Gastric Procedures for Obesity

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026181
• Other study ID #: Pro00002425
• Status: Completed
• Phase: N/A
• First received: December 3, 2009
• Last updated: May 3, 2017
• Start date: September 2008
• Est. completion date: July 2011

Study information

• Verified date: May 2017
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Alberta Health Services

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Weight	Change of body weight in Kilograms measured at follow-up visits two year after surgery	baseline to 2-year postoperation
Primary	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