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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Omega Loop Bypass | Experimental | Laparoscopic Mini-gastric bypass |
|
| Laparoscopic Roux-en-Y Gastric ByPass | Active Comparator | Procedure of reference in bariatric surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Mini-gastric bypass | Procedure | The laparoscopic Omega Loop Bypass will consist of:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss according to absolute weight loss (aWL in kg), Excess Weight Loss percentage (EWL%), EBL% | 1, 3, 6, 12, 18 and 24 months after surgery | |
| Waist size reduction according to absolute waist size (in cm) | 1, 3, 6, 12, 18 and 24 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maud ROBERT, MD | Service de Chirurgie Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon - France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Universitaire de Chirurgie Digestive et de l'Urgence - CHU de Grenoble | Grenoble | 38043 | France | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30851879 | Result | 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. | |
| 38452784 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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|
| Procedure of reference in bariatric surgery | Procedure | The laparoscopic Roux-en-Y Gastric Bypass will consist of:
|
|
| 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 …) | 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 | 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) | 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 | 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 | 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. | 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 | 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 | 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 | 2 years after surgery |
| Frequency of diarrhea | Frequency of diarrhea based on items 7, 30, 31 and 36 of the GIQLI questionnaire | 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 . | 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). |
| Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche |
| Guilherand-Granges |
| 07500 |
| France |
| Service de Chirurgie Générale et Endocrinienne - Hôpital Claude Huriez - CHU de Lille | Lille | 59037 | France |
| Service de Chirurgie Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon | Lyon | 69437 | France |
| Service de Chirurgie Digestive et Hépato-Bilio-Pancréatique et Transplantation Hépatique - Hôpital de la Pitié Salpêtrière | Paris | 75013 | France |
| Service de Chirurgie Digestive, Générale et Cancérologique - Hôpital Européen Georges Pompidou - APHP | Paris | 75908 | France |
| Service de Chirurgie Générale - Hôpital Privé de la Loire | Saint-Etienne | 42100 | France |
| Service de Chirurgie Générale, Digestive et Viscérale - Centre Hospitalier Intercommunal de Poissy / Saint Gerrmain en Laye | Saint-Germain-en-Laye | 78100 | France |
| Service de Chirurgie Digestive et Hépato-Biliaire-Centre Hospitalier Privé Saint Grégoire | Saint-Grégoire | 35768 | France |
| Derived |
| Robert M, Poghosyan T, Maucort-Boulch D, Filippello A, Caiazzo R, Sterkers A, Khamphommala L, Reche F, Malherbe V, Torcivia A, Saber T, Delaunay D, Langlois-Jacques C, Suffisseau A, Bin S, Disse E, Pattou F. Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass at 5 years (YOMEGA): a prospective, open-label, non-inferiority, randomised extension study. Lancet Diabetes Endocrinol. 2024 Apr;12(4):267-276. doi: 10.1016/S2213-8587(24)00035-4. Epub 2024 Mar 4. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |