGB and RYGB by measuring the incidence of complications and abnormal findings on Gastroscopy.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 50 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →This is the only study on the registry with Nemocnice Břeclav, p.o. as lead sponsor.
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Exclusion Criteria:
Laparoscopic Roux-en-Y Gastric Bypass and routine care.
Procedure: Roux-en-Y Gastric Bypass
Laparoscopic Omega-Loop Gastric Bypass and routine care.
Procedure: Omega-Loop Gastric Bypass
Laparoscopic Gastric Bypass performed with two anastomoses (gastro-enteral and entero- enteral), two limbs (Alimentary limb of length 150cm and Biliary limb of length 75-100cm) and sewing of mesenteric defect.
Also known as: RYGB
Laparoscopic Gastric Bypass performed with single anastomosis (gastro-enteral) connecting a long gastric pouch to small bowel with Afferent limb of length 200cm.
Also known as: OLGB, Mini-Gastric Bypass, Single Anastomosis Gastric Bypass
Composite measure of success of bariatric surgery as measured by Bariatric Analysis and Reporting Outcome System (BAROS)
BAROS composite score rates weight loss, change in comorbidities, and quality of life.
Time frame: baseline, 1 and 2 years
Change in weight, measured as Percent of Excess Weight Loss (%EWL)
Time frame: baseline, 1 and 2 years
Change in weight, measured as Percent of Excess Body Mass Index Loss (%EBMIL)
Time frame: baseline, 1 and 2 years
Change in Type 2 Diabetes Mellitus, measured as intensity of medical treatment: increased, same, decreased, or discontinued
Time frame: baseline, 1 and 2 years
Change in Type 2 Diabetes Mellitus, measured as intensity of treatment: diet alone, oral antidiabetic agent(s), insulin (IU/day)
Time frame: baseline, 1 and 2 years
Durability of change in Type 2 Diabetes Mellitus, measured as proportion of patients with T2DM partial remission who experience T2DM "relapse"
Time frame: 2 years
Change in Hypertension, measured as intensity of medical treatment: increased, same, decreased, or discontinued
Time frame: baseline, 1 and 2 years
Change in Dyslipidemia, measured as intensity of medical treatment: increased, same, decreased, or discontinued
Time frame: baseline, 1 and 2 years
Change in Obstructive Sleep Apnea (OSA), measured as the need of use of mouth device
Time frame: baseline, 1 and 2 years
Change in Obstructive Sleep Apnea, measured as score on Epworth questionnaire scale
Time frame: baseline, 1 and 2 years
Incidence of Ulcer or other Abnormal Finding on Endoscopic Gastroscopy, measured as proportion of patients with abnormal finding in each arm
Time frame: 1 and 2 years
Incidence of Ulcer or other Abnormal Finding on Endoscopic Gastroscopy, measured as Rate of unique Event per 100 patient-years of follow up
Time frame: up to 5 years
Incidence of early postoperative (<=30 days) Reoperations and Complications of grade >= 2 according to Clavien-Dindo classification
Time frame: 30 days
Incidence of late (>30 days) Reoperations, Complications, and detected adverse outcomes
Time frame: 1 and 2 years
Incidence of Reoperations, Complications, and detected adverse outcomes, measured as Rate of Event per 100 patient-years of follow up
Time frame: up to 5 years
Change in Quality of Life, as measured by Moorehead-Ardelt Questionnaire II
Time frame: baseline, 1 and 2 years
Operative time, measured in minutes
Time frame: intraoperative
Length of inpatient stay due to performance of assigned intervention, measured in days
number of days from the day of surgery (Post Operative Day 0) until the end of hospitalization
Time frame: recorded at time of discharge, estimated average 4 days from the surgery
Change in body weight, measured as proportion of patients with EWL > 50%, and proportion of patients with EWL < 25%
Time frame: baseline, 1 and 2 years
Change in body weight, measured in kilograms (kg)
Time frame: baseline, 1 and 2 years
Change in Body Mass Index (BMI), measured in kg/m2
Time frame: baseline, 1 and 2 years
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