Clinical trial NCT02290418: Roux-en-Y Gastric Bypass (RYGB) Versus Omega-Loop Gastric Bypass (OLGB) Safety and Efficacy Short-term Study
Official title: Prospective Randomized Controlled Clinical Study Comparing Two Bariatric Bypass Procedures, Roux-en-Y Gastric Bypass (RYGB) and Omega-Loop Gastric Bypass (OLGB), in Patients With Severe Obesity and Metabolic Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity, Severe
Diabetes Mellitus, Type 2
Keywords: Roux-en-Y Gastric Bypass
Omega-Loop Gastric Bypass
"Mini-Gastric" Bypass
Lead sponsor: Nemocnice Břeclav, p.o.
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Severe Obesity: BMI ≥ 40 and ≤ 50 or (BMI ≥ 35 and \< 40 and type 2 diabetes or metabolic syndrome)
* Inadequate results of Attempts to loose weight by Conservative means
* Ability to understand the nature of the procedure and willing to follow postoperative routine lifestyle and checkups
* no contraindication for bariatric surgery on psychological assessment
* no contraindication for general anesthesia
* consent for both variants of gastric bypass surgery
* consent to participate in a study with randomized design

Exclusion Criteria:

* prior bariatric surgery of any kind
* gravidity or recent (\<1 year) labour
* drug or alcohol abuse
* symptomatic Gastro Esophageal Reflux Disease (GERD)
* hiatal hernia, \> 3cm
* esophagitis, ≥ 2. grade
* active smoker
* chronic renal disease, stage ≥ 3
* patient immobility
* surgery not covered by universal insurance in Czech rep. (i.e. international patients)

Primary outcomes:
measure: Composite measure of success of bariatric surgery as measured by Bariatric Analysis and Reporting Outcome System (BAROS)
timeFrame: baseline, 1 and 2 years
Secondary outcomes:
measure: Change in weight, measured as Percent of Excess Weight Loss (%EWL)
timeFrame: baseline, 1 and 2 years
measure: Change in weight, measured as Percent of Excess Body Mass Index Loss (%EBMIL)
timeFrame: baseline, 1 and 2 years
measure: Change in Type 2 Diabetes Mellitus, measured as intensity of medical treatment: increased, same, decreased, or discontinued
timeFrame: baseline, 1 and 2 years
measure: Change in Type 2 Diabetes Mellitus, measured as intensity of treatment: diet alone, oral antidiabetic agent(s), insulin (IU/day)
timeFrame: baseline, 1 and 2 years
measure: Durability of change in Type 2 Diabetes Mellitus, measured as proportion of patients with T2DM partial remission who experience T2DM "relapse"
timeFrame: 2 years
measure: Change in Hypertension, measured as intensity of medical treatment: increased, same, decreased, or discontinued
timeFrame: baseline, 1 and 2 years
measure: Change in Dyslipidemia, measured as intensity of medical treatment: increased, same, decreased, or discontinued
timeFrame: baseline, 1 and 2 years
measure: Change in Obstructive Sleep Apnea (OSA), measured as the need of use of mouth device
timeFrame: baseline, 1 and 2 years
measure: Change in Obstructive Sleep Apnea, measured as score on Epworth questionnaire scale
timeFrame: baseline, 1 and 2 years
measure: Incidence of Ulcer or other Abnormal Finding on Endoscopic Gastroscopy, measured as proportion of patients with abnormal finding in each arm
timeFrame: 1 and 2 years
measure: Incidence of Ulcer or other Abnormal Finding on Endoscopic Gastroscopy, measured as Rate of unique Event per 100 patient-years of follow up
timeFrame: up to 5 years
measure: Incidence of early postoperative (<=30 days) Reoperations and Complications of grade >= 2 according to Clavien-Dindo classification
timeFrame: 30 days
measure: Incidence of late (>30 days) Reoperations, Complications, and detected adverse outcomes
timeFrame: 1 and 2 years
measure: Incidence of Reoperations, Complications, and detected adverse outcomes, measured as Rate of Event per 100 patient-years of follow up
timeFrame: up to 5 years
measure: Change in Quality of Life, as measured by Moorehead-Ardelt Questionnaire II
timeFrame: baseline, 1 and 2 years
Other outcomes:
measure: Operative time, measured in minutes
timeFrame: intraoperative
measure: Length of inpatient stay due to performance of assigned intervention, measured in days
timeFrame: recorded at time of discharge, estimated average 4 days from the surgery
measure: Change in body weight, measured as proportion of patients with EWL > 50%, and proportion of patients with EWL < 25%
timeFrame: baseline, 1 and 2 years
measure: Change in body weight, measured in kilograms (kg)
timeFrame: baseline, 1 and 2 years
measure: Change in Body Mass Index (BMI), measured in kg/m2
timeFrame: baseline, 1 and 2 years
Locations:
city: Breclav
country: Czech Republic
facility: Bariatric Clinic, Breclav Hospital
Study officials:
affiliation: Breclav Hospital
name: Michal Cierny, Dr.
role: STUDY_DIRECTOR
References: