Gastric Procedures for Obesity

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

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.

Study Overview

• Status: Completed
• Conditions: Morbid Obesity

• Study Type: Observational
• Enrollment (Actual): 150

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Morbidly obese patients aged from 18 to 65.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
LSG; Laparoscopic Sleeve Gastrectomy
LRYGB; Laparoscopic Roux-en-Y Gastric Bypass
LAGB; Laparoscopic Adjustable Gastric Banding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Weight	Change of body weight in Kilograms measured at follow-up visits two year after surgery	baseline to 2-year postoperation
Change in BMI	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	from baseline to 2-year postoperation

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Alberta Health services

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: December 3, 2009
• First Submitted That Met QC Criteria: December 3, 2009
• First Posted (Estimate): December 4, 2009

Study Record Updates

• Last Update Posted (Actual): October 3, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: Pro00002425