Three M Study (Malabsorption, Microbiota, Mini-Gastric Bypass)

Study Overview
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Brief Summary
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Bariatric surgery represents the best therapeutic option to induce sustainable weight loss and to solve serious comorbidities improving the life-expectancy and the quality of life. Actually the choice of the procedure is based on the surgeon's and patients preference . Mini gastric bypass(MGB) is an emerging procedure offering excellent results in terms of weight loss and comorbidities (mainly metabolic) control. On the other hand, recent data indicated that the gut microbiota may mediate some of the beneficial effects of bariatric surgery and changes in the composition and diversity of the gut microbiota have been observed after RY Gastric Bypass (RYGB) in humans as well as in mice. However, there are no prospective investigations on Gut Microbiota changes after MGB, despite the procedure is described as malabsorptive and there are no studies comparing gut microbiota shift and malabsorption entity in humans after RYGB vs MGB. Thereafter prospective data on the incidence of bile reflux esophageal lesions after MGB are lacking. The aim of the present multicentric prospective comparative study is to evaluate malabsorption and gut microbiota shift after laparoscopic RYGB vs MGB at 1 year.

Official Title
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Malabsorption and Gut Microbiota Profile Changes After Laparoscopic Mini-Gastric Bypass (MGB) vs Roux-en-Y Gastric Bypass (RYGB): a Prospective Multicenter Comparative Study

Conditions
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Obesity (Disorder)

Intervention / Treatment
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* Procedure: Mini Gastric Bypass
* Procedure: Roux en Y Gastric Bypass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 40-55 kg/m2 Non smokers Primary Mini Gastric Bypass or Roux en Y Gastric Bypass without any concomitant surgeries except hiatal hernia repair Enrollment in the two study groups will be on the basis of patient choice. Exclusion Criteria: Smokers Different bowel measurement (plus or minus 10%). Conversion to open surgery, reoperation Helicobacter Pylori positive previous or current Free PPI 4 weeks before 6th month (after surgery) Corticosteroids, vitamine E, fish oil treatment 2 months before surgery Anti or pre- biotics treatment 2 months before surgery Chronic gastrointestinal diseases or syndromes Previous bariatric surgery (intragastric balloon excluded) Previous resective bowel surgery Previous pancreatic surgery Previous Hepato BilioPancreatic surgery Gallbladder gallstones

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mini Gastric Bypass<br>Mini Gastric Bypass: The gastric pouch will be performed starting below the incisura angularis (transverse resection 4 cm) on the lesser curvature (18).Then the stomach will be transected against a 36 Fr bougie up to the gastro-esophageal junction Then 1/3 of the small bowel will be excluded (approximately 200cms) and 3.5-4 cm gastro-jejunostomy will be performed by linear stapler. | Procedure: Mini Gastric Bypass<br>* Standardization of the techniques will be guaranteed: Mini Gastric Bypass Arm Roux en Y Gastric Bypass arm All patients will have intraoperative measurement of the whole length of bowel from Treitz ligament to the ileocecal junction (expected range 6-8 m).The common limb will be therefore about 2/3 of total small bowel length.<br>|
| Active Comparator: Roux en Y Gastric Bypass<br>Roux en Y Gastric Bypass: The steps of the standard double loop RYGB technique will be followed (17). The gastric pouch will be created 7 cm from the gastro-esophageal junction to obtain a volume of 30-40 ml, and the length of the alimentary limb will be 150 cm and 3.5-4 cm gastro-jejunostomy will be performed by linear stapler. The length of the biliopancreatic limb will be from 65 to 75 cm beyond the ligament of Treitz. The lengths of both limbs should carefully measured with a graduated instrument. The mesenteric defects will be closed. | Procedure: Roux en Y Gastric Bypass<br>* Standardization of the techniques will be guaranteed: Mini Gastric Bypass Arm Roux en Y Gastric Bypass arm All patients will have intraoperative measurement of the whole length of bowel from Treitz ligament to the ileocecal junction (expected range 6-8 m).The common limb will be therefore about 2/3 of total small bowel length.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut Microbiota | To evaluate and compare Roux en Y Gastric Bypass vs Mini Gastric Bypass microbiota profile shift 1 year after surgery and its impact on metabolic and nutritional status after surgery. | 0-6-12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucagon - like peptide 1 (GLP-1) | To measure GLP-1 plasma level before and 12 months after surgery in MGB vs RYGB patients | 0-12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malabsorption, Mini Gastric Bypass, Roux en Y Gastric Bypass