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

University of Roma La Sapienza

Status: Completed

Conditions: Obesity (Disorder)

Treatments: Procedure: Roux en Y Gastric Bypass; Procedure: Mini Gastric Bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT03412149

RG11715C7CE1AD8A

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Mini Gastric Bypass

Active Comparator group

Description:

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.

Treatment:

Procedure: Mini Gastric Bypass

Roux en Y Gastric Bypass

Active Comparator group

Description:

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.

Treatment:

Procedure: Roux en Y Gastric Bypass