Gastric Procedures for Obesity

Overview

This is a prospective case series study; all morbidly obese patients that need surgical management in Royal Alexandra Hospital will be provided 3 surgical options: Laparoscopic Sleeve Gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LR-en-Y), and laparoscopic gastric banding (LGB), safety and effectiveness will be compared among the 3 groups. The outcome measures will be percentage of excess weight loss, BMI, operative time, hospital stays, complications and improvement of comorbidities.

Full Title of Study: “Phase II Study of Comparing Outcomes of Laparoscopic Sleeve Gastrectomy, Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Gastric Banding to Treat Morbid Obesity”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2011

Arms, Groups and Cohorts

  • LSG
    • Laparoscopic Sleeve Gastrectomy
  • LRYGB
    • Laparoscopic Roux-en-Y Gastric Bypass
  • LAGB
    • Laparoscopic Adjustable Gastric Banding

Clinical Trial Outcome Measures

Primary Measures

  • Change in Body Weight
    • Time Frame: baseline to 2-year postoperation
    • Change of body weight in Kilograms measured at follow-up visits two year after surgery
  • Change in BMI
    • Time Frame: from baseline to 2-year postoperation
    • Patients’ weight and height were measured at follow up visit 2 years post operation. BMI was calculated using the formula: weight (kg)/height(meter)^2

Participating in This Clinical Trial

Inclusion Criteria

  • morbid obese patients aged from 18-65,
  • BMI > 40 kg/m2 or BMI> 35 kg/m2 with severe comorbidities: diabetes, sleep apnea, hypertension etc.

Exclusion Criteria

  • psychiatric illness,
  • substance abuse,
  • previous gastrointestinal surgery, and
  • any patient who transfers from laparoscopic to convention procedure.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alberta
  • Collaborator
    • Alberta Health Services
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shahzeer Karmali, BSc, MD, FRCSC – University of Alberta

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