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

NCT02290418 | Unknown

• 1 other identifier: RYGBvsOLGB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Severe; Diabetes Mellitus, Type 2

Keywords

Roux-en-Y Gastric Bypass; Omega-Loop Gastric Bypass; "Mini-Gastric" Bypass

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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

Other Outcomes (5)

• Operative time, measured in minutes

  intraoperative

• Length of inpatient stay due to performance of assigned intervention, measured in days

  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

Study Arms (2)

Roux-en-Y Gastric Bypass

ACTIVE COMPARATOR

Laparoscopic Roux-en-Y Gastric Bypass and routine care.

Procedure: Roux-en-Y Gastric Bypass

Omega-Loop Gastric Bypass

ACTIVE COMPARATOR

Laparoscopic Omega-Loop Gastric Bypass and routine care.

Procedure: Omega-Loop Gastric Bypass

Interventions

Roux-en-Y Gastric Bypass PROCEDURE

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.

Also known as: RYGB

Roux-en-Y Gastric Bypass

Omega-Loop Gastric Bypass PROCEDURE

Laparoscopic Gastric Bypass performed with single anastomosis (gastro-enteral) connecting a long gastric pouch to small bowel with Afferent limb of length 200cm.

Also known as: OLGB, Mini-Gastric Bypass, Single Anastomosis Gastric Bypass

Omega-Loop Gastric Bypass

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nemocnice Břeclav, p.o.: lead

Study Sites (1)

Bariatric Clinic, Breclav Hospital

Břeclav, 690 74, Czechia

Location

Related 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.

MeSH Terms

Conditions

Obesity, Morbid; Diabetes Mellitus, Type 2

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Michal Cierny, Dr.

  Breclav Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: bariatric surgeon

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 14, 2014
• Study Start: January 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2018
• Last Updated: November 14, 2014

Record last verified: 2014-11

Locations

CZ (1)