Clinical trial NCT02139813: Omega Loop Versus Roux-en-Y Gastric Bypass
Official title: Prospective Multicentric Randomized Trial of Efficiency and Safety of Laparoscopic Omega Loop Bypass Versus Roux-en-Y Gastric Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity -
Bariatric surgery
Gastric bypass
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Weight loss assessment according to Excess BMI Loss percentage (EBL%)
timeFrame: 2 years after surgery
Secondary outcomes:
measure: Weight loss according to absolute weight loss (aWL in kg), Excess Weight Loss percentage (EWL%), EBL%
timeFrame: 1, 3, 6, 12, 18 and 24 months after surgery
measure: Waist size reduction according to absolute waist size (in cm)
timeFrame: 1, 3, 6, 12, 18 and 24 months after surgery
measure: Medical and surgical complication rates
timeFrame: 1, 12 and 24 months after surgery
measure: Type and severity of complications
timeFrame: During the month following surgery (for early complications) and from one month to 24 months postoperatively (for late complications)
measure: Operative time
timeFrame: Recorded on the day of surgery (Day 0)
measure: Mean length of stay
timeFrame: Average period of 5 days from surgery (Day of surgery = D0) until the end of hospitalization, recorded on Visit 4 (Month1 +/- 10 days)
measure: Patient's quality of life
timeFrame: The day before surgery (D-1) and 6, 12 and 24 months after surgery
measure: Metabolic and lipid profile
timeFrame: During the period of inclusion (D-60 to D-2) and at 6, 12 and 24 months after surgery
measure: Dumping syndrome and hypoglycemia symptoms
timeFrame: At 1, 3,6,12,18 and 24 months after surgery
measure: Gastroesophageal reflux
timeFrame: The day before surgery (Day-1) and 6, 12, and 24 months after surgery
measure: Modifications of the gastric and esophageal mucosa
timeFrame: 2 years after surgery
measure: Frequency of diarrhea
timeFrame: The day before surgery (day-1) and 6, 12, and 24 months after surgery
measure: Nutritional status
timeFrame: 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).
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Clinique Universitaire de Chirurgie Digestive et de l'Urgence - CHU de Grenoble
city: Guilherand-Granges
country: France
facility: Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche
city: Lille
country: France
facility: Service de Chirurgie Générale et Endocrinienne - Hôpital Claude Huriez - CHU de Lille
city: Lyon
country: France
facility: Service de Chirurgie Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon
city: Paris
country: France
facility: Service de Chirurgie Digestive et Hépato-Bilio-Pancréatique et Transplantation Hépatique - Hôpital de la Pitié Salpêtrière
city: Paris
country: France
facility: Service de Chirurgie Digestive, Générale et Cancérologique - Hôpital Européen Georges Pompidou - APHP
city: Saint Etienne
country: France
facility: Service de Chirurgie Générale - Hôpital Privé de la Loire
city: Saint Grégoire
country: France
facility: Service de Chirurgie Digestive et Hépato-Biliaire-Centre Hospitalier Privé Saint Grégoire
city: Saint-germain-en-laye
country: France
facility: Service de Chirurgie Générale, Digestive et Viscérale - Centre Hospitalier Intercommunal de Poissy / Saint Gerrmain en Laye
Study officials:
affiliation: Service de Chirurgie Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon - France
name: Maud ROBERT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robert M, Espalieu P, Pelascini E, Caiazzo R, Sterkers A, Khamphommala L, Poghosyan T, Chevallier JM, Malherbe V, Chouillard E, Reche F, Torcivia A, Maucort-Boulch D, Bin-Dorel S, Langlois-Jacques C, Delaunay D, Pattou F, Disse E. Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for obesity (YOMEGA): a multicentre, randomised, open-label, non-inferiority trial. Lancet. 2019 Mar 30;393(10178):1299-1309. doi: 10.1016/S0140-6736(19)30475-1. Epub 2019 Mar 6.