Omega Loop Versus Roux-en-Y Gastric Bypass

Hospices Civils de Lyon256 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Interventions

Laparoscopic Mini-gastric bypassPROCEDURE

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

Procedure of reference in bariatric surgeryPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (9)

Clinique Universitaire de Chirurgie Digestive et de l'Urgence - CHU de Grenoble

Grenoble, France

Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche

Guilherand-Granges, France

Service de Chirurgie Générale et Endocrinienne - Hôpital Claude Huriez - CHU de Lille

Lille, France

Service de Chirurgie Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon

Lyon, France

Service de Chirurgie Digestive et Hépato-Bilio-Pancréatique et Transplantation Hépatique - Hôpital de la Pitié Salpêtrière

Paris, France

Service de Chirurgie Digestive, Générale et Cancérologique - Hôpital Européen Georges Pompidou - APHP

Paris, France

Service de Chirurgie Générale - Hôpital Privé de la Loire

Saint-Etienne, France

Service de Chirurgie Générale, Digestive et Viscérale - Centre Hospitalier Intercommunal de Poissy / Saint Gerrmain en Laye

Saint-Germain-en-Laye, France

Service de Chirurgie Digestive et Hépato-Biliaire-Centre Hospitalier Privé Saint Grégoire

Saint-Grégoire, France

Outcomes

Primary Outcomes

Weight loss assessment according to Excess BMI Loss percentage (EBL%)

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

Time frame: 2 years after surgery

Secondary Outcomes

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

Waist size reduction according to absolute waist size (in cm)

Time frame: 1, 3, 6, 12, 18 and 24 months after surgery

Medical and surgical complication rates

Medical and surgical complication rates (anastomotic leaks, biliary reflux, bowel obstruction, anastomotic ulcers, anastomotic stenosis, internal hernia, chronic gastritis, esophagitis, iron deficiency anemia …)

Time frame: 1, 12 and 24 months after surgery

Type and severity of complications

Type and severity of early and late complications for each procedure, according to the Dindo-Clavien classification

Time frame: During the month following surgery (for early complications) and from one month to 24 months postoperatively (for late complications)

Operative time

Operative time (expressed in minutes)

Time frame: Recorded on the day of surgery (Day 0)

Mean length of stay

Mean length of stay based on the number of days of hospitalization from surgery (Day of surgery = D0) until the end of hospitalization

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)

Patient's quality of life

Patient's quality of life score according to the IWQOL questionnaire and the BAROS questionnaire adapted to bariatric surgery

Time frame: The day before surgery (D-1) and 6, 12 and 24 months after surgery

Metabolic and lipid profile

Metabolic profile of glucose homeostasis and the lipid profile according to antidiabetic and anitilipidemic treatments, HbA1c level, fasting glycemia, HDL, LDL and TG.

Time frame: During the period of inclusion (D-60 to D-2) and at 6, 12 and 24 months after surgery

Dumping syndrome and hypoglycemia symptoms

Dumping syndrome and hypoglycemia symptoms will be assessed using the Sigstad questionnaire

Time frame: At 1, 3,6,12,18 and 24 months after surgery

Gastroesophageal reflux

Gastroesophageal reflux assessed by items 5 and 27 of the GIQLI questionnaire

Time frame: The day before surgery (Day-1) and 6, 12, and 24 months after surgery

Modifications of the gastric and esophageal mucosa

Histological modifications of the gastric and esophageal mucosa, based on upper GI endoscopy with biopsies

Time frame: 2 years after surgery

Frequency of diarrhea

Frequency of diarrhea based on items 7, 30, 31 and 36 of the GIQLI questionnaire

Time frame: The day before surgery (day-1) and 6, 12, and 24 months after surgery

Nutritional status

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 .

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).