Obesity (Disorder)
Conditions
Keywords
Malabsorption, Mini Gastric Bypass, Roux en Y Gastric Bypass
Brief summary
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.
Interventions
PROCEDUREMini Gastric Bypass
Standardization of the techniques will be guaranteed: 1. Mini Gastric Bypass Arm 2. 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.
PROCEDURERoux en Y Gastric Bypass
Standardization of the techniques will be guaranteed: 1. Mini Gastric Bypass Arm 2. 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.
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut Microbiota | 0-6-12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucagon - like peptide 1 (GLP-1) | 0-12 Months | To measure GLP-1 plasma level before and 12 months after surgery in MGB vs RYGB patients |
Countries
Italy
Outcome results
None listed