Status:
COMPLETED
Three M Study (Malabsorption, Microbiota, Mini-Gastric Bypass)
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Obesity (Disorder)
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2020
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03412149
Start Date
March 21 2018
End Date
November 19 2020
Last Update
April 28 2021
Active Locations (1)
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1
ICOT Hospital
Latina, Italy, 04100