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 (GBP) 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 "malabsorbitive" and there are no studies comparing gut microbiota shift and malabsorption entity in humans after GBP 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.
Study draft: Three european accademic center of excellence for laparoscopic metabolic surgery will be involved. 90 consecutive morbid obese patients (BMI 36-59) (30 for each center) candidate to primary bariatric surgery will be enrolled in 12 months: 45 MGB group and 45 GBP group. Blood tests (Hemoglobin, glucose, HbA1c, cholesterol, triglycerides, T3, T4, TSH, Glp-1 and micronutrient) and stool analysis (gut microbiota, blie acids, macronutrient) before surgery and after 6 and 12 months after will be carried out. Upper GI endoscopy will be performed before and 12 months after surgery.
. The insights on the metabolic and microbiota changes will support post.op. optimal medical treatment and will provide data for the developing of new probiotic drugs.
This is an international multidisciplinary cooperative study on " hot topics" in the file of morbid obesity physiopathology and management involving 3 research units (bariatric/metabolic/gastroenterology) of Sapienza University of Rome , 2 european center of excellence (Gotheborg, Valladolid) and 1 research center of Federico II University of Naples.
Laparoscopic bariatric/metabolic surgery represent the gold standard for the treatment of morbid obesity , however, still are controversial mechanism of action, metabolic effect at long term and criteria for a tailored management. The proposed multidisciplinary research will provide answers and insights .
Laparoscopic MGB represents an emerging surgical option in management of morbid obesity and related comorbidities . It' s classified like a mix procedure " restrictive and malabsorbitive ", however, robust data on the mal-abosorption effect and its impact on the nutritional status are lacking. On the other hand no prospective data on the human gut microbiota and hormones (GLP-1) changes are available. Despite the increasing numbers of procedures performed during the last year, the incidence of bile reflux esophagitis (considered as precancerous lesion) is still controversial in absence of evidence from prospective studies. MGB It' s labelled like a simple, safe and with similar results (weight loss and metabolic improvement) comparing it to GBP. The knowledge of phisiological aspects of MGB colud help surgeons to choose the better procedure for a particulare patient.
The innovation of the present research and the progress beyond the state of the art can be summarized as follows:
1. to evaluate prospectively the entity of nutritional deficiences after MGB and to develop an adequate schedule of postoperative supplementation and follow-up underlying the differences with GBP (health care improvement)
2. to classify rightly the MGB as malabsorbitive or partially malabsorbitive evaluating the impact on GUT microbiota changes at 1 year (change in procedure classification)
3. to compare prospectively the metabolic effects, the changes of bile acids, incretin levels (GLP-1), FXr activity and glycolipid homeostasis of MGB vs GBP (insight homonal pattern)
4. to asses the gut microbiota changes and profile shift and its relation with nutritional status , weight loss and metabolic effect of MGB vs GBP at 1 year (change in postoperative management of metabolic diseases)
5. to ascertain the risk of bile reflux esophagitis at 1 year after MGB in symptomatic and asymptomatic patients (symptomatic vs asymptomatic; correlation between symptoms score ,endoscopy findings and histology) (risk management of precancerous lesion)
The results of the present research could represent the basis for the development of new drugs against obesity based on the gut microbiota modifications and could change the postoperative management of many surgeons/multidisciplinary team , particularly in terms of post-operative follow-up schedule and micro/macronutrients supplementation.