Roux-en-Y Gastric Bypass (RYGB) Versus Omega-Loop Gastric Bypass (OLGB) Safety and Efficacy Short-term Study (ROSESS)

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2; Obesity, Severe
• Intervention / Treatment: Procedure: Roux-en-Y Gastric Bypass; Procedure: Omega-Loop Gastric Bypass

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czech Republic
  • Breclav, Czech Republic, 690 74
    • Bariatric Clinic, Breclav Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Roux-en-Y Gastric Bypass; Laparoscopic Roux-en-Y Gastric Bypass and routine care.	Procedure: Roux-en-Y 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.; Other Names: RYGB
Active Comparator: Omega-Loop Gastric Bypass; Laparoscopic Omega-Loop Gastric Bypass and routine care.	Procedure: Omega-Loop Gastric Bypass; Laparoscopic Gastric Bypass performed with single anastomosis (gastro-enteral) connecting a long gastric pouch to small bowel with Afferent limb of length 200cm.; Other Names: Mini-Gastric Bypass; Single Anastomosis Gastric Bypass; OLGB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, 1 and 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in weight, measured as Percent of Excess Weight Loss (%EWL)	baseline, 1 and 2 years
Change in weight, measured as Percent of Excess Body Mass Index Loss (%EBMIL)	baseline, 1 and 2 years
Change in Type 2 Diabetes Mellitus, measured as intensity of medical treatment: increased, same, decreased, or discontinued	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)	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"	2 years
Change in Hypertension, measured as intensity of medical treatment: increased, same, decreased, or discontinued	baseline, 1 and 2 years
Change in Dyslipidemia, measured as intensity of medical treatment: increased, same, decreased, or discontinued	baseline, 1 and 2 years
Change in Obstructive Sleep Apnea (OSA), measured as the need of use of mouth device	baseline, 1 and 2 years
Change in Obstructive Sleep Apnea, measured as score on Epworth questionnaire scale	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	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	up to 5 years
Incidence of early postoperative (<=30 days) Reoperations and Complications of grade >= 2 according to Clavien-Dindo classification	30 days
Incidence of late (>30 days) Reoperations, Complications, and detected adverse outcomes	1 and 2 years
Incidence of Reoperations, Complications, and detected adverse outcomes, measured as Rate of Event per 100 patient-years of follow up	up to 5 years
Change in Quality of Life, as measured by Moorehead-Ardelt Questionnaire II	baseline, 1 and 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time, measured in minutes		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	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%		baseline, 1 and 2 years
Change in body weight, measured in kilograms (kg)		baseline, 1 and 2 years
Change in Body Mass Index (BMI), measured in kg/m2		baseline, 1 and 2 years

Collaborators and Investigators

• Sponsor: Nemocnice Břeclav, p.o.
• Investigators: Study Director: Michal Cierny, Dr., Breclav Hospital

Publications and helpful links

Helpful Links

• Laparoscopic Roux-en-Y versus mini-gastric bypass for the treatment of morbid obesity: a prospective randomized controlled clinical trial.
• Laparoscopic Roux-en-Y Vs. Mini-gastric Bypass for the Treatment of Morbid Obesity: a 10-Year Experience
• Greater Weight Loss with the Omega Loop Bypass Compared to the Roux-en-Y Gastric Bypass: a Comparative Study
• "Mini" Gastric Bypass: Systematic Review of a Controversial Procedure
• Weight Loss Surgery Results
• Interdisciplinary European guidelines on metabolic and bariatric surgery.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: October 31, 2014
• First Submitted That Met QC Criteria: November 10, 2014
• First Posted (Estimate): November 14, 2014

Study Record Updates

• Last Update Posted (Estimate): November 14, 2014
• Last Update Submitted That Met QC Criteria: November 10, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Roux-en-Y Gastric Bypass; Omega-Loop Gastric Bypass; "Mini-Gastric" Bypass
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Diabetes Mellitus, Type 2; Obesity; Obesity, Morbid
• Other Study ID Numbers: RYGBvsOLGB