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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014