Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-02-22 @ 11:00 AM
Study NCT ID:
NCT02290418
Status:
UNKNOWN
Last Update Posted:
2014-11-14
First Post:
2014-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Roux-en-Y Gastric Bypass (RYGB) Versus Omega-Loop Gastric Bypass (OLGB) Safety and Efficacy Short-term Study
Sponsor:
Nemocnice Břeclav, p.o.
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2014-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROSESS
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: