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Omega Loop Versus Roux-en-Y Gastric Bypass (YOMEGA)

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ClinicalTrials.gov Identifier: NCT02139813
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Several prospective trials and metaanalysis have demonstrated the superiority of bariatric surgery on the medical treatment of obesity. The Roux-en-Y Gastric ByPass (RYGBP) procedure has been practiced for more than 30 years, and is the procedure of choice for morbidly obese with metabolic disorders in most of the reference centers. Nevertheless, the RYGBP is a technically demanding procedure with a learning curve of more than 75 cases. The complication rate is around 10% in expert centers.

More recently another procedure has been described which seems as efficient on weight loss and co-morbidities as the RYGBP, with the advantage of being less technically difficult and less morbid, especially for multi-complicated obese and/or the super obese. It consists of a unique gastro-jejunal anastomosis between a long gastric pouch and a jejunal Omega loop. However, this procedure could be at risk of biliary reflux and anastomotic ulcers with dysplastic changes of the gastric and esophageal mucosa. As a result, the Omega loop bypass (OLB) has only been developed by a few teams and remains a controversial subject, particularly as only one monocentric randomized trial has compared it to the RYGBP, which is remains the gold standard. The first litterature results show similar or even better weight loss efficiency than RYGBP with a better feasibility. The early complication rate seems lower, but there are still insufficient data on long term morbidity and biliary reflux consequences.

By performing a randomized and prospective comparison of OLB to RYGBP, the aim of the investigators study is to analyze the weight loss efficiency, the morbidity and mortality, the feasibility, and the quality of life of both techniques, in order to validate the Omega loop bypass as a procedure of choice in bariatric surgery

Hypothesis :

The OLB, while being as efficient as RYGBP on weight loss and metabolic complications, could be less morbid.


Condition or disease Intervention/treatment Phase
Obesity Procedure: Laparoscopic Mini-gastric bypass Procedure: Procedure of reference in bariatric surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Multicentric Randomized Trial of Efficiency and Safety of Laparoscopic Omega Loop Bypass Versus Roux-en-Y Gastric Bypass
Actual Study Start Date : May 2014
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Laparoscopic Omega Loop Bypass
Laparoscopic Mini-gastric bypass
Procedure: Laparoscopic Mini-gastric bypass

The laparoscopic Omega Loop Bypass will consist of:

  • a long gastric tube, stapled approximately 1.5 cm from the left of the lesser curvature of the antrum to the angle of His
  • a narrow gastric tube will be calibrated to be approximately 1.5 cm wide
  • an Omega loop of 200 cm
  • a unique gastro-jejunal anatomosis of 200cm from the ligament of Treitz, using a linear stapler

Active Comparator: Laparoscopic Roux-en-Y Gastric ByPass
Procedure of reference in bariatric surgery
Procedure: Procedure of reference in bariatric surgery

The laparoscopic Roux-en-Y Gastric Bypass will consist of:

  • a small gastric pouch (about 30cc)
  • an antecolic alimentary limb
  • a gastro-jejunal anastomosis using a linear stapler
  • a 150cm long alimentary limb
  • a 50cm biliary limb
  • a latero-lateral jejuno-jejunal anastomosis
  • closure of the mesenteric defects




Primary Outcome Measures :
  1. Weight loss assessment according to Excess BMI Loss percentage (EBL%) [ Time Frame: 2 years after surgery ]

    Weight loss assessment according to Excess BMI Loss percentage (EBL%), calculated using the following formula:

    ((BMI 2 years after surgery - initial BMI) / (initial BMI - 22.5)) X 100



Secondary Outcome Measures :
  1. Weight loss according to absolute weight loss (aWL in kg), Excess Weight Loss percentage (EWL%), EBL% [ Time Frame: 1, 3, 6, 12, 18 and 24 months after surgery ]
  2. Waist size reduction according to absolute waist size (in cm) [ Time Frame: 1, 3, 6, 12, 18 and 24 months after surgery ]
  3. Medical and surgical complication rates [ Time Frame: 1, 12 and 24 months after surgery ]
    Medical and surgical complication rates (anastomotic leaks, biliary reflux, bowel obstruction, anastomotic ulcers, anastomotic stenosis, internal hernia, chronic gastritis, esophagitis, iron deficiency anemia …)

  4. Type and severity of complications [ Time Frame: During the month following surgery (for early complications) and from one month to 24 months postoperatively (for late complications) ]
    Type and severity of early and late complications for each procedure, according to the Dindo-Clavien classification

  5. Operative time [ Time Frame: Recorded on the day of surgery (Day 0) ]
    Operative time (expressed in minutes)

  6. Mean length of stay [ Time Frame: Average period of 5 days from surgery (Day of surgery = D0) until the end of hospitalization, recorded on Visit 4 (Month1 +/- 10 days) ]
    Mean length of stay based on the number of days of hospitalization from surgery (Day of surgery = D0) until the end of hospitalization

  7. Patient's quality of life [ Time Frame: The day before surgery (D-1) and 6, 12 and 24 months after surgery ]
    Patient's quality of life score according to the IWQOL questionnaire and the BAROS questionnaire adapted to bariatric surgery

  8. Metabolic and lipid profile [ Time Frame: During the period of inclusion (D-60 to D-2) and at 6, 12 and 24 months after surgery ]
    Metabolic profile of glucose homeostasis and the lipid profile according to antidiabetic and anitilipidemic treatments, HbA1c level, fasting glycemia, HDL, LDL and TG.

  9. Dumping syndrome and hypoglycemia symptoms [ Time Frame: At 1, 3,6,12,18 and 24 months after surgery ]
    Dumping syndrome and hypoglycemia symptoms will be assessed using the Sigstad questionnaire

  10. Gastroesophageal reflux [ Time Frame: The day before surgery (Day-1) and 6, 12, and 24 months after surgery ]
    Gastroesophageal reflux assessed by items 5 and 27 of the GIQLI questionnaire

  11. Modifications of the gastric and esophageal mucosa [ Time Frame: 2 years after surgery ]
    Histological modifications of the gastric and esophageal mucosa, based on upper GI endoscopy with biopsies

  12. Frequency of diarrhea [ Time Frame: The day before surgery (day-1) and 6, 12, and 24 months after surgery ]
    Frequency of diarrhea based on items 7, 30, 31 and 36 of the GIQLI questionnaire

  13. Nutritional status [ Time Frame: During the period of inclusion (D-60 to D-2) and 6, 12, and 24 months after surgery (The 24-hour steatorrhea will be quantified at 6 months). ]
    Nutritional status, assessed by PTH, vitamin B1, B9, B12, and D levels before and 12 and 24 months after surgery and assessed by hemoglobin, albumin, prealbumin, ferritin, saturation coefficient, before and 6, 12 and 24 months after surgery .



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged between 18 and 65 years old
  • Morbid obesity with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with one or more co-morbidities (type 2 diabetes, arterial hypertension, sleep apnea, dyslipidemia, arthritis)
  • Patient who has benefited from an upper GI endoscopy with biopsies
  • Patient who has benefited from a pluridisciplinary evaluation, with a favorable opinion for a gastric bypass
  • Patient who understands and accepts the need for a long term follow-up
  • Patient who agrees to be included in the study and who signs the informed consent form
  • Patient affiliated to a healthcare insurance plan

Exclusion Criteria:

  • History of esophagitis on upper GI endoscopy (Los Angeles classification)
  • Severe gastroesophageal reflux disease (GERD), resistant to medical treatment
  • Presence of dysplastic modifications of the gastric mucosa or a history of gastric cancer, on upper gastrointestinal endoscopy.
  • Presence of Helicobacter Pylori resistant to medical treatment
  • Presence of an unhealed gastro-duodenal ulcer or an ulcer diagnosed less than 2 months previously
  • History of previous bariatric surgery (gastric band, sleeve gastrectomy, vertical banded gastroplasty)
  • Presence of a severe and evolutive life threatening pathology, unrelated to obesity
  • Presence of chronic diarrhea (≥ 3 loose or liquid stools per day, over a period of more than 4 weeks)
  • Pregnancy or desire to be pregnant during the study
  • Binge eating disorders or other eating disorders according to DSM V criteria
  • Mentally unbalanced patients, under supervision or guardianship
  • Patient who does not understand French/is unable to give consent
  • Patient not affiliated to a French or European healthcare insurance
  • Patient who has already been included in a trial which has a conflict of interests with the present study

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): NCT02139813


Locations
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France
Clinique Universitaire de Chirurgie Digestive et de l'Urgence - CHU de Grenoble
Grenoble, France, 38043
Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche
Guilherand-Granges, France, 07500
Service de Chirurgie Générale et Endocrinienne - Hôpital Claude Huriez - CHU de Lille
Lille, France, 59037
Service de Chirurgie Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, France, 69437
Service de Chirurgie Digestive et Hépato-Bilio-Pancréatique et Transplantation Hépatique - Hôpital de la Pitié Salpêtrière
Paris, France, 75013
Service de Chirurgie Digestive, Générale et Cancérologique - Hôpital Européen Georges Pompidou - APHP
Paris, France, 75908
Service de Chirurgie Générale - Hôpital Privé de la Loire
Saint Etienne, France, 42100
Service de Chirurgie Digestive et Hépato-Biliaire-Centre Hospitalier Privé Saint Grégoire
Saint Grégoire, France, 35768
Service de Chirurgie Générale, Digestive et Viscérale - Centre Hospitalier Intercommunal de Poissy / Saint Gerrmain en Laye
Saint-germain-en-laye, France, 78100
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Maud ROBERT, MD Service de Chirurgie Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon - France
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02139813    
Other Study ID Numbers: 2014.851
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Keywords provided by Hospices Civils de Lyon:
Obesity -
Bariatric surgery
Gastric bypass
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight