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OpenTrials
Completed

NCT Number: NCT01026181

Gastric Procedures for 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Health services

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Dec 4, 2009
Registry last updated
Oct 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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