Gastric Procedures for Obesity

This study has been completed.
Sponsor:
Collaborator:
AHS Cancer Control Alberta
Information provided by (Responsible Party):
Shahzeer Karmali, University of Alberta
ClinicalTrials.gov Identifier:
NCT01026181
First received: December 3, 2009
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

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.


Condition
Morbid Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • The outcome measures will be percentage of excess weight loss, BMI, operative time, hospital stays, complications and improvement of comorbidities. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
LSG
Laparoscopic Sleeve Gastrectomy
LRYGB
Laparoscopic Roux-en-Y Gastric Bypass
LAGB
Laparoscopic Adjustable Gastric Banding

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Morbidly obese patients aged from 18 to 65.

Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Shahzeer Karmali, BSc, MD, FRCSC, University of Alberta
ClinicalTrials.gov Identifier: NCT01026181     History of Changes
Other Study ID Numbers: Pro00002425
Study First Received: December 3, 2009
Last Updated: September 22, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014