Gastric Procedures for Obesity

NCT ID: NCT01026181

Last Updated: 2017-10-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Morbid Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LSG

Laparoscopic Sleeve Gastrectomy

No interventions assigned to this group

LRYGB

Laparoscopic Roux-en-Y Gastric Bypass

No interventions assigned to this group

LAGB

Laparoscopic Adjustable Gastric Banding

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alberta Health services

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Shahzeer Karmali

BSc, MD, FRCSC

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Pro00002425

Identifier Type: -

Identifier Source: org_study_id