Obesity, SevereROSESSNCT02290418
Roux-en-Y Gastric Bypass (RYGB) Versus Omega-Loop Gastric Bypass (OLGB) Safety and Efficacy Short-term Study
A study testing Roux-en-Y Gastric Bypass and Omega-Loop Gastric Bypass in people with Obesity, Severe and Diabetes Mellitus, Type 2, run by Nemocnice Břeclav, p.o. at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Severe, Diabetes Mellitus, Type 2
- What is being tested?
- Roux-en-Y Gastric Bypass and Omega-Loop Gastric Bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2012to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- active smoker
- chronic renal disease, stage ≥ 3
- patient immobility
- surgery not covered by universal insurance in Czech rep. (i.e. international patients)
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Obesity, Severe, Diabetes Mellitus, Type 2
- Being tested
- Roux-en-Y Gastric Bypass, Omega-Loop Gastric Bypass
- Keywords
- Roux-en-Y Gastric Bypass, Omega-Loop Gastric Bypass, "Mini-Gastric" Bypass
- Medical subject headings
- Obesity, Morbid, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y Gastric BypassProcedure or surgery
Also called RYGB
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.
Omega-Loop Gastric BypassProcedure or surgery
Also called OLGB, Mini-Gastric Bypass, Single Anastomosis 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.
| Study group | Role | What they receive |
|---|---|---|
| Roux-en-Y Gastric Bypass | Active comparator | Laparoscopic Roux-en-Y Gastric Bypass and routine care. Receives: Procedure: Roux-en-Y Gastric Bypass |
| Omega-Loop Gastric Bypass | Active comparator | Laparoscopic Omega-Loop Gastric Bypass and routine care. Receives: Procedure: Omega-Loop Gastric Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 1 and 2 years
Secondary outcomes (15)
Change in weight, measured as Percent of Excess Weight Loss (%EWL)
Measured: baseline, 1 and 2 years
Change in weight, measured as Percent of Excess Body Mass Index Loss (%EBMIL)
Measured: baseline, 1 and 2 years
Change in Type 2 Diabetes Mellitus, measured as intensity of medical treatment: increased, same, decreased, or discontinued
Measured: 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)
Measured: 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"
Measured: 2 years
Change in Hypertension, measured as intensity of medical treatment: increased, same, decreased, or discontinued
Measured: baseline, 1 and 2 years
Change in Dyslipidemia, measured as intensity of medical treatment: increased, same, decreased, or discontinued
Measured: baseline, 1 and 2 years
Change in Obstructive Sleep Apnea (OSA), measured as the need of use of mouth device
Measured: baseline, 1 and 2 years
Change in Obstructive Sleep Apnea, measured as score on Epworth questionnaire scale
Measured: 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
Measured: 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
Measured: up to 5 years
Incidence of early postoperative (<=30 days) Reoperations and Complications of grade >= 2 according to Clavien-Dindo classification
Measured: 30 days
Incidence of late (>30 days) Reoperations, Complications, and detected adverse outcomes
Measured: 1 and 2 years
Incidence of Reoperations, Complications, and detected adverse outcomes, measured as Rate of Event per 100 patient-years of follow up
Measured: up to 5 years
Change in Quality of Life, as measured by Moorehead-Ardelt Questionnaire II
Measured: baseline, 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startJan 2012
- Primary completionJun 2016 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, SevereStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemocnice Břeclav, p.o.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Michal Cierny, PhD, Nemocnice Břeclav, p.o.
- Investigators
- Michal Cierny, Dr., Study director, Breclav Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290418
- Sponsor's protocol ID
- RYGBvsOLGB
- Acronym
- ROSESS
- Status last verified
- Nov 2014
- First submitted
- 31 Oct 2014
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02290418
- Acronym / sponsor ID
- ROSESS / RYGBvsOLGB
- Conditions
- Obesity, Severe, Diabetes Mellitus, Type 2
- Keywords
- Roux-en-Y Gastric Bypass, Omega-Loop Gastric Bypass, "Mini-Gastric" Bypass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nemocnice Břeclav, p.o.University, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roux-en-Y Gastric Bypass | Active comparator | Procedure: Roux-en-Y Gastric BypassLaparoscopic Roux-en-Y Gastric Bypass and routine care. |
| Omega-Loop Gastric Bypass | Active comparator | Procedure: Omega-Loop Gastric BypassLaparoscopic Omega-Loop Gastric Bypass and routine care. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-Y Gastric BypassAlso: RYGBLaparoscopic 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. | Procedure or surgery | Roux-en-Y Gastric Bypass |
| Omega-Loop Gastric BypassAlso: OLGB, Mini-Gastric Bypass, Single Anastomosis Gastric BypassLaparoscopic Gastric Bypass performed with single anastomosis (gastro-enteral) connecting a long gastric pouch to small bowel with Afferent limb of length 200cm. | Procedure or surgery | Omega-Loop Gastric Bypass |
Primary outcome
Composite measure of success of bariatric surgery as measured by Bariatric Analysis and Reporting Outcome System (BAROS)
Time frame: baseline, 1 and 2 years
BAROS composite score rates weight loss, change in comorbidities, and quality of life.
15 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
- Laparoscopic Roux-en-Y versus mini-gastric bypass for the treatment of morbid obesity: a prospective randomized controlled clinical trial.Link provided by the sponsor.
- Laparoscopic Roux-en-Y Vs. Mini-gastric Bypass for the Treatment of Morbid Obesity: a 10-Year ExperienceLink provided by the sponsor.
- Greater Weight Loss with the Omega Loop Bypass Compared to the Roux-en-Y Gastric Bypass: a Comparative StudyLink provided by the sponsor.
- "Mini" Gastric Bypass: Systematic Review of a Controversial ProcedureLink provided by the sponsor.
- Weight Loss Surgery ResultsLink provided by the sponsor.
- Interdisciplinary European guidelines on metabolic and bariatric surgery.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michal Cierny, Dr. study director
Breclav Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-Y Gastric Bypass and Omega-Loop Gastric Bypass in people with Obesity, Severe and Diabetes Mellitus, Type 2, run by Nemocnice Břeclav, p.o. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite measure of success of bariatric surgery as measured by Bariatric Analysis and Reporting Outcome System (BAROS) (time frame: baseline, 1 and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2014.