Laparoscopic Gastric Bypass as Metabolic Surgery in Obesity Class 1

Overview

Prospective study including Mexican patients diagnosed with type 2 diabetes and class 1 obesity, undergoing laparoscopic gastric bypass. The objective was to determine short, mid-and long-term outcomes (weight loss, metabolic, morbidity and diabetes remission). A subanalysis was included, based on preoperative usage of one (Group A) or more antidiabetics ± insulin (Group B).

Full Title of Study: “Gastric Bypass as Metabolic Surgery in Obesity Class 1: a Prospective Study of the Short, Mid and Long Term Results Among Mexicans”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 1, 2019

Interventions

  • Procedure: Laparoscopic Gastric Bypass
    • The LGBP was performed using a classic Roux-en-Y procedure. Briefly, a gastric pouch of 30-50 cc was constructed with an antecolic calibrated gastro-jejunal anastomosis (mechanical anastomosis using a 2.5 mm load). The biliary and alimentary limbs measured ≈70 cm and ≈150 cm, respectively, and the jejuno-jejunal anastomosis was also performed in a latero-lateral fashion (mechanical anastomosis using a 2.5 mm load). Mesenteric defects were closed with running non-absorbable sutures and the omentum was divided in every case

Clinical Trial Outcome Measures

Primary Measures

  • Weight Loss
    • Time Frame: 12 months
    • Measure: weight (kilograms)
  • Weight Loss
    • Time Frame: 24 months
    • Measure: weight (kilograms)
  • Weight Loss
    • Time Frame: 36 months
    • Measure: weight (kilograms)
  • Weight Loss
    • Time Frame: 12 months
    • Measure: Body Mass Index
  • Weight Loss
    • Time Frame: 24 months
    • Measure: Body Mass Index
  • Weight Loss
    • Time Frame: 36 months
    • Measure: Body Mass Index
  • Weight Loss
    • Time Frame: 12 months
    • Measure: % excess weight loss
  • Weight Loss
    • Time Frame: 24 months
    • Measure: % excess weight loss
  • Weight Loss
    • Time Frame: 36 months
    • Measure: % excess weight loss
  • Weight Loss
    • Time Frame: 12 months
    • Measure: % total weight loss
  • Weight Loss
    • Time Frame: 24 months
    • Measure: % total weight loss
  • Weight Loss
    • Time Frame: 36 months
    • Measure: % total weight loss

Secondary Measures

  • Complete Diabetes Remission
    • Time Frame: 12 months
    • Definition: no antidiabetic drugs while on glucose <100 mg/dl and HbA1C% <6
  • Complete Diabetes Remission
    • Time Frame: 24 months
    • Definition: no antidiabetic drugs while on glucose <100 mg/dl and HbA1C% <6
  • Complete Diabetes Remission
    • Time Frame: 36 months
    • Definition: no antidiabetic drugs while on glucose <100 mg/dl and HbA1C% <6
  • Late complications
    • Time Frame: After 30 days from surgery
    • Complications requiring re-admssion / re-operation
  • Early complications
    • Time Frame: First 30 days after surgery
    • Complications requiring re-admssion / re-operation

Participating in This Clinical Trial

Inclusion criteria Any sex >18 years-old <60 years-old Class 1 obesity (BMI 30-34.9 kg/m2) Type-2 diabetes mellitus diagnosis (with or without medication) Submitted to laparoscopic gastric bypass Exclusion criteria Other bariatric surgery Revisional surgery Incomplete charts

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • CARLOS ZERRWECK LOPEZ
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: CARLOS ZERRWECK LOPEZ, Professor and Head of Department. – Hospital General Tlahuac

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.