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
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