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

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ClinicalTrials.gov Identifier: NCT02290418
Recruitment Status : Unknown
Verified November 2014 by Dr. Michal Cierny, PhD, Nemocnice Břeclav, p.o..
Recruitment status was:  Active, not recruiting
First Posted : November 14, 2014
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Michal Cierny, PhD, Nemocnice Břeclav, p.o.

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.

Condition or disease Intervention/treatment Phase
Obesity, Severe Diabetes Mellitus, Type 2 Procedure: Roux-en-Y Gastric Bypass Procedure: Omega-Loop Gastric Bypass Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2012
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2018

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 Name: 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:
  • OLGB
  • Mini-Gastric Bypass
  • Single Anastomosis Gastric Bypass




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in weight, measured as Percent of Excess Weight Loss (%EWL) [ Time Frame: baseline, 1 and 2 years ]
  2. Change in weight, measured as Percent of Excess Body Mass Index Loss (%EBMIL) [ Time Frame: baseline, 1 and 2 years ]
  3. Change in Type 2 Diabetes Mellitus, measured as intensity of medical treatment: increased, same, decreased, or discontinued [ Time Frame: baseline, 1 and 2 years ]
  4. 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 ]
  5. 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 ]
  6. Change in Hypertension, measured as intensity of medical treatment: increased, same, decreased, or discontinued [ Time Frame: baseline, 1 and 2 years ]
  7. Change in Dyslipidemia, measured as intensity of medical treatment: increased, same, decreased, or discontinued [ Time Frame: baseline, 1 and 2 years ]
  8. Change in Obstructive Sleep Apnea (OSA), measured as the need of use of mouth device [ Time Frame: baseline, 1 and 2 years ]
  9. Change in Obstructive Sleep Apnea, measured as score on Epworth questionnaire scale [ Time Frame: baseline, 1 and 2 years ]
  10. 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 ]
  11. 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 ]
  12. Incidence of early postoperative (<=30 days) Reoperations and Complications of grade >= 2 according to Clavien-Dindo classification [ Time Frame: 30 days ]
  13. Incidence of late (>30 days) Reoperations, Complications, and detected adverse outcomes [ Time Frame: 1 and 2 years ]
  14. 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 ]
  15. Change in Quality of Life, as measured by Moorehead-Ardelt Questionnaire II [ Time Frame: baseline, 1 and 2 years ]

Other Outcome Measures:
  1. Operative time, measured in minutes [ Time Frame: intraoperative ]
  2. Length of inpatient stay due to performance of assigned intervention, measured in days [ Time Frame: recorded at time of discharge, estimated average 4 days from the surgery ]
    number of days from the day of surgery (Post Operative Day 0) until the end of hospitalization

  3. 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 ]
  4. Change in body weight, measured in kilograms (kg) [ Time Frame: baseline, 1 and 2 years ]
  5. Change in Body Mass Index (BMI), measured in kg/m2 [ Time Frame: baseline, 1 and 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290418


Locations
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Czech Republic
Bariatric Clinic, Breclav Hospital
Breclav, Czech Republic, 690 74
Sponsors and Collaborators
Nemocnice Břeclav, p.o.
Investigators
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Study Director: Michal Cierny, Dr. Breclav Hospital
Additional Information:
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Responsible Party: Dr. Michal Cierny, PhD, bariatric surgeon, Nemocnice Břeclav, p.o.
ClinicalTrials.gov Identifier: NCT02290418    
Other Study ID Numbers: RYGBvsOLGB
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014
Keywords provided by Dr. Michal Cierny, PhD, Nemocnice Břeclav, p.o.:
Roux-en-Y Gastric Bypass
Omega-Loop Gastric Bypass
"Mini-Gastric" Bypass
Additional relevant MeSH terms:
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Obesity
Diabetes Mellitus, Type 2
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases