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Trial record 3 of 90 for:    Recruiting, Not yet recruiting, Available Studies | "Malabsorption Syndromes"

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

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ClinicalTrials.gov Identifier: NCT03412149
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Gianfranco Silecchia, University of Roma La Sapienza

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.


Condition or disease Intervention/treatment Phase
Obesity (Disorder) Procedure: Mini Gastric Bypass Procedure: Roux en Y Gastric Bypass Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Malabsorption and Gut Microbiota Profile Changes After Laparoscopic Mini-Gastric Bypass (MGB) vs Roux-en-Y Gastric Bypass (RYGB): a Prospective Multicenter Comparative Study
Actual Study Start Date : March 21, 2018
Estimated Primary Completion Date : October 19, 2019
Estimated Study Completion Date : December 19, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Mini Gastric Bypass
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

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.

Active Comparator: Roux en Y Gastric Bypass
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

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.




Primary Outcome Measures :
  1. Gut Microbiota [ Time Frame: 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 Outcome Measures :
  1. Glucagon - like peptide 1 (GLP-1) [ Time Frame: 0-12 Months ]
    To measure GLP-1 plasma level before and 12 months after surgery in MGB vs RYGB patients



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412149


Contacts
Contact: Marcello Avallone, MD 3384856243 ext 0039 marcello_avallone@libero.it

Locations
Italy
ICOT Hospital Recruiting
Latina, Italy, 04100
Contact: Marcello Avallone    +393384856243    marcello_avallone@libero.it   
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Principal Investigator: Gianfranco Silecchia, MD PhD University of Roma La Sapienza
  Study Documents (Full-Text)

Documents provided by Gianfranco Silecchia, University of Roma La Sapienza:
Study Protocol  [PDF] January 23, 2018


Publications:

Responsible Party: Gianfranco Silecchia, MD PhD Prof. G. Silecchia, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03412149     History of Changes
Other Study ID Numbers: RG11715C7CE1AD8A
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gianfranco Silecchia, University of Roma La Sapienza:
Malabsorption, Mini Gastric Bypass, Roux en Y Gastric Bypass

Additional relevant MeSH terms:
Malabsorption Syndromes
Obesity
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms